Clinical Evaluation Naída CI Q30!70!90

Clinical Evaluation Report CER-06-A
July 31, 2017

Naída CI and Accessories
CLINICAL EVALUATION REPORT

____________________________________________
CER 06, Revision A

July 31, 2017
Advanced Bionics
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CLINICAL EVALUATION REPORT
System Device Name HiResolution™ Bionic Ear System
Product Generic Name Cochlear Implant System
Naída CI Q30
Naída CI Q70
Naída CI Q90
Zn-Air Battery Pak
AAA PowerPak™ Accessory
Naída CI Power Adapter
Power Adapter Cable
Naída CI PowerCel™ Charger
PowerCel™ 110
Products covered PowerCel™ 170
PowerCel™ 230
PowerCel™ 110 Mini
Earhook
Naída CI Q90 Acoustic Earhook
RF Cable
T-Mic™ 2
AB myPilot
Naída CI AquaCase™
Advanced Bionics, AG
Legal Manufacturer Laubisrütistrasse 28
8712 Stäfa, Switzerland
CER ID CER-06
Revision Revision A
Date July 31, 2017
The revision starts from A since this CER is done according to MEDDEV 2.7/1 Rev. 4
Revision Purpose
format.
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TABLE OF CONTENTS
EXECUTIVE SUMMARY.............................................................................................................. 5
1.1 PURPOSE OF THIS REVISION OF THE CER......................................................................... 5
Use of MEDDEV 2.7/1 REV 4 – Clinical Evaluation: A Guide for Manufacturers And
Notified Bodies Under Directives 93/42/EEC and 90/385/EEC .......................................... 5
SCOPE OF CLINICAL EVALUATION – STAGE 0 .................................................................. 6
2.1 ACRONYMS & ABBREVIATIONS ......................................................................................... 6
2.2 GENERAL DETAILS ................................................................................................................ 7
Origin of Development of Naída Products on Cert 022 ....................................................... 7
Identification of Naída Products on Cert 022 ...................................................................... 8
Sound Processing Strategies .............................................................................................. 16
Front End Features ............................................................................................................ 16
Optional Phonak Accessories ............................................................................................. 18
Promotional Materials and Claims .................................................................................... 19
Product Labeling ................................................................................................................ 20
Manufacturers .................................................................................................................... 21
Device Classification .......................................................................................................... 21
2.3 SYSTEM DESCRIPTION AND ITS INTENDED PURPOSE ................................................ 23
General Description of a Cochlear Implant (CI) System ................................................... 24
Principle of Operation of the HiResolution Bionic Ear System ......................................... 24
Description of Internal Component: Implantable cochlear stimulator (ICS) .................... 25
External components .......................................................................................................... 26
2.4 ORGANS/TISSUES/BODY FLUIDS CONTACTED BY THE DEVICE .............................. 27
External Part ...................................................................................................................... 27
Internal part........................................................................................................................ 27
2.5 INTENDED THERAPEUTIC AND DIAGNOSTIC INDICATIONS ..................................... 28
Indications for Use for the CI System................................................................................. 28
Indications for Use with the Naída CI Sound Processors Enabled With EAS ................... 28
Contraindications ............................................................................................................... 29
2.6 WARNINGS AND PRECAUTIONS OF THE SYSTEM ........................................................ 29
Warnings............................................................................................................................. 29
Precautions ......................................................................................................................... 30
Possible Adverse Reactions ................................................................................................ 31
2.7 MARKET HISTORY FOR DEVICES UNDER EVALUATION ............................................ 31
Past Modifications .............................................................................................................. 32
Number of Devices on the market ...................................................................................... 33
2.8 CHANGES SINCE LAST REPORT ........................................................................................ 33
Device/System modifications .............................................................................................. 33
New Intended Purposes/Claims/Events that Impact Clinical Evaluation: ......................... 33
IDENTIFICATION OF PERTINENT DATA – STAGE 1........................................................ 34
3.1 CLINICAL BACKGROUND, CURRENT KNOWLEDGE AND STATE OF THE ART ...... 34
3.2 PERTINENT DATA SOURCES ........................................................................................................ 35
APPRAISAL OF PERTINENT DATA – STAGE 2 ................................................................... 36
4.1 DATA SETS IDENTIFIED ...................................................................................................... 36
Appraisal plan .................................................................................................................... 36
4.2 IDENTIFED DATA ................................................................................................................. 37
Bench Data – Design Verification and Validation ............................................................. 37
Non-inferiority clinical study on front-end sound cleaning features ................................. 52
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Post Market Clinical Follow-up Studies/Registries ........................................................... 53

Complaints/Adverse Event Review ..................................................................................... 53
Adverse Events.................................................................................................................... 54
Field Safety Corrective Action/Field Safety Notice Review ............................................... 54
CAPA Review...................................................................................................................... 55
Device/System Risk Assessment .......................................................................................... 55
Custom Made Devices/Compassionate Use/Humanitarian Exemption ............................. 56
Other User Reports............................................................................................................. 56
CLINICAL DATA ANALYSIS – STAGE 3 ............................................................................... 56
5.1 SUMMARY: COMPLIANCE WITH ESSENTIAL REQUIREMENT ON SAFETY (AIMDD
ER1) .......................................................................................................................................... 56
5.2 COMPLIANCE WITH ESSENTIAL REQUIREMENT ON ACCEPABLE BENEFIT/RISK
PROFILE (AIMDD ER1) ......................................................................................................... 57
Risk Assessment .................................................................................................................. 57
Analysis of the Labeling ..................................................................................................... 58
Postmarket Complaint Data ............................................................................................... 58
Key Conclusions from the Literature to Support Positive Risk/Benefit Profile ................. 62
5.3 SAFETY AND PERFORMANCE IN THE LITERATURE .................................................... 63
Naída CI Sound Processors – State of the Art ................................................................... 63
General Lit Review – 2015-2017 ........................................................................................ 65
Efficacy Studies .................................................................................................................. 66
Safety Studies ...................................................................................................................... 72
General Lit Review – 2015-2016 ........................................................................................ 78
Efficacy ............................................................................................................................... 78
Safety .................................................................................................................................. 83
Literature Review – Therapeutic Options by Indication .................................................... 87
5.4 COMPLIANCE WITH ESSENTIAL REQUIREMENT ON PERFORMANCE (AIMDD ER3)
.................................................................................................................................................. 91
5.5 COMPLIANCE WITH ESSENTIAL REQUIREMENT ON ACCEPTABILITY OF SIDE-
EFFECTS (AIMDD ER5)......................................................................................................... 92
5.6 POSTMARKET SURVEILLANCE......................................................................................... 92
Postmarket Surveillance Methods ...................................................................................... 92
PMCF Plan ......................................................................................................................... 92
PMCF Proposal.................................................................................................................. 94
CONCLUSIONS ............................................................................................................................ 95
DATE OF NEXT CLINICAL EVALUATION ........................................................................... 95
DECLARATIONS OF INTEREST AND CURRICULUM VITAE ......................................... 95
DATES AND SIGNATURES ........................................................................................................ 96
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EXECUTIVE SUMMARY
This revision of the Clinical Evaluation Report (CER) is a periodic update of the clinical evidence supporting
safety and performance of the products on EC Certificate I7 1601 77312 022 (Cert 022) when used as
components of the HiResolution™ Bionic Ear System. This includes the Naída CI Q Series family of
processors and accessories (Naída products) which were first approved in March 2013 and updated through
change notifications during the certification period as described in this CER.
A risk/benefit analysis of the Naída products confirms that the benefits of the system continue to outweigh the
risks. Any risks identified have been systematically reviewed and mitigated against, as far as possible. The risk
management process has involved the identification of a comprehensive set of risks, mitigation of these risks to
the lowest level possible and finally a clinical review of the residual risks. The positive risk/benefit profile was
determined by analysis of the published literature, postmarket data, labeling and risk analysis reports generated
since the last significant changes to the Naída products collectively reported in CN 2015-06 (Naída CI Q30 and
Naída CI Q90), CN 2015-09 (Naída CI Q70B) and CN 2015-10 (PowerCel Mini)). The compatibilities of
Naída CI sound processors with third party accessories reported in relation to updates to the SoundWave
Professional Suite fitting software remains unchanged from when they were approved in CE-2016-02-CN and
CE-2016-07-CN.
Comprehensive literature searches have been updated since these submissions cited above. A review of these
updated literature searches concludes that the Naída products still perform as intended, with the same level of
safety and performance. During the certification period, some state of the art (SOTA) standards have been
revised. Additional bench testing and/or gap assessment was performed to ensure ongoing compliance with
SOTA requirements. No testing to SOTA standards was repeated due to a safety or performance issue. Tested
product met the acceptance criteria; the Naída products remain compliant with the SOTA requirements which
apply to them. The postmarket data was reviewed. The complaint rate was stable and ranged from less than 1%
to between 4-5 %. There were no adverse events, field safety corrective actions or safety notices for any
product on Cert 022.
Based on the review of the latest postmarket data, clinical literature, labeling risk assessment and updated
testing, the CER concludes that the Naída products continue to meet the Essential Requirements which apply to
them and they are suitable for continued clinical use.
The products in this CER do not incorporate a medicinal substance, tissues, blood products or components of
animal origin. There are no radioactive components in these products. These products are non-invasive and not
provided sterile.
This CER is being submitted as part of the renewal of the Naída products on Cert 022 which are included in the
HiResolution Bionic Ear System. This CER is being prepared in compliance with the AIMDD 90/385/EEC as
amended by directive 2007/47/EC. This evaluation is based on a comprehensive analysis of available clinical
evidence relevant to the products on Cert 022.
Use of MEDDEV 2.7/1 REV 4 – Clinical Evaluation: A Guide for Manufacturers And
Notified Bodies Under Directives 93/42/EEC and 90/385/EEC
The MEDDEV 2.7/1 Rev 4 – Clinical Evaluation: A Guide for Manufacturers and Notified Bodies Under
Directives 93/42/EEC and 90/385/EEC was used to create this CER. The literature reviews in this CER were
conducted and formatted per the requirements this guidance, with modifications as described below.
The 2015/16 annual general review was performed according to MEDDEV 2.7/1 Rev. 3 guidelines because
they were completed before the updated Rev. 4 guidelines were published. Each review was re-assessed to
determine if using the newer guidelines would change the review’s outcome. This assessment determined that
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the conclusions of the reviews would not change if the new guidelines were used. This decision was reached
for several reasons:
 Each study included in the reviews was thoroughly assessed in terms of scientific rigor, relevance of
outcomes, generalizability to the CI patient population as a whole, appropriate statistical analysis,
report quality and relevance to the scope of the review. The changes required by the new MEDDEV
guidelines require more rigorous documentation of these assessments, but conclusions themselves
would not change because the required appraisals were already performed and incorporated into the
report. Changing the format would not change its conclusions.
 Any paper reporting a safety issue involving AB devices was carefully reviewed by the clinical
research team and already addressed accordingly in the text.
 No new safety issues related to cochlear implantation were discovered in any of the reviewed studies.
 The numerous studies describing efficacy of cochlear implantation overwhelmingly report significant
gains in auditory ability attributed to the implant.
The annual review of literature by Indication is currently in the process of being completed and will be
completed in August 2017 and submitted as a supplement to the initial CER. In the meantime, the Indication
review of 2015-16 prepared per Rev 4 in August 2016 is being submitted.
SCOPE OF CLINICAL EVALUATION – STAGE 0
The Scope serves as a basis for further steps, including the identification of pertinent data presented in Section
3, Stage 1. This section outlines General Details, including a description of the device and the outline of the
clinical evaluation plan. To facilitate review, a table of acronyms and abbreviations applicable to this review is
provided below.
AB Advanced Bionics HiRes HiResolution

ABI Auditory Brainstem Implant HiRes-P HiResolution Paired
AHL Asymmetric Hearing Loss HiRes-S HiResolution Sequential
BICROS Bilateral Contralateral Routing of Signal HF HiFocus
BTE Behind-The-Ear HFMS HiFocus MidScala
BAHA Bone-Anchored Hearing Aid Hz Hertz
BCD Bone Conduction Device ICS Implantable Cochlear Stimulator
CI Cochlear Implant MHz Megahertz
CPI Clinician’s Programming Interface MRI Magnetic Resonance Imaging
CROS Contralateral Routing of Signal RF Radiofrequency
CSR Cumulative Survival Rate SSD Single-Sided Deafness
dB Decibel SW SoundWave (AB programming software)
ESD Electrostatic Discharge UHP Universal Headpiece
HINT Hearing in Noise Test
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Origin of Development of Naída Products on Cert 022
AB and Phonak (a hearing instrument manufacturer) are sister companies within the Sonova Group of hearing
product companies. The Sonova corporate vision is to synergize compatible technologies within Sonova-group
product portfolios to serve patients with hearing loss. The Naída Platform will be the base for future line
extensions leveraging compatible Phonak technologies with proven AB cochlear implant technologies.
The first of these “Naída Platform” devices and accessories were approved by TUV in March 2013 in CN 2013-
01. The predicate of the Naída CI is the AB Harmony sound processor originally introduced to the market in
2006. The Naída CI processors combine the approved sound processing hardware capabilities, form factor and
approved sound processing strategies of the Harmony with Phonak front-end sound processing (FEP) features,
beamforming technology and wireless connectivity (HiBAN). HiBAN is a low-power, short-range digital
inductive 10.6 MHz wireless transmission technology. HiBAN allows for wireless communication between
bilateral Naída sound processors and wireless connectivity to a variety of sound sources, e.g., commercial MP3
players and streaming from cell phones or Bluetooth devices (through Phonak ComPilot). The Phonak
technologies are already used in Phonak hearing instruments and convenience accessories throughout the world.
The form factor of the Naída CI sound processor is smaller than the Harmony sound processor making it more
comfortable to wear on the ear.
The Naída CI Q70 sound processor – foundation of the Naída Platform – is the predicate for the Naída CI Q90
and Q30 sound processors. All three processors have identical hardware and all offer the same sound
processing strategies. The Naída CI Q90 sound processor is a Naída CI Q70 sound processor with the
additional StereoZoom and auto UltraZoom features. The Naída CI Q30 is a sound processor without bilateral
functionality of Naída CI Q70 but with the beamforming feature, UltraZoom. The Naída CI Q30 features and
hardware were all approved in 2013; the Q30 simply removes some of the optional FEPs to distinguish it from
the original Naída CI Q70. The PowerCel Mini was predicated on the original PowerCel Li-ion batteries. The
PowerCel Mini batteries are smaller versions of the approved PowerCel batteries, but with the same capacities.
The clinical use of the PowerCel has not changed. These products were all approved in 2015.
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Identification of Naída Products on Cert 022
This CER is applicable to 19 products listed in Table 1 below and manufactured by Advanced Bionics. Product names (proprietary names) and product model
numbers are shown as they appear in the labeling. NOTE: “-xxx” indicates there are variants; on the actual labeling the xxx value is a number. There are no
design features of the Naída products, indications or target populations which require specific attention or pose special performance or safety concerns.
Table 1: Product Identification Table
Invasive?
duration
Contact
Sterile?
Model
Use
Product Name Notes Product Description & Generic Intended Use Photo/drawing (not to scale)
Number
CI-5260-xxx Naída CI Q30 xxx The Naída CI Q30 sound processor is one part of a
denotes complete cochlear implant system that enables hearing.
intact skin
color The Naída CI Q30 is a behind-the-ear (BTE) sound
>30 days;
Reusable
processor intended to convert sound picked up by the
microphone into electrical signals that are used by the
No
No
cochlear implant to enable hearing.
intact skin
>30 days;
Reusable
No
No
intact skin
>30 days;
Reusable
No
No
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Invasive?
duration
Contact
Sterile?
Model
Use
Number
CI-5500-xxx Zn-Air Battery xxx The Zn-Air Battery Pak is a disposable battery intended to
Pak denotes be a power source for the Naída CI sound processor. The
intact skin
>30 days;
Reusable
color type of disposable battery to be used with Naída CI is size
and 675 Power Implant batteries (675P).
No
No
type
CI-7403 AAA - The AAA PowerPak™ Accessory is a battery powered
PowerPak™ accessory that holds 3 standard off-the-shelf disposable or
intact skin
>30 days;
Reusable
Accessory rechargeable AAA batteries and is intended to be a power
source for the Naída CI sound processor.
No
No
CI-7455-100 Naída CI Power - The Naída CI Power Adapter is intended to connect the
Adapter Naída sound processor to the AAA PowerPak™ using a
Power Adapter Cable.
intact skin
>30 days;
Reusable
No
No
CI-7405-xxx Power Adapter xxx The Power Adapter Cables are intended to connect the
Cable denotes processor power adapter to the AAA PowerPak power
intact skin
>30 days;
Reusable
color accessory.
and
No
No
length
CI-5605 Naída CI - The Naída CI PowerCel™ Charger is intended to recharge

PowerCel™ up to 4 PowerCel batteries simultaneously. It is compatible
intact skin
>30 days;
Charger with the Naída CI PowerCel 110, 170 and 230, as well as
Reusable
the Naída CI PowerCel 110 Mini and 170 Mini
rechargeable batteries.
No
No
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Invasive?
duration
Contact
Sterile?
Model
Use
Number
CI-5511-xxx PowerCel™ 110 xxx The Naída CI PowerCel is a lithium-ion rechargeable

denotes battery intended to power the Naída CI sound processor.
intact skin
>30 days;
Reusable
color
No
No
>30 days; intact

color
Reusable
skin
No
No
>30 days; intact

color
Reusable
skin
No
No
intact skin
>30 days;
Mini denotes battery intended to power the Naída CI sound processor.
Reusable
color
No
No
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Invasive?
duration
Contact
Sterile?
Model
Use
Number

Mini denotes battery intended to power the Naída CI sound processor.
intact skin
>30 days;
Reusable
color
No
No
CI-5710-xxx Earhook xxx The earhook is intended to serve as a fixation aid to hold
intact skin
>30 days;
Reusable
denotes the processor on the ear.
size
No
No
CI-5850-xxx Naída CI Q90 xxx The Naída CI Q90 Acoustic Earhook (Acoustic Earhook)
Acoustic denotes is intended to couple with the Naída CI Q90 Sound
intact skin
>30 days;
Reusable
Earhook side Processor to provide acoustic amplification to Advanced
and Bionics’ cochlear implant recipients.
No
No
length
CI-5415-xxx RF Cable xxx The Naída CI RF cables are intended to connect the Naída
intact skin
denotes CI sound processor to a compatible headpiece.
>30 days;
Reusable
color
and
No
No
length
CI-5835-xxx T-Mic™ 2 xxx The T-Mic™ 2 is a custom in-the-ear microphone intended
denotes to support hearing in noisy environments. The position of
intact skin
>30 days;
Reusable
size the microphone in front of the opening of the ear canal
allows the T-Mic 2 to capture sound as in normal hearing.
No
No
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Invasive?
duration
Contact
Sterile?
Model
Use
Number
CI-5900-100 AB myPilot - The AB myPilot is intended to function as a remote control

(e.g. for setting volume, sensitivity, and selecting different
intact skin
>30 days;
Reusable
hearing programs).
No
No
CI-7431 Naída CI - The Naída CI AquaCase is intended to enclose the Naída
AquaCase™ CI sound processor when the processor is used in aquatic
intact skin
>30 days;
Reusable
and dust-filled environments. This supports activities such
as bathing and swimming.
No
No
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Additional specifications for the Naída products is provided in this section. Tables 2 and 3 below provides the
detailed specifications for the Naída CI sound processors. These are unchanged from the last CER; HiRes
Ultra compatibility was described in the clinical assessment of the HiRes Ultra in CN 2015-08.
Table 2: Naída CI Sound Processor Specifications
Specification Description/Value
Measurements Size H x W x D in mm
Processor Only 26 x 9 x 19
– with Off-the-Ear Power Adapter 40 x 9 x 19
– with PowerCel™ 110 Mini 45 x 9 x 19
– with PowerCel™ 170 Mini 50 x 9 x 19
– with PowerCel™ 110 49 x 9 x 19
– with Zn-Air Battery Pak 53 x 9 x 19
Weight Weight in Grams
Processor Only 6
– with Off-the-Ear Power Adapter 8
– with PowerCel™ 110 Mini 11
– with PowerCel™ 170 Mini 12
– with PowerCel™ 110 11
– with Zn-Air Battery Pak 13 (includes 2 batteries)
Program Button Push-button access up to 5 programs per side for up to 10

programs on a single bilaterally initialized processor
Processor Tri-Color Status LED (green, Indicators for battery status, program number, microphone status,
orange, red) error status and left/right processor identification using AB
myPilot
Processor Internal Alarm Alerts for low battery indications and for changes to program and
volume
Volume Control 10 clicks to top of volume range

10 clicks to bottom of volume range
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Sensitivity Selectable in software and adjustable through AB myPilot
Programmable T-Coil Allows access to phones, loop systems, and Phonak myLink
Operating Temperature 0˚ C to 45˚ C
Humidity Range 95% (non-condensing)
Processing Specifications
Audio Sound Capture 16 bit, 96 dB
Input Dynamic Range 20 dB to 80 dB programmable
Effective Audio Sampling Rate 17.4 kHz
Automatic Gain Control Cambridge dual-loop AGC

Volume Control Up to ±100% electrical dynamic range
Sensitivity Control Programmable + / - 10 dB
Stimulation Rate Up to 83,000 pps
Spectral Bands Up to 120 Bands (software limited)
Supported Strategies HiRes™ Optima-S*, HiRes Optima-P*, HiRes-S with Fidelity
120™*, HiRes-P with Fidelity 120*, HiRes-S, HiRes-P, CIS,
MPS
UltraZoom Feature (Q90, Q70, Q30) Dual-microphone technology designed to focus on sound from a
speaker located in front of the listener
WindBlock Feature (Q90, Q70) Designed to reduce wind noise for improved listening experience
in windy conditions
EchoBlock Feature (Q90, Q70) Designed to improve listening experience in reverberant
environments
SoundRelax Feature (Q90, Q70) Designed to soften sudden, loud noises
Speech Enhancement Algorithm (Q90, ClearVoice™* available with HiRes Fidelity 120™ software (S
Q70, Q30) and P) and HiRes™ Optima sound processing (S and P)
Inductive Link 1 Mbps bandwidth continuous bi-directional
Forward 49 MHz
Backward 10.7 MHz
Battery Life Estimation At fitting time, SoundWave™ software will calculate and display
the battery life estimation by program for each battery option
based on patient specifics
Binaural Processing Specifications
StereoZoom Feature (Q90) Extracts a single voice from a noisy crowd for one-on-one
conversations with less effort
DirectTouch Feature (Q90, Q70) Flexibility to choose hearing direction for ZoomControl and
DuoPhone
DuoPhone Feature (Q90, Q70) Simultaneously stream calls to both processors
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QuickSync Feature (Q90, Q70) Instantaneously change programs or volume to both processors
with one touch
ZoomControl Feature (Q90, Q70) Designed to focus on sound coming from the front, back, left or
right of the listener
Phonak ComPilot Accessory (Q30) Stream information to the Naída CI Q30 and to a Phonak
compatible hearing instrument
Phonak DECT Phone (Q30) Stream cordless phone calls to the Naída CI Q30 and a Phonak
compatible hearing instrument
Phonak EasyCall Accessory (Q30) Stream cell phone calls directly to the Naída CI. Can also stream
to a compatible Phonak hearing instrument
Compatibility with primary components
Implant HiRes Ultra, HiRes 90K™ Advantage, HiRes 90K™, and CII
Headpieces Universal Headpiece (UHP) , AquaMic™ headpiece
(for use with AquaCase™ enclosure)
Fitting Software SoundWave Professional Suite, versions 2.3 and higher
Table 3: AB Accessories Specifications

Specifications Description/Value
Universal Headpiece With omni-directional microphone
AquaMic™ Headpiece With waterproof headpiece microphone (when used with
AquaCase)
Cable Colors Black, Beige, Brown, White
Headpiece Specifications
Microphones Universal Headpiece microphone, T-Mic™ 2 microphone,
AquaMic headpiece microphone (for use with AquaCase
enclosure), dual microphone (front and back processor
microphone)
Microphone Features Omni-directional, UltraZoom, ability to listen to multiple
microphone sources at once
Frequency Range 150 Hz to 10,000 Hz
Battery Specifications
Power Options Zn-Air Pack (Zn-Air batteries off-the-shelf)
Li-Ion
AAA PowerPak (AAA batteries off-the-shelf). Use with Naída CI
Power Adapter for off-ear wearing option.
Battery Cycle Time Operating time based on patient-specific programming settings,
skin flap thickness and features used.
Lithium-Ion Battery Charger Charger for 4 Lithium-Ion PowerCel™ batteries
Tri-colored LED indicators
USB or DC powered
Other AB Accessories
Earhooks/Microphones Earhooks (small, standard)
T-Mic™ 2 (small, medium, large)
Acoustic Earhook (L/R, 00, 0, 1, 2, 3) on available for Q90
Wearing Options Right and left clips, Naída CI Power Adapter
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Table 3: AB Accessories Specifications

Specifications Description/Value
Listening Check Portable diagnostic device for checking input sources
AquaCase Enclosure Certified IP68-rated container for protection from water and dust
AB myPilot Remote Control Unilateral and bilateral access to volume, program, sensitivity,
status readout, source specific Listening Check and ZoomControl
Sound Processing Strategies
The Naída CI sound processors can be used with any HiResolution sound processing strategy: HiResolution,
HiResolution Fidelity 120, or HiResolution Optima. HiResolution Fidelity 120 and HiResolution Optima use
current steering to provide up to 120 channels for conveying precise spectral information. HiResolution Optima
provides the high spectral resolution of HiResolution Fidelity 120 with less power requirements, prolonging
battery life. The Naída CI sound processor has a wide input dynamic range of 80 dB and uses dual action
automatic gain control (AGC) to manage soft and loud sounds separately and reduce distortion. The AutoSound
feature automatically adjusts the overall sound level so that the user does not have to regulate volume control
manually in quiet and loud environments. ClearVoice™, a sound processing strategy designed to enhance
hearing in in noisy environments by reducing the background noise level, can also be used with a Naída CI
sound processor.
There has been no change to the sound processing strategies submitted in the last clinical evaluation.
Front End Features
The front-end processing features (FEP) are being marketed on a tiered basis, capable of supporting a variety of
users and price-points. To differentiate between these software-enabled feature sets in the field, AB associated
each feature set with a different Naída CI sound processor model name. Naída CI Q30 provides the basic
feature set; Naída CI Q70 the mid-range feature set; and Naída CI Q90 the complete feature set.
The Naída CI family sound processor hardware is identical for all Naída CI models. Only the firmware
enabling the tiered feature sets (Q30, Q70 and Q90) is different between the models. The set of features which
can be downloaded to a given hardware model is controlled by firmware installed in the processor during
manufacture at Advanced Bionics and cannot be changed in SoundWave (fitting software) during fitting.
FEPs attenuate sounds based on environmental challenges, such as a noisy restaurant or a large hall with a
reverberant echo. “Beamforming” features focus sound from a specific direction to assist in those challenging
environments. Important characteristics of FEPs and beamforming are:
 FEPs and beamforming are optional and implemented based on clinician discretion.
 FEPs and beamforming are not required for medical treatment of hearing loss.
 FEPs and beamforming do not completely attenuate or focus sound; there is always some residual
sound outside the focus area.
 FEPs and beamforming are not sound processing strategies.
 FEPs and beamforming contain no safety features; safety features of the system are controlled by the
sound coding firmware in the processor and implant.
 FEPs and beamforming do not “command” or impose a behavior or control over the sound
coding/strategy algorithms.
 FEP and beamforming have no effect on sound coding or stimulation because the strategies simply
process the final input signal (illustrated below in the red circle). The strategy firmware cannot
distinguish if FEP or beamforming had been applied to the final input signal. This is illustrated in
Figure 1 below.
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Acoustic input signal into Sound Coding (SP strategy)

sound coding module hardware/firmware
Figure 1: Illustration of FEP/Beamforming input signal to Sound Processing Strategy hardware/firmware
Table 4 lists and describes the available front end sound processing features for the Naída CI sound processors.
There has been no change to the FEP and beamforming features since the last clinical evaluation.
Table 4: Summary of FEP and Beamforming Features
Feature Naída Naída Naída CI Feature/Strategy Description

CI Q90 CI Q70 Q30
UltraZoom Yes Yes Yes Enhances listening when focused on a person

speaking in front of you. Must be selected by user.
QuickSync Yes Yes No Bilateral hearing – one-touch control which syncs

program and volume settings from one processor to
the other.
DuoPhone Yes Yes No Bilateral hearing – Left/right ZoomControl option

with a predefined AUX/mic setting. Used to stream
audio from a phone call from one ear to the
contralateral ear.
ZoomControl Yes Yes No Allows the user to choose which direction to focus
hearing by focusing audio input from front or back.
WindBlock Yes Yes No This is a comfort feature. Reduces wind noise

arriving at the microphone to improve comfort and
ease listening when listening in the presence of
wind.
SoundRelax Yes Yes No This is a comfort feature. Quickly adjusts sound

level in response to sudden and/or unexpected
sounds
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Table 4: Summary of FEP and Beamforming Features
Feature Naída Naída Naída CI Feature/Strategy Description

CI Q90 CI Q70 Q30
EchoBlock Yes Yes No This is a comfort feature. Improves comfort and

ease of listening when listening in environments
with a high degree of reverberation or echo.
StereoZoom Yes No No Creates a narrow beam to focus on one person in

front of you when in a noisy environment (bilateral
recipients only).
Auto Yes No No This is a noise management feature. Enhances

UltraZoom listening when focused on a person speaking in
front of you.
Automatically activates in a noisy environment such
as a restaurant when listening to an individual
speaker from the front.
Optional Phonak Accessories
There are several convenience items which are compatible with the Naída CI sound processors but are
manufactured and sold by Phonak or a Phonak subsidiary for use with their hearing instruments. Phonak
products are claimed as optional convenience items for Naída product users; these products are not
required for medical treatment with the cochlear implant system and have no effect on sound processing
strategies. See Table 5.
Table 5: Compatible Off-the-Shelf Phonak Accessories

Parameter Description/Value
Phonak ComPilot Accessory Stream music, calls, FM and other media unilaterally, bilaterally
and bimodally with Phonak compatible hearing instrument.
Ability to make volume and program adjustments
Phonak TVLink II Accessory Stream high-quality TV audio to recipient’s Naída CI sound
processors, or a Naída CI processor and a compatible Phonak
hearing aid via the ComPilot access
Phonak RemoteMic Accessory Lightweight microphone for one-on-one communication over
distance stream speech to recipient’s Naída CI sound processors,
or a Naída CI processor and a compatible Phonak hearing aid
Phonak DECT Phone Stream cordless phone calls directly to the Naída CI. This phone
also has the ability to stream to a compatible Phonak hearing
instrument.
Phonak EasyCall Accessory Stream cell phone calls directly to the Naída CI. This accessory
also has the ability to stream to a compatible Phonak hearing
instrument.
Naída Link Hearing Instrument Hearing aid which can be programmed with some features
common to the Naída CI sound processor. Option to stream
wirelessly to Naída CI processor using HiBAN.
Roger System Roger 17 Receiver: Connects to Naída CI sound processor.
Receives audio streamed from Roger system microphones.
Roger Pen: Streams a speaker’s voice or multiple speakers’ voices
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Table 5: Compatible Off-the-Shelf Phonak Accessories

Parameter Description/Value
to Roger receiver while reducing noise; can also be used for
streaming audio from cell phones, TV, and multimedia.
Roger Clip-On Mic: Streams voice to Roger 17 receiver to

facilitate one-to-one communication in loud noise and over
distance; can also be used for streaming audio from TV and
multimedia.
Promotional Materials and Claims
The Naída product performances are summarized in brochure 028-M588-02 Rev A. The claims are supported
by the evidence listed on page 39 of the brochure. The Naída CI sound processors have individual brochures
which are listed below in Table 7. Compatible accessories for the processors are also described in the processor
brochures. Information about the Naída products is also available on the Advanced Bionics website at the links
below in Table 7.
Table 7: Website Links to Naída Product Information

Product Number Product Name Brochure Website Link
CI-5260-xxx; xxx Naída CI Q30 028-M561-xx https://www.advancedbionics.com/content/a
denotes color (xx = language) dvancedbionics/com/en/home/products/proce
ssors/Naída-ci/Naída-ci-q30.html
CI-5500-xxx; xxx Zn-Air Battery See Naída
denotes color and type Pak brochures
CI-7403 AAA See Naída
PowerPak™ brochures
Accessory
CI-7455-100 Naída CI Power See Naída
Adapter brochures https://www.advancedbionics.com/content/a
CI-7405-xxx; xxx Power Adapter See Naída dvancedbionics/com/en/home/products/acces
denotes color and Cable brochures sories/power.html
length
CI-5605 Naída CI See Naída
PowerCel™ brochures
Charger
CI-5511-xxx; xxx PowerCel™ 110 See Naída
denotes color brochures
CI-5517-xxx; xxx PowerCel™ 170 See Naída https://www.advancedbionics.com/content/a
denotes color brochures dvancedbionics/com/en/home/products/acces
CI-5523-xxx; xxx PowerCel™ 230 See Naída sories/power.html
denotes color brochures
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Table 7: Website Links to Naída Product Information

Product Number Product Name Brochure Website Link
denotes color Mini brochures
denotes color Mini brochures
CI-5710-xxx; xxx Earhook See Naída NA, see Naída processor brochures
denotes size brochures
CI-5850-xxx; xxx Naída CI Q90 See Naída CI https://www.advancedbionics.com/content/a
denotes side and Acoustic Q90 brochure dvancedbionics/com/en/home/products/Naíd
length Earhook a-eas.html
CI-5415-xxx; xxx RF Cable See Naída NA, see Naída processor brochures
denotes color and brochures
length
CI-5835-xxx; xxx T-Mic™ 2 See Naída https://www.advancedbionics.com/content/a
denotes size brochures dvancedbionics/com/en/home/products/acces
sories.html
CI-5900-100 AB myPilot See Naída https://www.advancedbionics.com/content/a
brochures dvancedbionics/com/en/home/products/acces
sories.html
CI-7431 Naída CI See Naída https://www.advancedbionics.com/content/a
AquaCase™ brochures dvancedbionics/com/en/home/products/soluti
on-finder/water-innovations.html
The brochures and reference materials are provided in Appendix 1.
Product Labeling
The Instructions for Use are summarized in Table 8 and are providcd in Annex 6 of this submission in hard
copy and Appendix 2 of this CER in the electronic copy.
Table 8: Naída Product IFUs and User Guides

Model Number Model Description IFU
CI-5260-xxx Naída CI Q30 (xxx denotes color) 029-M505-85B
CI-5245-xxx Naída CI Q70 (xxx denotes color) 029-M506-85C
CI-5280-xxx Naída CI Q90 (xxx denotes color) 029-M496-85C
CI-5500-xxx Zn-Air Battery Pak (xxx denotes color and type) 029-M514-85A
CI-7403 AAA PowerPak™ Accessory 029-M523-85A
CI-7455-100 Naída CI Power Adapter 029-M521-85A
CI-7405-xxx Power Adapter Cable (xxx denotes color and length) 029-M528-85A
CI-5605 Naída CI PowerCel™ Charger 029-M517-85A
CI-5511-xxx PowerCel™ 110 (xxx denotes color) 029-M513-85A
CI-5517-xxx PowerCel™ 170 (xxx denotes color)
CI-5523-xxx PowerCel™ 230 (xxx denotes color)
CI-5521-xxx PowerCel™ 110 Mini (xxx denotes color)
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Table 8: Naída Product IFUs and User Guides

Model Number Model Description IFU
CI-5527-xxx PowerCel™ 170 Mini (xxx denotes color)
CI-5710-xxx Earhook (xxx denotes size) 029-M516-85A
CI-5850-xxx Naída CI Q90 Acoustic Earhook (xxx denotes side and length) 029-M508-49A
CI-5415-xxx RF Cable (xxx denotes color and length) 029-M515-85A
CI-5835-xxx T-Mic™ 2 (xxx denotes size) 029-M516-85A
CI-5900-100 AB myPilot 029-M520-85A
CI-7431 Naída CI AquaCase™ 029-M529-85A
Manufacturers
Legal Manufacturer Advanced Bionics, AG

(Owner) Laubisrütistrasse 28
Manufacturing sites Advanced Bionics, LLC
28515 Westinghouse Place
Valencia, California 91355
Advanced Bionics LLC

12740 San Fernando Road
Sylmar CA 91342, USA
Advanced Bionics, AG
Laubisrütistrasse 28
Device Classification
The HiResolution Bionic Ear System Cochlear Implant System is defined as an Active Implantable Medical
Device per industry standards ISO 14708-7 and EN 45502-2-3: “A cochlear implant system or auditory
brainstem implant system is an active implantable medical device comprising implantable and non-implantable
parts (external parts).”
In the European Union, the Cochlear Implant System is regulated by the Directive 90/385/EEC as amended by
directive 2007/47/EEC which defines an Active Implantable Medical Device as: “any active medical device
which is intended to be totally or partially introduced, surgically or medically, into the human body or by
medical intervention into a natural orifice and which is intended to remain after the procedure”. Therefore, the
HiResolution Bionic Ear System is placed on the European market according to the amended Directive
90/385/EEC.
For the purposes of clinical evaluation, the following Global Medical Device Nomenclature (GMDN) Code
has been assigned for the entire HiResolution Bionic Ear system:
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Code GMDN Term Description

35643 Cochlear A battery-powered assembly of devices [cochlear implant (CI)] intended for
implant system the partial restoration of auditory sensation to a profoundly deaf person. It
consists of an inner electrode array implanted in one cochlea and connected
to a receiver-stimulator implanted near the ear; and an externally worn
microphone-sound processor, battery pack, coil cable, and coil (transmitter).
Sound waves are converted into electrical signals by the sound processor
(transducer) and sent to the coil (transmitter) via the coil cable. The coil
transmits the signals to the receiver-stimulator and ultimately to the cochlea
via the electrode array. Dedicated implantation instruments may be included
The GMDN codes for each part of the system are provided in Table 9 below. Where a GMDN code does not
exist for a specific part of the HiResolution Bionic Ear System then a general 47373 code was assigned.
Table 9: Product-Specific GMDN Codes

Product GMDN GMDN Term GMDN Description
Number Code
CI-5260-xxx 47374 Cochlear implant The non-sterile external portion of a cochlear implant system
CI-5245-xxx 47374 system sound [cochlear implant (CI)] that typically consists of a battery-
CI-5280-xxx 47374 processor powered microphone/transmitter (transducer) designed to
convert sound waves from the environment into electrical
signals which are transmitted to the implantable portion of the
device, via a coil, for the partial restoration of auditory
sensation in a profoundly deaf person. Also known as a speech
processor, it is typically worn like a behind-the-ear (BTE)
hearing aid.
CI-5500-xxx 58185 Cochlear The non-sterile external portion of a cochlear implant system
CI-7403 58185 Implant System [cochlear implant (CI)] that typically consists of a holder or
Battery Pack container designed to hold batteries that supply direct current
(DC) to all of the electrically-powered/dependent components
of the CI. It is typically worn behind-the-ear (BTE) and may
include an on/off switch. This is a reusable device.
CI-7455-100 61245 Cochlear implant A device designed to be used with a cochlear implant system
system to connect the sound processor to power options, e.g. battery
connector pack, and/or to enable connections to external devices that
may be used as peripherals to the implant system. This is a
reusable device.
CI-7405-xxx 47487 Electrical-only A non-patient-contact, insulated, electrical cord with a
medical device connector (plug) at both ends designed to transmit electrical
connection power and/or signal (data) between medical devices (e.g., to
cable, reusable connect a lead, electrical catheter, headpiece, or monitor to a
parent device). It is not intended to connect directly to patient-
worn electrodes (i.e., it is not a lead), is not intended to
connect to the mains (i.e., not a mains power cable), does not
generate any type of power and/or signal, and has no
additional non-electrical conducting or processing
functionality. This is a reusable device.
CI-5605 17115 External device An electrically-powered device designed to supply an
battery charger electrical charge, via a direct/wired or wireless connection, to
an external parent device (i.e., nonimplantable device) or
external battery pack, to recharge it for operation.
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Table 9: Product-Specific GMDN Codes

Product GMDN GMDN Term GMDN Description
Number Code
CI-5511-xxx 34158 Secondary A rechargeable set of electrochemical cells, or a single cell,
Battery designed to store chemical energy and release it in the form of
CI-5517-xxx 34158 electrical energy to provide power for active implantable
medical devices or external medical instruments, for backup
power for programmable devices that must retain electronic
CI-5523-xxx 34158
information, or to power portable or other medical devices
when it is not possible or convenient to use the line supply.
CI-5521-xxx 34158 The size, shape, and chemical composition of the battery
should be specified according to the requirements of the
CI-5527-xxx 34158 appropriate IEC standard.
CI-5710-xxx 61243 Cochlear implant A small hook-shaped or formable device designed to be

system sound attached to a cochlear implant sound processor to facilitate
processor wearing behind the ear. It is typically made of synthetic
earhook polymer materials. This is a reusable device.
CI-5850-xxx 62901 Cochlear implant A small device designed to be attached to a cochlear implant
system sound system sound processor and extended into the external ear
processor canal to function as a speaker providing amplified acoustic low
speaker frequency sound to the eardrum, as a conjunct to the electrical
input to the implant. It is intended for patients with improvable
low frequency hearing and is typically made of synthetic
polymer materials with metallic components. This is a single-
patient, reusable device.
CI-5415-xxx 58186 Cochlear implant The non-sterile external portion of a cochlear implant system
system coil cable [cochlear implant (CI)] that typically consists of a flexible and
insulated electrical conductor with dedicated connectors
designed to conduct electrical signals from the CI sound
processor to the CI coil which are worn behind-the-ear (BTE).
CI-5835-xxx 61250 Cochlear implant small device designed to be attached to a cochlear implant
system sound system sound processor to function as a microphone, an audio
processor audio jack, room loop receiver/booster, and/or a wireless connection
attachment receiver. It may be hook-shaped to facilitate wearing behind-
the-ear (earhook), or another configuration. It is typically
made of synthetic polymer materials with metallic
components. This is a reusable device.
CI-5900-100 57885 Hearing device A battery-powered device designed to be operated by the
remote control wearer of a hearing aid or a hearing implant system to enable
discreet wireless (remote) adjustments to the device (e.g.,
volume and program changes). It is designed to be
conveniently portable (e.g., carried in a pocket, handbag, or
attached to a key ring).
CI-7431 61151 Cochlear implant A container intended to be used to house and protect a
system sound cochlear implant system sound processor from water and
processor case particulates, enabling a patient to use it in wet and rugged
environments (e.g., for swimming, showering). It is typically
made of waterproof and dustproof synthetic polymer materials,
with a watertight seal. This is a reusable device.
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General Description of a Cochlear Implant (CI) System
Cochlear implant systems are a standard-of-care treatment offering significant hearing benefit to adults and
children with severe-to-profound hearing loss who cannot benefit from conventional hearing aid devices. The
cochlear implant directly stimulates the auditory nerve, bypassing the need for functioning receptor cells in the
inner ear (Turner 2006). All approved cochlear implant companies have the same system architecture for the
cochlear implant, which is powered by an external system. This system architecture has remained unchanged
for over 30 years. A cochlear implant system consists of:
 An externally worn sound processor, headpiece, earhook (which could contain a microphone) and
power source (battery);
 Implantable device containing an antenna coil, receiver/stimulator electronics package and electrode
array;
 Custom fitting software and programming interface used to program the external sound processor;
 Accessories (e.g. cables, caps/covers, remote control or an adapter)
Principle of Operation of the HiResolution Bionic Ear System
The HiResolution Bionic Ear System is a cochlear implant system designed to provide useful hearing to
individuals with severe-to-profound hearing loss or who have residual low-frequency hearing sensitivity and
severe to profound high-frequency sensorineural hearing loss (EAS mode). It consists of internal and external
components. The system converts sound into electrical stimuli that activate the auditory nerve. The auditory
nerve then sends information to the brain, where it is interpreted as sound. The stimulation parameters for the
system are controlled via digital signal processor (DSP) software on the processor. The parameters of the
stimulation are patient-specific and are configured by a clinician within preset safe limits using the SoundWave
fitting software run on a standard personal computer.
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Figure 2 illustrates the auditory pathway with the cochlear implant (with a Naída CI sound processor).
Figure 2: Auditory Pathway with Cochlear Implant System
1. Sound is captured by System

microphones. Note: the System
can also receive sound from AUX
audio input sources.
2. Sound processor converts the
captured sound into detailed
digital information. The processor
sends power and digital audio
information via the headpiece to
the implant which is implanted
under the skin.
3. The implant converts the digital
information from the processor
into electrical stimulation which
is delivered to the auditory nerve
through the electrode array.
4. The auditory nerve sends
impulses to the brain where they
are interpreted as sound.
1) Microphones: T-Mic™ 2, Universal Headpiece (UHP)/AquaMic™.

2) Sound Processors: Naída CI Q Series (shown). Others (not shown): Harmony, Neptune.
3) Headpiece, with cable: UHP/AquaMic
4) Implant: HiRes™ 90K Advantage CI HiFocus™ MS Electrode. Other (not shown): HiRes Ultra.
5) Human auditory nerve
Description of Internal Component: Implantable cochlear stimulator (ICS)
The internal component or implantable cochlear stimulator (ICS) includes a receiver and an electrode which are
implanted surgically under the skin behind the ear. The implant electronics are contained within a hermetically
sealed titanium case connected to an antenna coil assembly with a removable magnet which are then encased in
silicone (See Figure 3). The antenna coil receives power and data over an inductively coupled link from the
external sound processor system. The electrode consists of a fantail, electrode lead, and electrode array. The
electrode array (distal) is connected to the implant through the electrode lead. There is a choice of 3 electrode
arrays (for Advantage), each with 16 contacts: HiFocus Mid-Scala, HiFocus 1j, and HiFocus Helix. The lead,
which extends from the fantail to the electrode array, refers to the silicone carrier in which the electrode wires
are enclosed. The fantail is directly connected to the electronics in the implant. The antenna coil assembly and
the electrode lead assembly connect to the electronics inside the hermetic electronics housing.
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Hires 90K Advantage implant HiRes Ultra implant
Electrode configurations: Electrode configurations:

 HiFocus™ 1j Electrode  HiFocus™ MS Electrode
 HiFocus Helix™ Electrode
 HiFocus™ MS Electrode
Figure 3: Internal Component, HiResolution Bionic Ear System
External components
2.3.4.1 Sound processor
The sound processor is available in two functionally-similar configurations: off-ear (body-worn) and behind-
the-ear (BTE). Figure 4 depicts the current CE-marked sound processors. Body worn processors include the
Platinum Sound Processor (PSP) or Neptune. BTE processors include the Harmony or Naída CI series sound
processors (Naída CI Q30, Q70 or Q90). The Naída addressed in this CER is in the upper left.
BTE processors Body-worn processors

Naída CI Q Series processor Neptune
Harmony PSP
Figure 4: AB Sound Processors (connected to earhook and/or power option; arrow indicates processor)
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All sound processor and headpieces function as follows: the sound processor captures sound from a microphone
or auxiliary input via an analog-to-digital (A/D) converter. During sound coding, the signal is analyzed and
processed by the DSP firmware whereby the energy content in different spectral bands is calculated in
accordance with the sound coding (processing) strategy. The energy calculations are converted into current
values per a patient-specific program, also called a “map”. These current values are delivered to the implant
transcutaneously via a bi-directional inductive link via the headpiece. The processor requires a power source.
For the convenience of patients, AB offers custom Li-ion batteries and off-the-shelf Zn-Air and AAA power
options for Naída users. These are also shown in Figure 4.
2.3.4.2 Headpiece
The headpiece contains an omni-directional microphone which picks up sounds. The sound signal is then
delivered via the headpiece cable to the sound processor, which analyzes the sound and converts it to a digital
signal. The signal is then sent back along the headpiece cable to the headpiece, where it is sent transcutaneously
to the implant. Headpieces include the Universal Headpiece (UHP) and Concave UHP, and AquaMic. See
Figure 5.
Figure 5: UHP (left) and AquaMic (right)
2.3.4.3 Fitting Software
The Fitting Software system consists of a standard personal computer running Microsoft Windows with
approved Advanced Bionics SoundWave Professional Suite Software and CPI (Clinician Programming
Interface). An audiologist or other trained health professional uses the fitting software to set parameters in a
strategy to tailor a program for a specific recipient. The CPI-3 provides a hub between the computer and the
sound processor. Additionally, it provides power to the sound processor during the fitting procedure. The power
supply is connected to a standard wall outlet and to the CPI-3. With the Naída CI product platform, SoundWave
can also be used to program optional features such as FEP and beamforming, ClearVoice and enable
compatibility with accessories.
External Part
The external products on Cert 022 are only intended and labeled for contact with intact skin. There are no
sterile or invasive products on Cert 022. All products are reusable.
Internal part
For the implantation of the internal part of the CI system (HiRes Ultra and HiRes 90K Advantage implants) the
patient has to undergo a surgical intervention where the surgeon deploys the implant by an insertion through a
skin incision (e.g. conventional incision approach; minimal incision approach) located behind the ear. The
length of the incision, as well as the location of the incision itself, are decisions each implanting surgeon must
consider. The titanium housing of the implant then rests in a small depression (recessed well) located in the
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osseous structure called the mastoid bone. A small hole in the cochlea is created at or adjacent to the round
window (e.g. conventional cochleostomy, round window or a modified (extended) round window approach)
and the surgeon threads the electrode array of the implant through this hole into the cochlea. The incision
behind the ear is closed so that the implant device remains beneath the skin.
An additional surgical intervention might be required if a patient has to remove and replace the CI internal
magnet to undergo an MRI scan. For both the surgical interventions mentioned above, Advanced Bionics
provides a set of surgical tools to assist the surgeon. There are two types of tools: single use sterile tools and
reusable tools. The tools are optional and common OR tools can be used instead.
Indications for Use for the CI System
The HiResolution Bionic Ear System is intended to restore a level of auditory sensation to individuals with
severe-to-profound sensorineural hearing loss via electrical stimulation of the auditory nerve.
Adults
 18 years of age or older.

 Severe-to-profound bilateral sensorineural hearing loss or severe-to-profound unilateral hearing loss.
 Post-lingual onset of severe or profound hearing loss.
 Limited benefit from appropriately fitted hearing aids, defined as scoring 50% or less on a test of open-
set sentence recognition (HINT Sentences).
Children
 12 months through 17 years of age.

 Severe-to-profound bilateral sensorineural deafness or severe-to-profound unilateral hearing loss.
 Use of appropriately fitted hearing aids for at least 6 months in children 2 through 17 years of age, or at
least 3 months in children 12 through 23 months of age. The minimum duration of hearing aid use is
waived if x-rays indicate ossification of the cochlea.
 Little or no benefit from appropriately fitted hearing aids. In younger children (< 4 years of age), lack
of benefit is defined as a failure to reach developmentally appropriate auditory milestones (such as
spontaneous response to name in quiet or to environmental sounds) measured using the Infant-Toddler
Meaningful Auditory Integration Scale or Meaningful Auditory Integration Scale or ≤ 20% correct on a
simple open-set word recognition test (Multisyllabic Lexical Neighborhood Test) administered using
monitored live voice (70 dB SPL). In older children (≥ 4 years of age), lack of hearing aid benefit is
defined as scoring ≤12% on a difficult open-set word recognition test (Phonetically Balanced-
Kindergarten Test) or ≤ 30% on an open-set sentence test (Hearing In Noise Test for Children)
administered using recorded materials in the sound field (70 dB SPL).
Indications for Use with the Naída CI Sound Processors Enabled With EAS
When the HiResolution Bionic Ear system is used in conjunction with the Naída sound processors enabled with
the EAS and the Acoustic Earhook, the system provides a combined type of stimulation, electric plus acoustic,
and the target population is different from the population using different sound processors. The indications with
the electric and acoustic stimulation are the following:
The HiResolution™ Bionic Ear system with the Naída CI Q90 EAS system is designed to provide
electric and acoustic stimulation for patients with partial deafness (functional low frequency
residual acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing
loss). The system is indicated for unilateral or bilateral use in patients who have residual low-
frequency hearing sensitivity and severe to profound high-frequency sensorineural hearing loss.
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Contraindications
The HiResolution Bionic Ear System is contraindicated in patients with
 deafness due to lesions of the acoustic nerve or central auditory pathway

 active external or middle ear infections
 cochlear ossification that prevents electrode insertion
 absence of cochlear development
 tympanic membrane perforations associated with recurrent middle ear infections.
Warnings
Bacterial meningitis has been reported in users of the system and other cochlear implants, especially in children
under the age of 5. The cause of meningitis in these cases has not been established. A small percentage of deaf
patients may have congenital abnormalities of the cochlea (inner ear) which
predispose them to meningitis even prior to implantation. Patients who become deaf as a result of meningitis
are also at increased risk of subsequent episodes of meningitis compared to the general population. Other
predisposing factors may include young age (<5 years), otitis media, immunodeficiency, or surgical technique.
The cochlear implant, because it is a foreign body, may act as a nidus for infection when patients have bacterial
illnesses.
The incidence rate, although low, appears to be higher than the age-adjusted rate for the general population. The
fatality rate as a result of meningitis also appears to be higher. Adequate epidemiological data are not available
to determine whether the incidence and fatality rates are, in
fact, definitively different from the general population, whether there are special risk factors in the cochlear
implant population, or whether different cochlear implant models pose different risks.
Adults and parents of children who are considering a cochlear implant or who have received cochlear implants
should be advised of the risk of meningitis. They should also be informed of the availability of vaccines that
have been shown to substantially reduce the incidence of meningitis in the general population resulting from the
organisms that commonly cause bacterial meningitis (Streptococcus pneumoniae, Haemophilus influenzae,
Meningococcus). National health agencies frequently provide
updated information on the safety and utility of specific vaccines and offer recommendations reflecting local or
regional conditions. Physicians or patients should refer to the applicable authorities for this information. These
vaccines can be administered by pediatricians, primary care/family physicians, and infectious disease
specialists.
Adults and parents of children who have received cochlear implants should be counseled on the symptoms of
meningitis, the need to seek immediate medical care if any symptoms appear, and the need to advise the
treating physicians of the presence of the cochlear implant and of the possibility of
increased risk of meningitis associated with implant. They should also be counseled to obtain medical care at
the first signs of otitis media.
 Extreme direct pressure on the implanted device, up, down, left or right may cause the implant to move
and possibly dislodge the electrode array.
 A direct impact to the implant site may damage the implant and result in its failure to function. There
have been instances of Advanced Bionics device failure as a result of a child hitting his/her head at the
site of the implanted device. None of these reported incidents have resulted in a concussion or fracture
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of the skull. In all cases, the failed device was explanted and a new device reimplanted with no further
complications.
 The long-term effects of chronic electrical stimulation are unknown. Clinical experience with the
system since 1991 has shown no adverse effects of chronic electrical stimulation on patient
performance, electrical thresholds, or dynamic range.
 Electrode displacement can occur if the electrode is not inserted properly. Surgeons should be
proficient in the use of the electrode insertion tool. Failure to follow the recommended surgical
procedure for placement and stabilization of the HiRes Ultra implant increases the risk of device
migration or extrusion, and of damage resulting from impact trauma, including breakage of the
electrode lead wires. Creating a recessed bed for the implant and securely stabilizing the device in place
are critical elements of the surgical procedure.
 Electrosurgical instruments must not be used within the vicinity of the implant or electrode.
Electrosurgical instruments are capable of producing radio-frequency voltages of such magnitude that a
direct coupling might occur between the cautery tip and the electrode. Induced currents could cause
damage to the cochlear tissues or permanent damage to the implant.
 Diathermy must never be applied over the implant or electrode. High currents induced into the
electrode can cause tissue damage to the cochlea or permanent damage to the implant.
 Diagnostic Ultrasound Energy must not be used in the area of the implant.
 Electroconvulsive therapy must never be used on a cochlear implant patient. Electroconvulsive therapy
may cause tissue damage to the cochlea or permanent damage to the implant.
 Ionizing Radiation Therapy cannot be used directly over the implant as it may damage the device.
 The effects of cobalt treatment and linear acceleration techniques on the implant are unknown.
 Insertion of a cochlear implant electrode will likely result in the loss of any residual hearing in the
implanted ear.
 MRI Safety – MRI information varies between HiRes 90K Advantage and HiRes Ultra. Consult MRI
Safety Information in associated product labeling. MRI is contraindicated when external components
are attached. Labeling states to remove all externals before entering the MR environment.
Precautions
 Electrostatic Discharge (ESD): It is known that static electricity can potentially damage sensitive
electronic components such as the ones used in the cochlear implant system. Care should be taken to
avoid situations in which high levels of static electricity are generated. More information is provided in
the user manuals of the system. If static electricity is present, static electrical potential of the cochlear
implant recipients can safely be reduced by the patients touching any person or object with their fingers
prior to that person or object contacting the implant system.
 Digital Cellular Phones: Using or being in close vicinity to someone using some digital cellular phones
may cause interference with the system. If such interference occurs, patients can turn off the sound
processor or move a greater distance from the phone. Before purchasing a digital cellular phone,
patients should evaluate whether it will interfere with their system. No such interference has been noted
with cellular phones using analog technology.
 Ingestion of Small Parts: The external components of the implant system contain small parts that may
be harmful if swallowed.
 Airport/Security Metal Detectors: Metal detectors, x-ray machines, and security scanners will not
damage the implant or sound processor. However, individuals with a cochlear implant should be
advised that passing through security metal detectors may activate the detector alarm. It is advised that
patients carry their “Patient Emergency Identification Card” with them at all times. Cochlear implant
users also might hear a distorted sound caused by the magnetic field around the security scanner door
or hand-held scanning wand. Turning the sound-processor volume down before passing through
security screening will ensure that those sounds, if they occur, are not too loud or uncomfortable.
 Use of Another Person’s Sound Processor: Implant recipients should use only the sound processor that
has been specifically programmed for them by their clinician. Use of a different sound processor may
be ineffective in providing sound information and may cause physical discomfort.
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 Physical Activity: When engaging in physical activities that include the possibility of trauma or impact,
precautions should be taken, such as wearing a protective helmet, to reduce the risk of damage to the
internal device.
 Change of Performance: If you notice a change of performance with the device, please contact your
caregiver for assessment. If necessary, you can fill out a complaint form and return it to Advanced
Bionics.
Possible Adverse Reactions
Potential adverse reactions that are associated with the HiResolutionTM Bionic Ear System are those typically
associated with surgically implantable materials, which include chronic inflammatory foreign body reaction,
seroma formation, infection potentiation, fistula formation and extrusion.
In addition, the following are the risks associated with cochlear implantation and ear surgery:
 Implant patients incur the normal risks of surgery and general anesthesia
 Major ear surgery may result in numbness, swelling, or discomfort about the ear, disturbance of taste or
balance, or neck pain. If these events occur, they are usually temporary and subside within a few weeks
of surgery.
 Rarely, cochlear implant surgery may cause a leak of inner ear fluid, which may result in meningitis.
 During the surgery, it is a rare possibility that the facial nerve could be injured resulting in a temporary
or permanent weakening or full paralysis on the same side of the face as the implant.
 During the surgery, there is a rare possibility that cerebrospinal fluid leakage or perilymph fluid leakage
could occur.
 As a result of the surgery, it is possible that dizziness, tinnitus, or vertigo may result. If these events
occur, they are usually temporary and subside over time.
 The presence of a foreign body may cause irritation, inflammation, or skin breakdown and may require
additional medical treatment or removal of the internal device.
 Skin infection in the area of the implant may require additional medical treatment or removal of the
internal device.
 There is a possibility that the electrode or device may migrate requiring additional medical treatment or
removal of the internal device to address any resulting injury.
The complete lists of warnings and cautions for the individual Naída products on Cert 022 are included in the
labeling provided in Appendix 2 of the submission.
There are no new warnings or cautions for the Naída products on Cert 022.
Advanced Bionics integrated proven Phonak hearing instrument technology into the Advanced Bionics
Harmony sound processor design to create its first “platform” product line, the Naída CI sound processing
family and accessories (the Platform). The Platform is designed to allow incremental product line extensions to
be added to this foundational technology, e.g., software-based feature upgrades, hardware upgrades and new
accessories, such as the AquaCase approved in the EU in May 2014. The first hardware products in the
Platform, the Naída CI Q70 sound processor and accessories, were approved by TÜV for the EU in 2013, along
with a new software version, SoundWave 2.2, for programming the Naída CI Q70 sound processor. In May
2015, the Electro-Acoustic Stimulation (EAS) system was approved by TÜV for the EU which included the
Naída CI Q90 EAS sound processor and the Naída CI Q90 Acoustic Earhook. With the launch of SoundWave
2.3 in 2015 new front end features for Naída CI Q70 were introduced. In November 2015, the new Naída CI
Q30 and Naída CI Q90 sound processor models were approved by TÜV for the EU, which have different sets
of front end sound processing features enabled. Smaller versions of the approved PowerCels, the PowerCel 110
and 170 Mini, for the Naída platform were approved in March 2016 by TÜV for the EU.
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Past Modifications
Table 10 below summarizes the significant changes during the certification period.
Table 10: Substantial Changes – Products on Cert 022

AB Ref. Date of Date of Short Description TÜV Certificate
Number Submission Approval Reference
CN-2013-01 2013 Jan 2012 New Products for first approval: EC DE I7 13 02 77312
March Naída CI Q70 (CI-5245-xxx) 011
Earhook (CI-5710-xxx)
T-Mic™ 2 (CI-5835-xxx)
RF Cable (CI-5415-xxx)
Zn-Air Battery Pak (CI-5500-xxx)
PowerCel™ 110 (CI-5511-xxx)
Naída CI PowerCel™ Charger (CI-
5605)
AB myPilot (CI-5900-100)
Naída CI Power Adapter (CI-7455-100)
AAA PowerPak™ Accessory (CI-7403)
Power Adapter Cable (CI-7405-xxx)
CN-2013-09 2013 Nov 2014 May New Products for first approval: EC DE I7 13 02 77312
Naída CI AquaCase™ (CI-7431) 011
(1st supplement 2014-
05-09)
CN-2014-06 2014 Oct 2015 Feb UDI labeling change EC DE I7 13 02 77312
011
CN-2015-01 2014 Dec 2015 May New Products for first approval: EC DE I7 13 02 77312
Naída CI Q90 EAS (CI-5250-xxx) 011
Naída CI Q90 Acoustic Earhook (CI- (2st supplement 2015-
5850-xxx) 05-22)
CN-2015-06 2015 Jun 2015 Nov New Products for first approval: EC DE I7 13 02 77312
Naída CI Q30 (CI-5260-xxx) 011
Naída CI Q90 (CI-5280-xxx) (3rd supplement 2015-
11-17)
CN-2015-09 2015 Aug 2015 Oct New front end features available for EC DE I7 13 02 77312
Naída CI Q70 sound processor 011
(WindBlock, SoundRelax, EchoBlock,
and front/back ZoomControl)
CN-2015-10 2015 Nov 2016 Mar New Products for first approval: EC DE I7 13 02 77312
PowerCel™ 110 Mini (CI-5521-xxx) 022
PowerCel™ 170 Mini (CI-5527-xxx)
CE-2017-05- 2017 May NA Acoustic Earhook, labeling update to Pending approval
CN clarify language for global use
Page 32 of 96
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Number of Devices on the market
Table 11 lists the total number of devices shipped, from March 12, 2013 until May 31, 2017.
Table 11: Number of devices shipped
Product Product Name Total Units Shipped
CI-5260-xxx Naída CI Q30 1213

CI-5500-xxx Zn-Air Battery Pak 24573
CI-7403 AAA PowerPak™ Accessory 1248
CI-7455-100 Naída CI Power Adapter 1193
CI-7405-xxx Power Adapter Cable 1885
CI-5605 Naída CI PowerCel™ Charger 47778
CI-5511-xxx PowerCel™ 110
CI-5517-xxx PowerCel™ 170 180691
CI-5523-xxx PowerCel™ 230
CI-5521-xxx PowerCel™ 110 Mini
19107
CI-5527-xxx PowerCel™ 170 Mini
CI-5710-xxx Earhook 16290
CI-5850-xxx Naída CI Q90 Acoustic Earhook 744
CI-5415-xxx RF Cable 228808
CI-5835-xxx T-Mic™ 2 99153
CI-5900-100 AB myPilot 8549
CI-7431 Naída CI AquaCase™ 8679
Device/System modifications
Significant changes implemented during the certification period to the products on Cert 022 are listed in Table
10. In addition, the company decided to obsolete the Cl-5250-xxx Naída CI Q90 EAS processor because this
processor is identical to the Naída CI Q90 processor, CI-5280-xxx. The CI-5250 version was only needed until
EAS was incorporated into the globally distributed version of SoundWave, which was SoundWave 3.0
approved by TÜV in August 2016. The Acoustic Earhook connects and functions in the identical way with the
CI-5280-xxx Naída CI Q90 processor because the hardware and interfaces are the identical. There is no
difference in EAS functionality, indication, patient population or intended use. There is no change to the
original clinical justification for approving the EAS use case. Therefore, there is no impact to the field by
removing this redundant Naída processor model.
New Intended Purposes/Claims/Events that Impact Clinical Evaluation:
There is no new intended purpose/claim/event that impact clinical evaluation. The claims are as described in the
labeling and in Appendix 2 of the submission. Clarification of the Acoustic (EAS) Earhook labeling is
currently in submission with TÜV in CE-2017-05-CN. The changes in wording were intended to consolidate
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labeling, remove redundant information, change the terminology “Naída CI Q90 EAS System”, and clarify the
“Intended Use” and “Indications for Use” statements.
The Intended Use section has been modified to clarify that the acoustic earhook can be used with the Naída CI
Q90 Sound Processor. The section describing the degree of residual hearing was removed and is included in
the “Indications for Use” section (more appropriate). The indications are not affected by this change, as
patients with functional (i.e. aidable) low-frequency residual acoustic hearing are included in the updated
Indications for Use.
The Indications for Use - “in patients who have residual low-frequency hearing sensitivity” was changed to “in
patients with aidable low-frequency hearing sensitivity”. The new wording is intended to clarify indication, as
“aidable” refers to patients likely to benefit from the amplification provided by the acoustic earhook. “Aidable”
includes the original indication of “residual low-frequency hearing sensitivity”. This also consolidates
language, as the previous version described this hearing as “functional” (Intended Use) and “residual”
(Indication). The new terminology is consistent with the previous intention, but intended to be more clear for
the reader.
The remaining content from the indications for use was not actually relevant to indications for use and was
removed from this section and included in more appropriate sections related to the description of the device.
With no change to indication or device function, the expected benefit of the device is unchanged. Clinical
expertise of the audiologist will determine the need and potential benefit for use of amplification with the
acoustic earhook. Clinicians and patients will evaluate benefit in terms of speech understanding and subjective
benefit. In the event that no benefit is observed, the acoustic earhook can simply be removed from the Naída CI
Q90 sound processor for normal operation.
Based on the above there is no impact to clinical evaluation for this labeling change.
IDENTIFICATION OF PERTINENT DATA – STAGE 1
Cochlear implants have been on the market for over 30 years; Advanced Bionics has been producing cochlear
implants for over 20 years. There is extensive literature and public clinical discussion about the use of cochlear
implants. Diverging opinions are presented in several literature reviews conducted according to, or which meet
the review requirements for, MEDDEV 2.7-1 Rev 4. Specifically, different medical options for treatment of
severe to profound hearing loss, EAS and bimodal use are covered in the Indication review. Literature covering
current market use of Advanced Bionics products over the past 24-months is provided in the General Literature
reviews. Topic-specific literature reviews applicable to the Naída products are the Bimodal review and State of
the Art (SOTA) review. All these literature reviews together provide a comprehensive overview of treatment of
hearing loss as well as characterization of Advanced Bionics products in the market. See Section 5.3 for the
literature review conclusions. The complete literature reviews are provided in Appendix 3. The Articles are
provided in Appendix 4.
The Naída products are not intended to address unmet needs, as defined in MEDDEV 2.7-1 Rev 4, Section A8:
for “medical conditions that are life threatening, or cause permanent impairment of a body function, and for
which current medical alternatives are insufficient or carry significant risks.” Cochlear implant technology has
been on the market since 1984 and there are several competitor products as well as Advanced Bionics treating
hearing loss. Hearing loss is not life threatening. The products submitted are also not “breakthrough products”
within the context of this section.
Hazards due to substance/technologies relevant to the device were identified and evaluated per EN ISO
14971:2012. A discussion of the risk analysis is provided in Sections 5.1 and 5.2. Further information related
to the therapeutic/management/diagnostic options, historical context and developments, (dis)advantages of the
Page 34 of 96
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options are discussed in the literature in Section 5. The risk/benefit profiles for target patient populations is
provided in Section 5.
The context of this clinical evaluation is a certificate extension. The Naída products were determined to be meet
the safety and performance requirements of the Essential Requirements of the AIMDD during the certification
and change notice reviews between 2013 and 2015. The products have been on the market for up to 4 years.
Therefore, the assessment will be focused on confirming that the Naída products perform as intended, i.e., that
there are no safety or performance issues which present an unacceptable risk; the literature confirms that the
Naída products provide the clinical benefit of speech understanding. The postmarket data will be evaluated to
ensure that the rate of complaints is acceptable and that there are no adverse events.
There are no design features of the Naída products on Cert 022 that pose special performance or safety issues.
The intended purpose and application of the device (e.g. target treatment group and disease, proposed warnings,
contraindications, precautions, and method of application) are unchanged from the latest approved changes to
Naída products on Cert 022. Some SOTA requirements have been updated since the initial certification and
these data will be addressed in this CER. The information in the literature relating to the medical condition
managed with the device and its natural course, other devices and medical alternatives is included in Section
5.3 and Appendices 3 and 4. The “benchmark” devices are the Naída products themselves; this CER version is
to support re-certification of the Naída products. Therefore, the Scope of the clinical evaluation is intended to
provide confirmatory data that ongoing safety and performance are assured.
The data used in this clinical evaluation were either generated by Advanced Bionics or retrieved from the
literature search. These data will be identified, appraised and analyzed in the next sections of this document.
Data sources to further support safety and performance of the system are summarized in Table 12 below.
Table 12: Identification of Pertinent Data Sources

Type: Year Section
Literature Search General Review – AB Products 2017
from Scientific  2015-2016
Databases  2016-2017 Section 5.3
 Bimodal Appendix 3
 EAS Appendix 4
Therapeutic Options by Indication 2016
State of the Art 2017
Generated and held Bench Data NA Section 4.2.1
by AB Appendix 5
Pre-Clinical Data NA NA
Clinical Data NA Section 4.2.2
Appendix 6
PMCF Studies / Registries NA NA
Complaints Review NA Section 4.2.4
Section 5.2.3
Adverse Event Review NA Section 4.2.5
FSCA / FSN Review NA Section 4.2.6
CAPA Review NA Section 4.2.7
Risk Assessment of the System NA Appendix 7
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The scope of this review is for certification extension for CE-marked devices. A pre-market clinical
investigation is not applicable for a postmarket device. Clinical performance on the Naída products during the
certification period is discussed in risk assessment, postmarket complaint data and the literature. There are no
custom-made device applications for the Naída products. Therefore, the data set does not include these
elements.
The literature search strategy applied for retrieval of information on current knowledge/state of the art,
including sources used, search questions, search terms, selection criteria applied to the output of the search,
quality control measures, results, number and type of literature found to be pertinent, appraisal criteria are
provided in each literature review included in Appendix 3.
The cumulative body of the literature in Appendix 3 and summarized in Section 5 discusses the conditions of
hearing loss, course and consequences of the medical treatment, stages and severities of the conditions. Patient
populations and effects of treatments on these groups are discussed, e.g., age group, gender, time patient has
been without hearing. Historical context is also addressed when germaine. The literature search by indication
covers other treatment options, including advantages and disadvantages of the different options. Risks and
adverse events are also discussed in the literature. Data was reviewed without regard to outcome to include a
comprehensive clinical assessment.
APPRAISAL OF PERTINENT DATA – STAGE 2
This report contains an evaluation of the literature review results and the experience of the products in the
market. The published and unpublished scientific data will demonstrate the continued clinical safety and
clinical performance of the Naída products.
Advanced Bionics performs various aspects of clinical evaluation throughout the lifecycle of its products. AB
has several quality system procedures which provide a methodology for collecting and interpreting its product
lifecycle data. Data outputs from several quality system processes were used, including:
 Risk management, OP2.4.2

 Standard Development Process, OP2.1.20
 Design Verification and Validation, OP2.3.90
 Issue/Complaint Handling Process, D000017065
 Reliability Leadership Team, OP3.7.9
For the literature reviews, MEDDEV 2.7-1 Rev 4 was used; for the 2015-16 general lit review, the assessment
was reviewed based on evaluation criteria in Rev 4. No conclusions would have changed from the prior
assessment to Rev 3 of the MEDDEV.
The clinical expert evaluated the data and supporting documents for this CER and confirmed that the
risk/benefit profile is appropriate, i.e., that the benefit outweighs any residual risk. The clinical evidence
collectively demonstrates that the Naída products perform as intended and meet the Essential Requirements of
the AIMDD that apply to them.
Appraisal plan
Table 13 correlates the quality processes with the outputs used in this CER. Where compliance to the
MEDDEV required additional documents or clinical assessment to be created, the MEDDEV guidance for the
applicable section(s) were used to generate the documents.
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Table 13: Appraisal Plan Summary Table

Method of collection and Outputs of processes
Type:
analysis
Literature General Review – AB Products MEDDEV 2.7-1, Rev 4 Literature reviews
Search  2015-2016
from  2016-2017
Scientific  Bimodal
Databases  EAS
Therapeutic Options by
Indication
State of the Art
Generated Bench Data OP2.1.20 Verification Reports
and held by OP2.3.90 Engineering Reports
AB Clinical Study – FEPs 21 CFR 812 Clinical Study Report
PMCF Studies / Registries MEDDEV 2.7-1 Rev 4 No current PMCF Study or
MEDDEV 2.1.12/2 Rev 2 registry. See Section 5.6 for
PMCF initial proposal.
Complaints Review D000017065 Reliability reporting and
monitoring PMS
Risk Management
Adverse Event Review D000017065 Reliability reporting and
monitoring PMS
Risk Management
FSCA / FSN Review OP6.2.2 NA, no FSCA/FSN
CAPA Review D000018548 Section 4.2.7
Risk Assessment of the System OP2.4.2; EN ISO 14971:2012 RAR0002
MEDDEV 2.7-1 Rev 4, Sect Risk/Benefit Profile
A7.2
Bench Data – Design Verification and Validation
Product testing was performed by Advanced Bionics which assessed safety, functionality, usability, reliability
and biocompatibility. These tests were conducted using SOTA performance and safety standards where
practicable. These data are summarized in Tables 14-16 below.
Documentation that was provided in the previous submissions (Initial certification and Change Notifications)
which are unchanged from the original submissions are not provided in this renewal or CER. Changed/updated
documents are provided in this submission. In Table 14 below, the Submission column will cite this
submission, CE 2017-08-RN, and the Submitted Rev will have a red * showing the revision of the document
being submitted.
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Table 14: Documentation supporting the safety and efficacy of the products on Cert 022
(CI-5260-xxx)
(CI-5245-xxx)
(CI-5280-xxx)
(CI-5500-xxx)
(CI-7455-100)
(CI-7405-xxx)
(CI-5511-xxx)
(CI-5517-xxx)
(CI-5523-xxx)
(CI-5521-xxx)
(CI-5527-xxx)
(CI-5710-xxx)
Naída CI Q90 Acoustic (CI-5850-xxx)
(CI-5415-xxx)
(CI-5835-xxx)
(CI-5900-100)
(CI-7403)
(CI-5605)
(CI-7431)
Product Number
Naída CI PowerCel™
Power Adapter Cable

Zn-Air Battery Pak
AAA PowerPak™
Submitted Rev.
PowerCel™ 110
PowerCel™ 170
PowerCel™ 230
Naída CI Power
Naída CI Q30
Naída CI Q70
Naída CI Q90
Submission
AB myPilot
T-Mic™ 2
RF Cable
Accessory
Earhook
Earhook
Charger
Adapter
Doc # Document Description Aspect Tested
V&V
TESTING
DVeR - Naída Q90 CN 2015- Design Verification
D000013012A (Hardware) 06 A  Performance
X X X
D000009049C DVeR - Pantera SP CN 2015- C  Reliability
System 01  Safety
CN 2013-
Wireless technology:
ER - Evaluation of 01 A
D000009540B X X X  Risk/safety
HiBAN Compliance CE-2017- B*
 Performance
08-RN
ER - HiBAN Wireless CN 2015- Coexistence with
D000009157B X X X X B
Coexistence 01 other wireless devices
D000014564E DVeR - Naída CI Q- CE-2017- E Design verification -
X X X
D000014569F Series Firmware 08-RN F processor
CN 2015-
D000012714F DVeR - Naída CI Q 01 A/- Design verification -
X X X E/F
D000013002E Series UltraZoom CE-2017- *
UltraZoom
08-RN
CN 2015-
DVeR - Naída CI Q90 05 B Design verification –
D000012706G X
auto UltraZoom CE-2017- G* auto UltraZoom
08-RN
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(CI-5260-xxx)
(CI-5245-xxx)
(CI-5280-xxx)
(CI-5500-xxx)
(CI-7455-100)
(CI-7405-xxx)
(CI-5511-xxx)
(CI-5517-xxx)
(CI-5523-xxx)
(CI-5521-xxx)
(CI-5527-xxx)
(CI-5710-xxx)
(CI-5415-xxx)
(CI-5835-xxx)
(CI-5900-100)
(CI-7403)
(CI-5605)
(CI-7431)
Product Number
Power Adapter Cable

Zn-Air Battery Pak
AAA PowerPak™
Submitted Rev.
PowerCel™ 110
PowerCel™ 170
PowerCel™ 230
Naída CI Power
Naída CI Q30
Naída CI Q70
Naída CI Q90
Submission
AB myPilot
T-Mic™ 2
RF Cable
Accessory
Earhook
Earhook
Charger
Adapter
CN 2015-
DVeR - Naída CI Q90 05 B Design verification -
D000012715G X
StereoZoom CE-2017- G* StereoZoom
08-RN
CN 2015-
D000012716G DVeR - Naída CI Q 05 B/- Design verification –
X X X G*/
D000013003E Series F/B Zoom CE-2017- E* front/back Zoom
08-RN
CN 2015-
DVeR - Naída CI Q90 01 A Design verification –
D000013722D X X
Gain Model EAS CE-2017- D* EAS-gain model
08-RN
D000012703F CE-2017- F* / Design verification –
WindBlock DVeR X X
D000012816E 08-RN E* Windblock algorithm
SoundRelax DVeR X X
D000012817E 08-RN E* SoundRelax algorithm
EchoBlock DVeR X X
D000012818E 08-RN E* EchoBlock algorithm
ER - Pantera SP & Acc. CN 2015- Ingress protection –
D000009138A X X X X X X X X X X X X X A
IP54 & IPX7 01 liquid/dust
DVeR - Pantera Zn-Air CN 2015- Design Verification
D000009081A X A
battery 01  Performance
Page 39 of 96
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(CI-5260-xxx)
(CI-5245-xxx)
(CI-5280-xxx)
(CI-5500-xxx)
(CI-7455-100)
(CI-7405-xxx)
(CI-5511-xxx)
(CI-5517-xxx)
(CI-5523-xxx)
(CI-5521-xxx)
(CI-5527-xxx)
(CI-5710-xxx)
(CI-5415-xxx)
(CI-5835-xxx)
(CI-5900-100)
(CI-7403)
(CI-5605)
(CI-7431)
Product Number
Power Adapter Cable

Zn-Air Battery Pak
AAA PowerPak™
Submitted Rev.
PowerCel™ 110
PowerCel™ 170
PowerCel™ 230
Naída CI Power
Naída CI Q30
Naída CI Q70
Naída CI Q90
Submission
AB myPilot
T-Mic™ 2
RF Cable
Accessory
Earhook
Earhook
Charger
Adapter
 Reliability
 Safety
Design Verification
CN 2015-  Performance
D000009008A DVeR - AAA PowerPak X X A
01  Reliability
 Safety
Verify anticipated
ER - AAA PowerPak CN 2015-
D000009005A X X A battery cycle life for
Battery Life Tests 01
specified battery types
Verify anticipated
ER - AAA PowerPak CN 2015-
D000009009A X X A battery pack surface
Surface Temperature 01
temperature
ER - AAA PowerPak IP CN 2015- Ingress protection –
D000009010A X A
54 Testing 01 liquid/dust
Design Verification
D000009084A DVeR – OEPO X A
01  Reliability
 Safety
Design Verification
DVeR – Pantera battery CN 2015-  Performance
D000008913A X A
charger 01  Reliability
 Safety
Page 40 of 96
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(CI-5260-xxx)
(CI-5245-xxx)
(CI-5280-xxx)
(CI-5500-xxx)
(CI-7455-100)
(CI-7405-xxx)
(CI-5511-xxx)
(CI-5517-xxx)
(CI-5523-xxx)
(CI-5521-xxx)
(CI-5527-xxx)
(CI-5710-xxx)
(CI-5415-xxx)
(CI-5835-xxx)
(CI-5900-100)
(CI-7403)
(CI-5605)
(CI-7431)
Product Number
Power Adapter Cable

Zn-Air Battery Pak
AAA PowerPak™
Submitted Rev.
PowerCel™ 110
PowerCel™ 170
PowerCel™ 230
Naída CI Power
Naída CI Q30
Naída CI Q70
Naída CI Q90
Submission
AB myPilot
T-Mic™ 2
RF Cable
Accessory
Earhook
Earhook
Charger
Adapter
Design Verification
DVeR - Pantera Lit-ion CN 2015-  Performance
D000009038C X X X C
batteries (PowerCel) 01  Reliability
 Safety
Design Verification
DVeR - Swiss Lit-ion
D000013120A batteries (PowerCel X X A
06  Reliability
Mini)
 Safety
Design Verification
CN 2015-
D000009082A DVeR - T-Mic/Earhook X X A  Performance
01
 Reliability
Design Verification
DVeR - Naída Q90 EAS CN 2015-  Performance
D000013472A X A
Mech./Elec. 01  Reliability
 Safety
Design Verification
DVeR - Pantera RF CN 2015-
D000008758B X B  Performance
Cable 01
 Reliability
Design Verification
DVeR – MyPilot CN 2015-
D000009087A X A  Performance
(Hardware) 01
 Reliability
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(CI-5517-xxx)
(CI-5523-xxx)
(CI-5521-xxx)
(CI-5527-xxx)
(CI-5710-xxx)
(CI-5415-xxx)
(CI-5835-xxx)
(CI-5900-100)
(CI-7403)
(CI-5605)
(CI-7431)
Product Number
Power Adapter Cable

Zn-Air Battery Pak
AAA PowerPak™
Submitted Rev.
PowerCel™ 110
PowerCel™ 170
PowerCel™ 230
Naída CI Power
Naída CI Q30
Naída CI Q70
Naída CI Q90
Submission
AB myPilot
T-Mic™ 2
RF Cable
Accessory
Earhook
Earhook
Charger
Adapter
Design Verification
DVeR – MyPilot CN 2015-
D000008983C X C  Performance
(Software) 01
 Reliability
Verification labels
ER - Evaluation of Label CN 2013-
D000007984E X X X X X X X X X X X X X X X X X X X E meet 60601-1 SOTA
Indelibility 09
requirement
Design Verification
D000011614A DVeR - AquaCase X A
09  Reliability
 Safety
Verification AquaCase
ER - AquaCase CN 2013- can lock to implant
D000009658A X A
connector performance 09 using various cable
lengths
CN 2013- Ingress protection –
35979-0921447 TR - IP68 Test Report X NA
09 liquid/dust
BIOCOMPAT
IBLITY
CN 2015-
ER - Biol. Eval. for 06 C
D000008158E X X X X X X X X X Biocompatibility
Naída SP CE-2017- E*
08-RN
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(CI-5511-xxx)
(CI-5517-xxx)
(CI-5523-xxx)
(CI-5521-xxx)
(CI-5527-xxx)
(CI-5710-xxx)
(CI-5415-xxx)
(CI-5835-xxx)
(CI-5900-100)
(CI-7403)
(CI-5605)
(CI-7431)
Product Number
Power Adapter Cable

Zn-Air Battery Pak
AAA PowerPak™
Submitted Rev.
PowerCel™ 110
PowerCel™ 170
PowerCel™ 230
Naída CI Power
Naída CI Q30
Naída CI Q70
Naída CI Q90
Submission
AB myPilot
T-Mic™ 2
RF Cable
Accessory
Earhook
Earhook
Charger
Adapter
ER - Biol. Ass. for CN 2015-
D000011931A X X X A Biocompatibility
Cycoloy HC1204HF 06
ER - Biol. Eval. for CN 2015-
D000011969D X X A Biocompatibility
Swiss Batt 10
ER - Biol. Ass. for CN 2015-
D000012065A X X A Biocompatibility
Vectra E130i 10
ER - Biol. Ass. for Swiss CN 2015-
D000012830A X X A Biocompatibility
Batt 10
CN 2015-
ER - Biol. Eval. for 01 B
D000007033D X X X X X X Biocompatibility
Naída accessories CE-2017- D*
08-RN
D000007380B X B Biocompatibility
MyPilot 01
D000008988B X B Biocompatibility
AAA PowerPak 01
D000011834C X C Biocompatibility
Acoustic Earhook 01
D000010489A X A Biocompatibility
AquaCase 09
ER - Biol. Asse. for CN 2013-
Hostaform C9021 09
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(CI-5517-xxx)
(CI-5523-xxx)
(CI-5521-xxx)
(CI-5527-xxx)
(CI-5710-xxx)
(CI-5415-xxx)
(CI-5835-xxx)
(CI-5900-100)
(CI-7403)
(CI-5605)
(CI-7431)
Product Number
Power Adapter Cable

Zn-Air Battery Pak
AAA PowerPak™
Submitted Rev.
PowerCel™ 110
PowerCel™ 170
PowerCel™ 230
Naída CI Power
Naída CI Q30
Naída CI Q70
Naída CI Q90
Submission
AB myPilot
T-Mic™ 2
RF Cable
Accessory
Earhook
Earhook
Charger
Adapter
Hepako Silicone 09
AquaCase and Clip 09
STANDARD COMPLIANCE
SOTA: General
IEC 60601-1 Test CN 2015-
DM1211011 X X X X X X X X X X X X NA electrical safety/
Report 06
performance
SOTA: General
095-1405824/ IEC 60601-1 Test CN 2015-
X X NA electrical safety/
72124051 Report 01
performance
SOTA: General
095-1211011 IEC 60601-1 Test CN 2015-
X X NA electrical safety/
201-72110849 Report 10
performance
SOTA: General
IEC 60601-1 Test CN 2013-
7S045 X NA electrical safety/
Report 01
performance
SOTA: General
IEC 60601-1 Test CN 2013-
DM1307826 X NA electrical safety/
Report 09
performance
IEC 60601-1-2 EMC CE-2017-
ADVB-0034 X X X X X X X NA SOTA: EMC
Test Report 08-RN
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(CI-7405-xxx)
(CI-5511-xxx)
(CI-5517-xxx)
(CI-5523-xxx)
(CI-5521-xxx)
(CI-5527-xxx)
(CI-5710-xxx)
(CI-5415-xxx)
(CI-5835-xxx)
(CI-5900-100)
(CI-7403)
(CI-5605)
(CI-7431)
Product Number
Power Adapter Cable

Zn-Air Battery Pak
AAA PowerPak™
Submitted Rev.
PowerCel™ 110
PowerCel™ 170
PowerCel™ 230
Naída CI Power
Naída CI Q30
Naída CI Q70
Naída CI Q90
Submission
AB myPilot
T-Mic™ 2
RF Cable
Accessory
Earhook
Earhook
Charger
Adapter
SOTA: EMC. NOTE:
Change to SOTA
IEC 60601-1-2 EMC CN 2015-
NA X X NA (2017). Confirmatory
Memo 06
testing scheduled to be
completed Oct 2017.
SOTA: EMC. NOTE:
Change to SOTA
IEC 60601-1-2 EMC CN 2015-
SC1405936 X NA (2017). Confirmatory
Test Report 01
completed Oct 2017.
IEC 60601-1-2 EMC CE-2017- SOTA: EMC
SC1209975 X NA
Test Report 08-RN
SOTA: EMC. NOTE:
Change to SOTA
IEC 60601-1-2 EMC CN 2013-
DM1309733 X NA (2017). Confirmatory
Test Report 09
completed Oct 2017.
EN 60601-1-6 and EN CE-2017-
D000020331A X X X X X X X X X X X X X X X X X X X A* SOTA: Usability
62366 Report 08-RN
SOTA: General
CE-2017-
D000020295A IEC 60601-1-11 Memo X X X X X X X X X X X X X X X X X X X A* electrical safety/
08-RN
performance of home
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(CI-5511-xxx)
(CI-5517-xxx)
(CI-5523-xxx)
(CI-5521-xxx)
(CI-5527-xxx)
(CI-5710-xxx)
(CI-5415-xxx)
(CI-5835-xxx)
(CI-5900-100)
(CI-7403)
(CI-5605)
(CI-7431)
Product Number
Power Adapter Cable

Zn-Air Battery Pak
AAA PowerPak™
Submitted Rev.
PowerCel™ 110
PowerCel™ 170
PowerCel™ 230
Naída CI Power
Naída CI Q30
Naída CI Q70
Naída CI Q90
Submission
AB myPilot
T-Mic™ 2
RF Cable
Accessory
Earhook
Earhook
Charger
Adapter
use products
SOTA: Harmonized
standards for general
safety and
EN 45502-1 and EN CE-2017-
D000020335A X X X X X X X X X X X X X X X X X X X A* performance for
45502-2-3 Report 08-RN
AIMDs; 45502-2-3
SOTA for cochlear
implant systems
SOTA: Harmonized
standards for general
safety and
ER - EN 45502-2-3 - CE-2017-
D000019433A X X X A* performance for
Naida SP 08-RN
AIMDs; 45502-2-3
SOTA for cochlear
implant systems
SOTA:
IEC 60118-13 Test CE-2017-
ADVB0031 X X NA Electroacoustics
Report 08-RN
(hearing aid)
Safety: Li-Ion
BA- batteries. NOTE:
CN 2015-
12CA34504-A- IEC 62133 Test Report X X X NA Change to SOTA
01
1 (2017). Confirmatory
testing will be
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(CI-5511-xxx)
(CI-5517-xxx)
(CI-5523-xxx)
(CI-5521-xxx)
(CI-5527-xxx)
(CI-5710-xxx)
(CI-5415-xxx)
(CI-5835-xxx)
(CI-5900-100)
(CI-7403)
(CI-5605)
(CI-7431)
Product Number
Power Adapter Cable

Zn-Air Battery Pak
AAA PowerPak™
Submitted Rev.
PowerCel™ 110
PowerCel™ 170
PowerCel™ 230
Naída CI Power
Naída CI Q30
Naída CI Q70
Naída CI Q90
Submission
AB myPilot
T-Mic™ 2
RF Cable
Accessory
Earhook
Earhook
Charger
Adapter
available Jan 2018.
Safety: Li-Ion
batteries. NOTE:
CE-2017- Change to SOTA
EA0833 IEC 62133 Test Report X NA
08-RN (2017). Confirmatory
testing will be
available Jan 2018.
Safety: Li-Ion
batteries. NOTE:
CE-2017- Change to SOTA
EA0834 IEC 62133 Test Report X NA
08-RN (2017). Confirmatory
completed Jan 2018.
General Electrical
Safety and
Performance for IT
SI1211747A- IEC 60950-1 Test CN 2013-
X NA and TelCom
000 Report 01
equipment. Normative
reference for
EN60601-1.
* Latest revision of this document is submitted in Appendix 5 of the CER and Annex 06 of the submission.
Page 47 of 96
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New or revised documentation that supports the product safety and efficacy compliance that was not provided
in the previous submissions (Initial certification and Change Notifications) are submitted in Appendix 5 of the
CER. These data are also provided in Annex 06 of the renewal submission and listed in Table 15 below. Where
“SOTA” precedes the explanation in the Reason for Submission or Update/Revision column of Table 15, this
indicates that the purpose of the testing was only to demonstrate compliance to updated SOTA requirements –
not due to design change, complaints or other reasons.
Table 15: New or revised documentation

Doc. Doc. Document
Reason for Submission or Update/Revision
Number Rev. Description
Compliance
SOTA: Memo showing compliance to Amendment 1 of the
Memo A MEMO: IEC
standard.
60601-1 Am1
ER - Naída CI Q-
Series
D000019433 A Compliance to SOTA: Report according EN 45502-1 and EN 45502-2-3
EN 45502-1, EN
45502-2-3
ER - Naída CI
and Accessories
compliance to
D000020335 A SOTA: Report according EN 45502-1: 2015
EN 45502-1
(2015) and EN
45502-2-3 (2010)
TR - Naída CI
Sound Processor
April,
ADVB0034 ICE 60601-1-2 SOTA: Testing according to 4th edition of the standard.
2017
4th Edition
Report
ER - Naída CI
and Accessories
compliance to SOTA: Report according EN 60601-1-6 (2010) and EN 62366
D000020331 A
EN 60601-1-6 (2015)
(2010) and EN
62366 (2015)
ER - Naída CI
and Accessories
D000020295 A compliance to SOTA: Report according IEC 60601-1 11: 2015
IEC 60601-1-11
(2015)
TR - IEC 62133 This functionality was covered under other documentation
Test Report submitted to TUV; however, AB is submitting this document with
Aug,
EA0833 Powercel Mini this application for extension for completeness of the
2014
110 documentation.
TR - IEC 62133 This functionality was covered under other documentation

Test Report submitted to TUV; however, AB is submitting this document with
Aug,
EA0834 Powercel Mini this application for extension for completeness of the
2014
110 documentation.
Page 48 of 96
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Doc. Doc. Document
This functionality was covered under other documentation
Oct, TR - MyPilot submitted to TUV; however, AB is submitting this document with
SC1209975
2012 60601-1-2 Report this application for extension for completeness of the
documentation.
Acoustic Earhook
Jan, 60118-13_4th
ADVB0031 SOTA: Testing according to 4th edition of the standard.
2017 Edition Test
Report
Revision A of this document has been submitted as part of CN
2013-01. The current revision number of this document is B,
which is submitted as part of this renewal submission.
ER - Evaluation
D000009540 B of HiBAN The HIBAN essential performance criteria was missing from the
Compliance document which needs to be defined according to IEC 60601-1-2.
This ER has been updated to include essential performance
criteria, clarified the system description and added an implant
compatibility section.
Revision C of this document has been submitted as part of CN
2015-06. The current revision number of this document is E,
ER – Biological Rev C to D: Minor material and design changes have been

Evaluation for implemented in order to improve the reliability of the Naída Sound
D000008158 E
Naída Sound Processors and Accessories.
Processor
Rev D to E: The report has been updated to correct the material
that is used in the Battery Connector, which has always been
Vectra E130i. Typographical, grammatical, and formatting errors
have been corrected.
Revision B of this document has been submitted as part of CN
2015-01. The current revision number of this document is D,
Rev B to C: Document use of Pebax in earhook, Grivory in

ER – Biological
earhook connector and Grilon in T-Mic 2 connector. Non-patient
Evaluation for
D000007033 D contacting self-tapping screws in the T-Mic 2 were also added to
Naída
support reliability.
Accessories
Rev C to D: The report has been updated to correct patient
contact information for the Locking Pin used in Naída, which does
not have patient contact. Furthermore, typographical, grammatical,
and formatting errors have been corrected.
2015-05. The current revision number of this document is G,
DVeR - Naída CI
D000012706 G Q90 auto
UltraZoom
Rev C to G: Updates to assure that the algorithm work as
expected for newer releases of SoundWave/firmware images.
Page 49 of 96
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Doc. Doc. Document
DVeR - Naída CI submitted to TUV; however, AB is submitting this document with
D000013002 E
Q70 UltraZoom this application for extension for the purpose of completeness of
the documentation.
2015-01. The current revision number of this document is F,
DVeR - Naída CI
D000012714 F Rev A to B: There were no changes in firmware or software.
Q90 UltraZoom
Updating DVeR because the hardware changed.
Rev B to F: Verification of firmware and front end processing

algorithms to support release of newer SoundWave versions.
DVeR - Naída CI which is submitted as part of this renewal submission.
D000012715 G
Q90 StereoZoom
DVeR - Naída CI
D000012716 G Q90 Front/Back
Zoom
DVeR - Naída CI
submitted to TUV; however, AB is submitting this document with
D000013003 E Q70 Front/Back
this application for extension for completeness of the
Zoom
documentation.
2015-01. The current revision number of this document is D,
DVeR - Naída CI
which is submitted as part of this renewal submission. The Naída
D000013722 D Q90 Gain Model
CI Q90 EAS Design Verification Report (D000013722) for the
EAS
Gain Model had been updated upon newer releases of
Soundwave/Palio image (firmware).
DVeR - Naída CI submitted to TUV; however, AB is submitting this document with
D000014564 E
Q70 Firmware this application for extension for completeness of the
documentation.
DVeR - Naída CI
submitted to TUV; however, AB is submitting this document with
D000014569 F Q-Series
this application for extension for completeness of the
Firmware
documentation.
ER – Shipping
Study – Naída CI SOTA: Provide documentation of ongoing compliance with
D000019706 A
sound processor shipping conditions per EN45502-2-3, cl 10.1.
packaging
Page 50 of 96
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During the certification period, there were changes to several standards applicable to the products on Cert 022
or transition periods for compliance which ended. Therefore, AB has conducted the following activities in
Table 16 to demonstrate compliance to these updated SOTA requirements:
Table 16: Changes to SOTA Requirements

Old Standard New Standard Aspect Affected Products Compliance Method Location in
covered Submission
IEC 60601-1- IEC 60601-1- EMC Naída CI Sound Gap assessment NA. Test
2:2007 2:2014 Processors conducted. Emissions report will be
EN 60601-1- T-Mic 2 test requirements did not provided to
2:2015 Power Options change from prior TÜV in a
AquaCase edition. Immunity test supplement,
RF Cable requirements did change upon release
AB MyPilot so products will be of the report.
Naída CI Charger tested to the new
requirements in August
2017.
IEC 60601- EN 60601- General Naída CI Sound Gap assessment Appendix 5
1:2005 1:2006/A1:2013 electrical Processors conducted and document of the CER
EN 60601- IEC 60601- safety and T-Mic 2 in assessment memo. and Annex
1:2006/AC2010 1:2005/A1:2012 performance Power Options Changes to Am 1 were 06 of the
AquaCase administrative or did not submission
RF Cable affect any test conditions
AB MyPilot or compliance of any
Naída CI Charger product on Cert 022
IEC 60601-1- IEC 60601-1- General Naída CI Sound Compliance assessment Appendix 5
11:2010 11:2015 electrical Processors completed and document of the CER
safety and T-Mic 2 in D000020295. and Annex
performance Earhooks 06 of the
– devices Power Options submission
used in home AquaCase
environment RF Cable
AB MyPilot
Naída CI Charger
Acoustic Earhook
IEC 60601-1- IEC Usability Naída CI Sound Compliance assessment Appendix 5
6:2010 62366:2015 Processors completed and document of the CER
EN 60601-1- T-Mic 2 in D000020331. and Annex
6:2010 Earhooks 06 of the
Power Options submission
AquaCase
RF Cable
AB MyPilot
Naída CI Charger
Acoustic Earhook
IEC 60118- IEC 60118- EMC- Acoustic Earhook Test completed and Appendix 5
13:2011 2016 hearing aids Naída CI Q90 reported in ADVB0031 of the CER
sound processor and Annex
06 of the
submission
EN 45502- EN 45502- General Naída CI Sound Compliance assessment Appendix 5
1:1997 1:2015 safety and Processors completed and document of the CER
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Table 16: Changes to SOTA Requirements

Old Standard New Standard Aspect Affected Products Compliance Method Location in
covered Submission
performance T-Mic 2 in D000020331. and Annex
– Active Earhooks 06 of the
Implantable Power Options submission
devices AquaCase
RF Cable
AB MyPilot
Naída CI Charger
Acoustic Earhook
IEC IEC62133- Safety – PowerCel Testing scheduled to be NA. Test
62133:2012 2:2017 LiIon PowerCel Mini completed by Jan 2018. report will be
batteries provided to
TÜV in a
supplement,
upon release
of the report.
Non-inferiority clinical study on front-end sound cleaning features
The study report was originally submitted in CN 2015-05. There have been no changes to these features
which would alter the conclusions of this study.
A non-inferiority clinical study was conducted to demonstrate that there is no negative impact on speech
understanding in quiet and noise when Front-end sound-cleaning features (WindBlock, SoundRelax,
EchoBlock) and beamforming options (auto UltraZoom, StereoZoom) are enabled. Details of the study can be
found in Appendix 6, and are summarized here.
Subjects were 18 experienced adult recipients of CII/HiRes 90K implants (12 unilateral, 6 bilateral). Baseline
AzBio sentence recognition was assessed acutely in quiet and in speech-spectrum noise. Then subjects were
evaluated under the same conditions using each individual feature (WindBlock, SoundRelax, EchoBlock, auto
UltraZoom) and a combination of features (WindBlock + SoundRelax + auto UltraZoom). StereoZoom was
evaluated only in the bilaterally implanted subjects.
Subjects then experienced the features chronically over a four-week period. Using a randomized, blinded cross-
over design, subjects were fit with either a single feature (auto UltraZoom) or a combined feature program
(WindBlock + SoundRelax + auto UltraZoom), each for two weeks. Group A started with the single feature,
and Group B started with the combined feature program. At the end of each two-week period, subjects
completed a questionnaire that assessed their subjective comfort and acceptability of the feature(s).
In both the acute and chronic phases of the study, no software modifications to the subjects’ listening programs
were required for activation and successful use of the sound-cleaning (FEP) and beamforming features.
Statistical analyses showed that sentence understanding in quiet and in speech-spectrum noise with the features
enabled was no worse than in the baseline conditions (non-inferiority margin of 10; WindBlock, SoundRelax,
EchoBlock, auto UltraZoom, combined SoundRelax+WindBlock+auto UltraZoom, non-inferiority p-value <
.0001; StereoZoom, non-inferiority p-value < 0.05). A critical difference score was used to determine whether
individual subjects demonstrate a significant change in performance between the Baseline-Acute scores with
his/her commercial owned sound processor and Naída CI Q90 sound processor. The value for the critical
difference score is based upon the test-retest variance on the AzBio Sentence test. One subject (out of 18) had
worse score difference between post-fitting and baseline testing for AzBio sentence test in noise with the
combined features, however, the single or combined features were acceptable to this subject throughout the
Page 52 of 96
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four-week trial period. Subjects who were dissatisfied with the new FEP features (single or combination)
during the four-week trial period did not show worse AzBio sentence recognition scores with the new front-
end-processing features turned on compared to off.
Questionnaires were administered during both the acute and chronic phases of the study to assess subjects’
qualitative judgments of the sound-cleaning and beamforming features. At the time of acute testing, subjects
were counseled with respect to the intended use of each feature (WindBlock, SoundRelax, EchoBlock, auto
UltraZoom, and StereoZoom for bilateral subjects), evaluated, and then asked via a questionnaire whether each
sound processing feature was acceptable (yes/no) and to rate the favorable aspects of each feature using a
numeric scale from 1-7 (1=Strongly Disagree, 4=Neutral, and 7=Strongly Agree). Subjects used each feature in
a simulated sound environment before completing the questionnaire.
During the chronic phase of the study, the same questionnaire format was used to evaluate subjective
experience with auto UltraZoom alone and with a combined feature program (WindBlock + SoundRelax + auto
UltraZoom). Responses were based upon subjects’ use of the programs in their everyday listening
environments. In the chronic phase, subjects were asked to assess both auto UltraZoom and the combined
features after both two-week periods to maintain blinding of which programs were being activated during each
period.
Acute questionnaires indicated that all individual features were acceptable by all subjects (18/18, 100%).
Chronic questionnaires indicated that auto UltraZoom was acceptable by a majority of subjects (13/18, 72.2%)
and that the combined features (WindBlock + SoundRelax + auto UltraZoom) were acceptable by two thirds of
the subjects (12/18, 66.7%).
Acute ratings were generally favorable for a majority of subjects with median values of 6 or 7 for all questions.
The lowest acute response for any feature was a value of 3. Chronic ratings generally were lower and more
variable but most of the ratings had median values in the positive agreement range. This variability was an
anticipated outcome given the randomized, cross-over blinded study design during the chronic phase. Overall
acceptability shows that there was no added benefit from the combined features compared to the auto
UltraZoom alone.
Only one adverse event was reported. One subject out of 18 (5.6%) experienced skin irritation from the external
sound processor that was resolved. The adverse event was unrelated to the FEP or beamforming features.
In summary, this clinical study demonstrated that use of the front-end sound-cleaning features (WindBlock,
SoundRelax, EchoBlock) and beamforming options (auto UltraZoom, StereoZoom) in the Naída CI processor
does not negatively affect speech understanding in quiet and in noise. Questionnaire results indicated that the
features were acceptable, comfortable, and helpful to a majority of study participants. Modification of listening
programs is not required in order to activate and use the features successfully.
Post Market Clinical Follow-up Studies/Registries
There are currently no active PMCF studies/registries for AB products. Please see Section 5.6.2 for the
proposed PMCF plan. PMCF will be carried out according to the applicable parts of the MEDDEV 2.7-1 Rev 4
and MEDDEV 2.12/2 Rev 2, as part of an overall Postmarket Surveillance monitoring program.
Complaints/Adverse Event Review
All complaints are processed through the same quality system processes for recording, evaluating and resolving
complaints, D000017065. The Issue/Complaint Handling is comprised of 6 phases or sub-processes (see the
Complaint Handling Flow Diagram below):
 Complaint Capture
 Complaint Evaluation, Investigation and Follow Up
 Regulatory Reporting
Page 53 of 96
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 Product Return/ Product Replacement

 Device Failure Analysis
 Complaint Closure
Reported Problem or
Return Product Request
Associated with
Report
RMA Complaint Data Complaint Data
Complaint
Clinical QA
Report Entered Report Entered Management
Transfer Investigation/Follow
into ERP System into RADIUS Evaluation/Follow
Up
Up
Failure Analysis Code

Regulatory Escalation (CAPA,
Reporting/Follow Up SRB, PQRB, etc.)
Receipt of Returned
Failure Analysis
Product
Case Closure
If the complaint is not immediately resolved, additional investigation/follow up is required. Failure Analysis
(FA) is conducted on all returned implants associated with complaints to determine the cause of failure. The FA
results are inputs to the Reliability Leadership Team (RLT), a cross-functional management team including
representatives from engineering, manufacturing, quality systems and regulatory affairs, established to analyze
ongoing trending and reliability data. The function of the RLT is described in OP 3.7.9 Reliability Leadership
Team Process. In addition to trending reliability data, RLT identifies failure modes and corresponding
mechanisms for corrective action, initiates corrective action and tracks progress of corrective actions based on
data obtained through complaint rate, product return rate and explant rate for released products.
The Reliability Leadership Team, on a monthly basis per Quality Procedure, D000007464, will generate the
necessary reliability trend reports to establish a mean complaint/RMA rate for the products. On a monthly
basis, this information is reviewed during the RLT management review meeting. Per operating procedure OP
3.7.9, this meeting is attended by the Head of Operations, Chief Executive Officer, Head of Manufacturing
Engineering, Head of Quality Assurance and Regulatory, and the Head of Quality Systems (or their appointed
alternates). The review includes an assessment of reliability trends and a review of reliability related corrective
actions. On a quarterly basis, this information is reviewed during the Quality Management Review meeting. Per
operating procedure, OP1.1.3 Quality System Review, this meeting is attended by the President, the Head of
Operations, the Head of Regulatory Affairs & Quality Assurance, the Head of Manufacturing & Quality
Engineering, and the Head of Quality Systems.
Adverse Events
There were no Adverse Events occurring globally between March 12, 2013 until May 31, 2017 for any of the
products highlighted in this CER.
Field Safety Corrective Action/Field Safety Notice Review
There were no Field Safety Corrective Actions or Field Safety Notices occurring globally between March 12,
2013 until May 31, 2017 for any of the products highlighted in this CER.
Page 54 of 96
July 31, 2017
CAPA Review
There are 3 CAPAs associated with the products highlighted in this CER. The reason for the CAPA, root cause
analysis and actions taken are provided below in Table 17.
Table 17: Summary of CAPAs for Naída Products on Cert 022

Product
Model
Reason Root cause Action
LL430: Naída The conformal coating Training was conducted to reinforce with
Naída CI Q70
Sound between the battery connector Operators the conformal coating process for the
CI-5245-xxx
Processor and the PCBA flex assembly battery connector and the importance of the
Exceeds is applied manually and the operation.
Allowable operator did not apply a
Temperature sufficient amount of the
Limit conformal coating.
LL364: Overly In describing sound quality The following software enhancements were
Loud issues, there can be differences included in SoundWave version 2.3.23 (Service
Stimulation in terminology used by a Release 2) to mitigate the potential of OLS in
when using the recipient to describe what is some instances: 1. Wolverine Sample Rate
Naída CI Q70 experienced as a loud or Converter update: This software change made
processor overly loud sound/pain. Given improvements to reduce the possibility of a loud
Naída CI Q70
the subjective nature of OLS distortion when switching to a Palio program

CI-5245-xxx
reports from the field, it is not (Beam former program, any sound cleaning
possible to completely features, ComPilot Programs). 2. Bit Toggle
eliminate OLS reports from Bug: A software bug was corrected whereby
the field. However, three the audio payload portion of certain packets was
software improvements were mishandled. This had the potential to result in
identified during the distorted sound being presented to the recipient.
investigation that could 3. OPC Timing: A software improvement was
potentially reduce the made to one of the Wolverine DSP cores to
possibility of OLS incidents. reduce the possibility of distorted sound being
presented during a fitting session.
HL570: Naída Investigation – This CAPA Investigation in-process.
System- was opened on 24May2017
Investigation
Investigation
Inconsistent due to a recent increase in

Battery Life Naída PowerCel complaints
related to inconsistent battery
life from users programmed
with SoundWave 3.0.
Device/System Risk Assessment
Analysis of the available data indicates that the manufacturer has a detailed Risk Management Plan as required
by EN ISO 14971:2012 in accordance with the Risk Management Process OP2.4.2. The Risk Management Plan
identifies the potential safety hazards associated with the device under both normal and fault conditions. The
safety hazard (or risk), the harms associated with the hazard, the severity of the harms, the likeliness of risk
occurrence, mitigation from the risk, and any residual risks are evaluated using a variety of standard risk
analysis methods in compliance with internal operating procedures and recognized standards (EN ISO
14971:2012 Medical Devices – Application of risk management to medical devices). See also Section 5 for
additional discussion about the risk assessment. The Risk Assessment Report is provided in Appendix 7.
Page 55 of 96
July 31, 2017
Custom Made Devices/Compassionate Use/Humanitarian Exemption
Not applicable
Other User Reports
Not applicable
CLINICAL DATA ANALYSIS – STAGE 3
This CER contains a compendium of data, including clinical literature, bench testing, postmarket data and risk
analysis. The analysis of the data is presented in this section in accordance with MEDDEV 2.7-1 Rev 4, Section
A7.1.
The labeling and promotional materials were reviewed and are consistent with the relevant data appraised in
stage 2 of this evaluation. RAR0002 cites when hazards are fully covered by harmonised standards or other
relevant standards.
There are no unacceptable risks associated with the Naída products. The only ALARP residual risks (risk
index of 2) are unchanged from prior clinical assessments. These include risks of choking on small parts of
Naída accessories, strangulation with cables and risk of ComPilot or AB MyPilot interfering with a pacemaker
(wireless coexistence). These risks are mitigated by labeling, test and design mitigations and are reduced as low
as possible within the context of product use and technology.
Risks related to usability were assessed; the Naída products comply with the SOTA standard for externals
usability, EN62366:2015 (see Section 4.2.1) and more generally the EN60601-1 ed 3.1. The RAR0002AL
documents that a usability risk which could diminish performance temporarily (ID 1346) could occur with the
Naída. The original risk, pre-mitigation, was 2 (which is still acceptable and not a safety issue); however, the
residual risk following mitigation in the labeling is 1 – acceptable. RAR0002AL reports hazards added since it
was submitted to TUV (CE-2016-04-RN) which pertain to Naída products. These hazards were assessed with
an original risk index of 2 and then mitigated to a residual risk index of 1 – acceptable. See Appendix 7.
Upon review of Appendix 7, the literature and postmarket data, there are no unanswered/unmitigated questions
which need to be addressed by new clinical data. None of these hazards would change the risk/benefit profile,
i.e., the determination that the Naída products continue to be safe, meet the Essential Requirements and are
suitable for ongoing clinical use. The safety characteristics and intended purpose, including relevant
precautions, are provided in the labeling. The bench data and initial FEP clinical study confirmed the initial
performance and safety of the Naída products. Confirmatory testing conducted to new SOTA requirements
described in Section 4.2.1 demonstrate the Naída products perform per the current SOTA requirements. Where
testing due to changes in SOTA are scheduled or in-process, these data will be provided in a supplement to this
CER and reviewed clinically when available. This testing is for confirmatory purposes only and not due to
safety or performance issues in the field. Safety and performance are further supported by the literature and
postmarket data described in Section 5.2.3. The labeling contains the required information for safe and proper
use of the devices, per the risk assessment reports.
The risk analysis did not yield any issue which would warrant a clinical investigation, i.e., cannot be addressed
through bench data, ongoing postmarket surveillance or the literature. There are no unacceptable risks; risks
have been reduced as far as possible. Based on the literature and postmarket evidence, no new side effects have
been reported or are anticipated. There have been no recalls and no adverse events reported for any Naída
product. No hazards or other clinically relevant issues (e.g. clinical precautions for reduction of risks, clinical
management of risks) remain open.
Page 56 of 96
July 31, 2017
The risk/benefit profile was assessed from a clinical perspective; the analysis determined that there is a positive
benefit/risk ratio for the Naída CI and accessories based on many reviewed data sources:
 Risk assessment (this section (5.1, 5.2); Appendix 7)

 Labeling (this section; Appendix 2)
 Postmarket data (4.2; 5.2.3, Appendix 8)
 Bench data and pre-clinical study report (4.2.1, 4.2.2, Appendix 6)
 Literature (Section 0; Appendix 3)
Risk Assessment
Analysis of the available data indicates that Advanced Bionics has a detailed Risk Management Plan in place,
as required by EN ISO 14971:2012 for regulatory compliance. The detailed risk analysis report is
RAR0002AL. There is one (1) unacceptable Residual Risk associated with the HiResolution Bionic Ear
System, which is related to the implant and not to the Naída products. There are 47 system level ALARP risks,
of which only 2 were applicable to the Naída products. These were discussed in the previous section; they are
addressed by the labeling.
Patient contacting materials are tested for biocompatibility per ISO 10993 requirements and this assists in
managing risks related to material biocompatibility issues. Pre-implant patient counseling regarding outcome
expectations is routinely performed to handle risks involving pain and elective reasons. Surgical and medical
risks are a part of any invasive medical device system and the residual risks have been reduced to as low as
possible within the constraints of technology and reflect the state of the art of medical and surgical practice as it
pertains to cochlear implant surgery.
Five of the six risks associated with the external components have catastrophic severity (S = 5). Their
probabilities have all been reduced to the lowest possible level (P = 1). These risks include choking,
strangulation and electric shock, and are managed primarily by designing parts that require a significant amount
of force for dislodgement that satisfy the SOTA standard, EN60601-1, requirement for electrical safety and via
labeling. These risks have been reduced as low as possible within the constraint of the products’ intended uses.
In addition to labeling as a mitigation of the hazards listed, the following literature was also cited, specifically:
 Arndt et al. Comparison of Pseudobinaural Hearing to Real Binaural Hearing Rehabilitation After
Cochlear Implantation in Patients With Unilateral Deafness and Tinnitus. Otol Neurotol. 2011
Jan;32(1):39-47.
 Firszt et al. Auditory abilities after cochlear implantation in adults with unilateral deafness: a pilot
study. Otol Neurotol. 2012 Oct;33(8):1339-46.
 Amdt et al. Comparison of pseudobinaural hearing to real binaural hearing rehabilitation after cochlear
implantation in patients with unilateral deafness and tinnitus. Otol Neurotol. 2015 Mar;36(3):430-436.
 Bernstein et al. The benefits of cochlear implants for single-sided deafness for sound localization with
multiple concurrent sources. J Acoust Soc Am. 2016 Nov;140(4):3099.
These articles are provided in addition to RAR0002 in Appendix 7.
EN ISO 14971:2012 requires manufacturers to reduce risk as far as possible without regard to economic
considerations. Economic factors were not considered when determining if the risk has been reduced to the
greatest extent possible. All risks have been reduced to the greatest extent possible. The overall residual risk
remains acceptable when weighed against the benefit of providing sound and speech perception to patients with
hearing loss.
Page 57 of 96
July 31, 2017
Based on a comprehensive review of the data in this CER a positive risk/benefit profile is demonstrated.
Analysis of the Labeling
The labeling was reviewed. The labeling correctly describes the intended purpose of the device and description
of functions of each product which was approved in the original submissions. Based on the clinical evidence
provided in this CER, the Naída products continue to perform as intended per the labeling. Information
regarding how to prevent use error, information on residual risks and their management is included. The System
IFU and Acoustic Earhook IFU clearly states the medical conditions and target groups for which conformity
with the relevant Essential Requirements was demonstrated and CE Marking granted.
The proposed clarifications to the Acoustic Earhook IFU in Section 2.8.2 are reasonable from a clinical
perspective because the changes should make the language clearer to the reader and does not change indication
device function, or the expected benefit. The clinical expertise of the audiologist will continue to assess patient
need and potential benefit for use of amplification with the acoustic earhook. Clinicians and patients will
evaluate benefit in terms of speech understanding and subjective benefit. The acoustic earhook does not pose a
safety risk and can simply be removed in the event no benefit is observed. Electric stimulation with the Naída
CI Q90 sound processor can be continued, as the Naída does not require the acoustic earhook for its function.
Postmarket Complaint Data
Product complaints (normalized over a rolling 3-month period) during the certification period of Cert 022 were
assessed. Reliability updates were incorporated into the Naída connector and battery interfaces on Naída CI
Q70 (which were carried over into the Q30 and Q90 processors). Reliability updates were also made to the RF
cable, earhook and T-Mic 2. These were described in change notices CN 2015-06 and CN 2015-09 and/or were
also described to TÜV during annual surveillance audits as insubstantial changes. None of these updates
changed intended use, clinical indication, patient interface with the product, performance specification or
function, or risk profile. Therefore, there was no impact on the clinical evaluation of the products and no
change in conformity to Essential Requirements. Following these changes in late 2015 the complaint rate for
the Naída CI Q70 dropped by ~50%. As of May 30, 2017, the Naída CI Q70 processor RMA Complaint Rate
remains between 4 and 5% (y axis highlighted by red square for Q30). The remaining product RMA complaint
rates ranged from less than 1% to 3%. See Table 18. The data trends indicate that for all products the complaint
rates are stable and the performance is acceptable.
Table 18: RMA Complaint Data – Naída Products (March 2013 until May 31, 2017)
Product Total RMA
Complaint Rate
Number Units Complaint Top 10 Findings
(Normalized RMA Rate)
Name Shipped Number
 Broken traces or Flex on the main
PCBA
 Toggle switch or knob broken
 Device test failure
 Naída turns off by itself
CI-5260-xxx  No communication with CPI
1213 30
Naída CI Q30  Intermittent communications
 Contamination
 Failed Functional Test
 No link
 Processor with Error Log Entry –
Any Error Type
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July 31, 2017
Product Total RMA
Complaint Rate
Name Shipped Number
 Broken Naída Battery socket due to
corrosion
RMA Complaint Rate Naida CI Q70
 Processor with Error Log Entry – # RMAs for Complaints
Any Error Type Return Rate

3 per. Mov. Avg. (Return Rate)
Normalized RMA Rate

No Problem Found 1600 10.00%
# RMA Complaint
1400 9.00%
CI-5245-xxx  Unknown battery- Error Log type 1200

1000
8.00%
7.00%
6.00%
73540 37236  Old Earhook connector broken and 800
600
5.00%
4.00%
Naída CI Q70 stuck in Naída 400 3.00%
2.00%
200

1.00%
RF contact pin damaged 0 0.00%
2013_03
2013_08
2014_01
2014_06
2014_11
2015_04
2015_09
2016_02
2016_07
2016_12
2017_05
 Connector broken
 No communication with CPI
 Contamination
 Linking intermittent
 Processor with Error Log Entry –
Any Error Type RMA Complaint Rate Naida CI Q90
 No Problem Found # RMAs for Complaints

Return Rate
 No communication with CPI 3 per. Mov. Avg. (Return Rate)
Normalized RMA Rate

350 3.00%

# RMA Complaint
Linking intermittent 300 2.50%
250
CI-5280-xxx  RF contact pin damaged 200
2.00%
20433 2675 1.50%
Naída CI Q90  Connector broken 150

100 1.00%
 Acoustic test failure 50

0
0.50%
0.00%
 Naída – FT Amp Buf underflow –
2013_03
2013_08
2014_01
2014_06
2014_11
2015_04
2015_09
2016_02
2016_07
2016_12
2017_05
Error Log type
 Toggle switch or knob broken
 Unknown battery- Error Log type
 No Problem Found
 Battery contact or pin damaged RMA Complaint Rate Zn-Air Battery Pak
 Housing broken or cracked # RMAs for Complaints

Return Rate
 Battery latch malfunction 3 per. Mov. Avg. (Return Rate)
Normalized RMA Rate

140 2.50%

# RMA Complaint
CI-5500-xxx Missing spring on Zn-Air battery 120

100
2.00%
pak 80 1.50%
Zn-Air Battery 24573 2232
 Connector broken 60
40
1.00%
Pak  Zn-Air cells were installed 20

0.50%
0 0.00%
backwards into the battery
2013_03
2013_08
2014_01
2014_06
2014_11
2015_04
2015_09
2016_02
2016_07
2016_12
2017_05
Cartridge
 Device test failure
 Battery latch broken/cracked
RMA Complaint Rate AAA PowerPak
# RMAs for Complaints
Return Rate
Normalized RMA Rate
9 1.80%
CI-7403
# RMA Complaint
8 1.60%
7 1.40%
 6 1.20%
AAA Failed Functional Test 5 1.00%
1248 89 0.80%

4 0.60%
PowerPak™ No Problem Found 3 0.40%
2 0.20%
Accessory 1
0
0.00%
-0.20%
2013_03
2013_08
2014_01
2014_06
2014_11
2015_04
2015_09
2016_02
2016_07
2016_12
2017_05
RMA Complaint Rate Naída CI Power Adapter

Return Rate
Normalized RMA Rate
10 1.60%

# RMA Complaint
9
CI-7455-100 No Problem Found 8
1.40%
1.20%

7
Contamination 6 1.00%
1193 82 5 0.80%
Naída CI Power  Failed Functional Test 4
3
0.60%
0.40%
Adapter  Circuits open or shorted
2
1 0.20%
0 0.00%
2013_03
2013_08
2014_01
2014_06
2014_11
2015_04
2015_09
2016_02
2016_07
2016_12
2017_05
Page 59 of 96
July 31, 2017
Product Total RMA
Complaint Rate
Name Shipped Number
RMA Complaint Rate Naida Power Adapter Cable
Return Rate
Normalized RMA Rate

20 1.80%

# RMA Complaint
18 1.60%
CI-7405-xxx Damaged Insulation on cable or 16 1.40%
14 1.20%
wire 12 1.00%
1885 127 10
Power Adapter  No Problem Found 8
6
0.80%
0.60%
Cable  Circuits open or shorted
4
2
0.40%
0.20%
0 0.00%
2013_03
2013_08
2014_01
2014_06
2014_11
2015_04
2015_09
2016_02
2016_07
2016_12
2017_05
RMA Complaint Rate Naída PowerCel Charger
 Contamination # RMAs for Complaints
 Connector broken Return Rate

Normalized RMA Rate

CI-5605 Device test failure 300 1.80%
# RMA Complaint
1.60%
250
 Battery contact or pin damaged 200
1.40%
1.20%
Naída CI 
1.00%
47778 5378 Failed Functional Test 150
0.80%
PowerCel™  Component corroded/oxidized
100 0.60%
0.40%
50
Charger  LED not working or flashing 0
0.20%
0.00%
2013_03
2013_08
2014_01
2014_06
2014_11
2015_04
2015_09
2016_02
2016_07
2016_12
2017_05
abnormally
 Circuits open or shorted
 Intermittent Operation
CI-5511-xxx RMA Complaint Rate Naida PowerCel
 Connector broken # RMAs for Complaints
PowerCel™ 110  Naída SP connector pin broken off Return Rate

Normalized RMA Rate

and stuck in battery connector. 1600 3.50%
# RMA Complaint
1400 3.00%
CI-5517-xxx  Battery voltage OOT 1200

1000
2.50%

2.00%
180691 27445 Contamination 800
1.50%
PowerCel™ 170  Battery IR OOT
600
400 1.00%
200 0.50%
 Housing broken or cracked 0 0.00%
2013_03
2013_08
2014_01
2014_06
2014_11
2015_04
2015_09
2016_02
2016_07
2016_12
2017_05
CI-5523-xxx  Circuits open or shorted
PowerCel™ 230  Component corroded/oxidized
 Battery contact or pin damaged
CI-5521-xxx  Connector broken RMA Complaint Rate Naida Mini PowerCel
 Device test failure # RMAs for Complaints
PowerCel™ 110  Battery voltage OOT

Return Rate
Normalized RMA Rate

160 1.00%
Mini 
# RMA Complaint
140 0.90%
Battery IR OOT 120 0.80%
0.70%
 Battery; broken rails 100 0.60%
19107 913 80 0.50%
 Naída SP connector pin broken off 60
40
0.40%
0.30%
0.20%
CI-5527-xxx and stuck in battery connector. 20
0
0.10%
0.00%
 Battery contact or pin damaged
2013_03
2013_08
2014_01
2014_06
2014_11
2015_04
2015_09
2016_02
2016_07
2016_12
2017_05
PowerCel™ 170  Damaged Insulation on cable or

Mini wire
 Housing broken or cracked
RMA Complaint Rate Naida CI Q70 Earhook
 Connector separates from Earhook Return Rate

Normalized RMA Rate
Housing broken or cracked 160 2.50%

# RMA Complaint
140
CI-5710-xxx  Connector broken 120

100
2.00%
1.50%
16290 2232  No Problem Found 80
60 1.00%
Earhook  Broken wires 40 0.50%
20
 Cable broken away from connector 0 0.00%
2013_03
2013_08
2014_01
2014_06
2014_11
2015_04
2015_09
2016_02
2016_07
2016_12
2017_05
Page 60 of 96
July 31, 2017
Product Total RMA
Complaint Rate
Name Shipped Number
RMA Complaint Rate Naida EAS Earhook
Return Rate
Normalized RMA Rate

4.5 0.80%
CI-5850-xxx
# RMA Complaint
4 0.70%
3.5 0.60%
Naída CI Q90  None Analyzed Yet; complaint rate 3

2.5
0.50%
744 37 2
0.40%
Acoustic less than 1% 1.5 0.30%

0.20%
1
0.10%
Earhook 0.5
0 0.00%
2013_03
2013_08
2014_01
2014_06
2014_11
2015_04
2015_09
2016_02
2016_07
2016_12
2017_05
 Cable broken away from connector
 No Problem Found RMA Complaint Rate Naida CI Q70 RF Cable
 Circuits open or shorted # RMAs for Complaints

Return Rate
 Broken wires 3 per. Mov. Avg. (Return Rate)
Normalized RMA Rate

3500 6.00%

# RMA Complaint
Center contact broken in coax 3000
2500
5.00%
CI-5415-xxx connector 2000
4.00%
228808 69728 3.00%
RF Cable  Connector broken 1500

1000 2.00%
 Contamination 500
0
1.00%
0.00%
 Damaged Insulation on cable or
2013_03
2013_07
2013_11
2014_03
2014_07
2014_11
2015_03
2015_07
2015_11
2016_03
2016_07
2016_11
2017_03
wire
 Bite marks
 Case Separation
 Connector separates from Earhook
 Broken wires RMA Complaint Rate T-Mic™ 2
 No Problem Found # RMAs for Complaints

Return Rate
 Failed Functional Test 3 per. Mov. Avg. (Return Rate)
Normalized RMA Rate

1400 6.00%

# RMA Complaint
T-Mic EH to cable transition open 1200

1000
5.00%
CI-5835-xxx  Acoustic test failure 800
4.00%
99153 22176 3.00%

600
T-Mic™ 2 Microphone Housing Cap not 400 2.00%
1.00%
returned 200
0 0.00%
 Connector broken
2013_03
2013_08
2014_01
2014_06
2014_11
2015_04
2015_09
2016_02
2016_07
2016_12
2017_05
 Damaged Insulation on cable or
wire
 Contamination
RMA Complaint Rate myPilot
Return Rate
Normalized RMA Rate
50 3.50%
# RMA Complaint
45 3.00%
CI-5900-100  No Problem Found 40

35 2.50%
30

2.00%
8549 1066 Housing broken or cracked 25
20 1.50%
AB myPilot  Failed Functional Test 15
10
1.00%
5 0.50%
0 0.00%
2013_03
2013_08
2014_01
2014_06
2014_11
2015_04
2015_09
2016_02
2016_07
2016_12
2017_05
RMA Complaint Rate Naida CI AquaCase

 Connector broken # RMAs for Complaints
 No Problem Found Return Rate

Normalized RMA Rate
Contamination 35 1.60%
# RMA Complaint
30 1.40%
CI-7431  Gross leak test failure 25 1.20%
1.00%

20
Naída CI 8679 349 Circuits open or shorted 15
0.80%
0.60%
AquaCase™  Center contact broken in coax 10

5
0.40%
0.20%
connector 0 0.00%
2013_03
2013_08
2014_01
2014_06
2014_11
2015_04
2015_09
2016_02
2016_07
2016_12
2017_05
 Component corroded/oxidized
Page 61 of 96
July 31, 2017
Key Conclusions from the Literature to Support Positive Risk/Benefit Profile
5.2.4.1 State of the Art – Naída CI processors
This review found speech perception in quiet data from 77 CI patients wearing Naída CI sound processors in
the published literature. None of these reports suggested any safety or efficacy issues related to the use of a
Naída CI sound processor. A variety of tests were administered to obtain speech perception in quiet measures,
therefore the results cannot be compared across studies. However, all studies described clinical benefit to
speech perception in quiet when using a Naída sound processor. When studies included individual data from
patients wearing different sound processors, clinically insignificant differences were seen between average
scores overall and of Naída users only. This review supports the distinction of the Naída CI sound processors
as “state of the art.”
5.2.4.2 Evaluations of Advanced Bionics devices
A survey study gathered data from both implant recipients and professionals on the ease of use, usefulness of
the new functions and features, and fitting practices regarding the Naída CI Q70 (Naída CI) sound processor
(Martin et al., 2016). A comprehensive user satisfaction survey was conducted in a total of 186 subjects from
24 centers. In parallel, 23 professional questionnaires were collected from 11 centers. Overall, there was high
satisfaction with the Naída CI processor from adults, children, experienced and new CI users as well as from
professionals. The Naída CI processor was shown as being easy to use by all ages of recipients and by
professionals. The majority of experienced CI users rated the Naída CI processor as being similar to or better
than their previous processor in all areas surveyed. The Naída CI was recommended by the professionals for
fitting in all populations. Positive ratings were obtained for ease of use, comfort and usefulness of the new
functions and features of the Naída CI sound processor. Seventy-seven percent of the experienced CI users
rated the new processor as being better than their previous sound processor from a general point of view. The
survey also showed that fitting practices were influenced by the age of the user. For example, features like
UltraZoom, ZoomControl and DuoPhone would not be fitted to very young children but would be fitted to
adults.
5.2.4.3 Data demonstrated by General Lit Reviews
The literature continues to show that cochlear implantation is safe and effective. The safety of cochlear
implantation was upheld in the papers published in 2016-17. No new safety concerns were uncovered in this
review; all issues have been previously reported. No complication was found to be more prevalent than
previously reported. Speech perception in quiet and in noise is significantly improved by CI in children and
adults, and in various device configurations (unilateral CI, bilateral CI, bimodal CI, EAS). Most patients also
experience an improved quality of life and are satisfied with their CI. Much research continues to be done on
the effect of various factors on CI outcomes. For patients meeting CI candidacy requirements, the benefits of
cochlear implantation outweigh the risks.
Any study including data from one or more Advanced Bionics devices was reviewed, graded and summarized.
No result-based exclusions were made; therefore, the report is not biased towards better outcomes. Research
into the safety and efficacy of cochlear implants continues to flourish. The reviewed studies cover a wide array
of topics, ranging from the perception of speech and music through a cochlear implant to the degree of residual
acoustic hearing retained after implantation. Perceptual outcomes are variable, and much research continues to
evaluate the factors contributing to this variability in order to better predict which patients would be best served
by a cochlear implant. Researchers and clinicians continue to improve implant design, surgical techniques,
sound processing algorithms and auditory rehabilitation programs to further improve the safety and efficacy of
cochlear implants. The literature clearly demonstrates that cochlear implantation continues to be a relatively
safe procedure for both children and adults that provides significant benefit to patients who receive inadequate
audibility from hearing aids.
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Naída CI Sound Processors – State of the Art
5.3.1.1 General Information
This review addresses the state of the art for Naída CI sound processors. Because the ability to understand
speech is the fundamental goal of cochlear implantation, the endpoint of speech perception in quiet was used as
an indicator for state of the art. All published literature containing speech perception in quiet data from patients
using the Naída CI sound processor was reviewed. Published data of patients using a Naída CI Q30, Q70 or
Q90 EAS were sought. The processor models worn by study participants are often not included in the fields
searched by the online database search software, and only two relevant studies were discovered in the database
search. Therefore, a search was performed in the author’s reference manager library that searched all fields
plus the text of pdf attachments for the term “Naída.” This search uncovered eight additional relevant studies.
In four of the included studies, representing 42 patients, all included patients wore Naída CI Q70 sound
processors (DeCeulaer et al., 2016; Devocht et al., 2016; van Loon et al., 2017; Wolfe et al., 2015). The other
six studies included patients wearing a variety of sound processors including Naída (Bosen et al., 2016;
Cullington et al., 2017; Meeuws et al., 2017; Neuman et al., 2017; Polat et al., 2016; Sjoberg et al., 2017).
As can be seen in the table above listing the number and model of Naída CIs included in each study, only data
from Naída CI Q70 models were found. In one instance representing three patients, the model of the Naída CI
sound processor was not specified. The Naída CI Q30, Q70 and Q90 models are considered clinically
equivalent. They share the same hardware and are differentiated only by optional features activated at the
discretion of a clinician. These features are mainly bilateral enhancements and comfort features. The Q90
model can also be used with an acoustic earhook for electro-acoustic stimulation. None of these optional
features are required for the medical treatment of hearing loss, and none change the baseline performance of the
Naída CI sound processor for understanding speech in quiet. A thorough description of these features and
which features are available on specific Naída models is included in the body of the CER. Because the three
Naída models are clinically equivalent, speech perception data obtained with the Naída Q70 is applicable to the
Q30 and Q90 models as well.
5.3.1.2 Risk of bias assessment
Risk of bias was assessed for each study, and a summary table of these assessments is included above. Low
risk of performance, detection, attrition and performing bias was seen across all studies. The risk of selection
bias was also low across studies, although one of the studies including outcomes from multiple types of sound
processors (one Naída patient) did not clearly state their inclusion and exclusion criteria, making their risk of
selection bias unclear (Sjoberg et al., 2017).
5.3.1.3 Speech perception in quiet: Monosyllabic words
Speech perception in quiet was measured in all reviewed studies, however it was not the main outcome measure
in any. A variety of tests were used to assess this outcome, contributing to the variability in scores across
studies, with average scores ranging from 64% to 93% correct. Four studies used tests of monosyllabic word
perception. In a study of beamforming in bimodal Naída CI users, twelve patients assessed with the consonant-
nucleus-consonant (CNC words) test presented at levels up to 75 dB SPL averaged 74.5% correct when
listening with the CI alone, and 81.5% correct when listening bimodally (Devocht et al., 2016). This study
required a score of at least 50% correct on CNC words when listening bimodally as part of its inclusion criteria.
Another study focusing on outcomes of patients initially fit bimodally who did or did not continue to wear a
contralateral hearing aid (HA) also used the CNC words test to assess speech perception in quiet (Neuman et
al.,2017). Out of 94 patients who initially used bimodal stimulation, 80 continued HA use and 14 discontinued
HA use. These groups were analyzed separately. When listening with the CI only, there was no significant
difference in speech perception scores between the two groups (65% vs. 64% correct). However, when
listening bimodally, the group continuing HA use had a significant improvement over the CI alone (72%
correct) whereas the group who did not continue HA use had no change in their score (64% correct).
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Therefore, in this study, scores on the CNC words tests ranged from 64% to 72% correct depending on the
group and listening condition.
Speech perception in quiet was assessed using speech audiometry open set monosyllables (Flemish
monosyllable word in quiet test) at 40, 55, 70, and 85 dB SPL in quiet in 25 adult CI patients before analyzing
their CI fitting with the fitting software algorithm FOX (‘Fitting to Outcome eXpert’) (Meeuws et al., 2017).
Fitting changes were suggested and implemented in 21 patients, including 9 Naída users, and their speech
perception was retested in the same session. Statistically significant improvement was evident in 19/21
participants. Neither of the two remaining patients wore Naída sound processors. The average percent correct
score of the Naída users (72.6%) was similar to that of the entire cohort (75.6%).
Seven adult patients with asymmetric hearing loss (AHL) were implanted with AB devices in their worse
hearing ear, and speech perception in quiet was assessed with the consonant-vowel-consonant (CVC) words test
presented at 65 dB SPL (van Loon et al., 2017). All used Naída sound processors. Before implantation, they
were unable to perceive speech in the worse ear (0% correct) but on average achieved 74% correct speech
perception in quiet using a hearing aid in the better ear. A year after implantation, speech perception in quiet
improved to an average of 75% in the implanted ear and 88% correct when listening bimodally.
5.3.1.4 Speech perception in quiet: Sentences
Six studies assessed speech perception in quiet with sentence-based tests, with all studies using a different test.
Two of these studies included only Naída CI users with the main endpoint being the perception of speech in
noise with the Roger Pen accessory (de Ceulaer et al., 2016; Wolfe et al., 2015). Patients performed well on
these tests, with 12 patients averaging 93.4% correct on the Flemish sentences in noise test (noise absent
condition) (De Ceulaer et al., 2016) and 11 patients averaging 84% correct on the AzBio sentences test (Wolfe
et al., 2015). The IEEE sentences test was administered to ten CI patients in a study assessing the relative
importance of particular frequency bands to speech perception (Bosen et al., 2016). When all frequency bands
were present, the average performance was 76.9% correct. The three patients wearing Naída sound processors
produced similar scores to the rest of the group, averaging 77.5% correct.
Three studies included patients wearing Naída sound processors but either did not provide individual data, or
did not label the presented individual data by subject, so that performance with the Naída sound processor could
not be compared to that of other sound processors. A study testing a novel speech in noise test included
performance on the BKB sentences tests presented at 70 dB SPL (Cullington et al., 2017). Sixteen patients
averaged 80% correct, with three of the patients wearing Naída sound processors. A study focusing on CI
children’s musical timbre and pitch perception, along with talker discrimination ability, included performance
on the Multimodal Lexical Sentence Test for Children (MLST-C) presented at 60 dBC SPL (Sjoberg et al.,
2017).
Thirty children averaged 77.2% correct on this test, with one participant wearing a Naída sound processor. And
finally, a study of speech perception in quiet and in noise of Turkish adult CI patients administered the Turkish
Matrix Test (Polat et al, 2016). The thirty patients in that study achieved an average speech reception threshold
of 44 dB SPL in that test. Their non-adaptive intelligibility score in quiet averaged 91.1% correct. Five patients
in that group wore Naída sound processors.
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General Lit Review – 2015-2017
5.3.2.1 Background
This document is a general review of topics related to Advanced Bionics cochlear implants. It includes annual
reviews of all studies relating to the safety and efficacy of Advanced Bionics products, as well as more focused
reviews on relevant topics:
General Literature Review (2016-2017)

General Literature Review (2015-2016)
Update to EAS outcomes review
Bimodal listening: Cochlear implant with contralateral
hearing aid
The two general literature reviews cover a wide array of topics presented in the cochlear implant literature, with
a focus on the safety and efficacy of Advanced Bionics devices. They include all papers with safety or efficacy
data from at least one patient using Advanced Bionics devices, with some papers including only Advanced
Bionics patients and others including devices from multiple manufacturers. Reviews from both time periods
conclude that Advanced Bionics cochlear implants remain safe and effective for the treatment of severe to
profound sensorineural deafness. The other reviews on specific topics include all relevant literature regardless
of CI manufacturer.
5.3.2.2 General assessment of studies – 2016-2017
One hundred twelve (112) relevant studies were discovered in this search. All have been graded, weighted, and
assessed for risk of bias (included with abstracts and summarized in table above). In terms of relevance to the
review, 6 of the assessed papers were considered “Crucial,” 42 “Important,” 32 “Supportive” and 33
“Peripheral.” Eighty-eight studies (78%) were clinically relevant. The majority of studies included adults, and
children were represented either alone or with adults in 40 studies (35%). Risk of bias was generally low (see
table above). Eight studies had a high risk of selection bias. Six of these were case studies or small case series
and were deemed high risk because the included patient(s) may not be representative of the CI population as a
whole. Another study did not describe exclusion criteria and the groups had multiple confounds, and the last
was unclear on the number of patients included, with the total inclusion number changing throughout the report.
Twenty-one studies had an unclear risk of selection bias, with 18 due to insufficient description of the inclusion
and/or exclusion criteria. The remaining 3 were questionnaire studies, in which it was not possible to know if
the patients that did not return the questionnaire would have responded differently than those who did return it.
All studies had low performance and detection bias. Two studies had an unclear risk of attrition bias. One of
these studies was unclear in reporting the total number of patients, making it unclear if there were any missing
data. In the other paper, many patients did not have data from the main follow-up timepoint of 6 months due to
the combination of retrospective and prospective data, and it was unclear if the results would change if that data
had been documented. Three studies had a high risk of reporting bias. In two of these studies it was unclear
whether all relevant cases were reported due to changing numbers in the reports, and the other mentioned a
group of patients in the abstract and discussion that was not described in the methods.
Of particular interest for this report, twenty-six new studies included only patients wearing Advanced Bionics
implants, (Aronoff et al., 2016; Devocht et al., 2016; Dyballa et al., 2016; Gazibegovic and Bero, 2016; Hilly et
al., 2016; Kamakura and Nadol, 2016a; Kraaijenga et al., 2016; Luo and Wu, 2016; Martin et al., 2016; Svrakic
et al., 2016; Taal et al., 2016; Todt et al., 2016; van der Jagt et al., 2016; van Zon et al., 2016; Avci et al., 2017;
Benghalem et al., 2017; Finke et al., 2017a; Koka et al., 2017; Kraaijenga et al., 2017; Kreft and Oxenham,
2017; Langner et al., 2017; Nogueira et al., 2017; Padilla et al., 2017; Sharma et al., 2017; van Loon et al.,
2017; Vellinga et al., 2017) and another eight studies included 50% or more Advanced Bionics devices (Anand
et al., 2016; Bosen and Chatterjee, 2016; Crew et al., 2016; Hughes et al., 2016; Nemer et al., 2016; Alyono et
al., 2017; Duchesne et al., 2017; Ishai et al., 2017).
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5.3.2.3 Safety and Efficacy of CI
The literature published over the past twelve months confirms previous reviews finding cochlear implantation
(CI) to be safe and effective in patients with a wide variety of demographics, including all ages, and using a
variety of device configurations. A multitude of studies reviewed below show that CI allows deaf patients to
understand speech, and that the benefits outweigh the risks of CI surgery. CI has been shown to significantly
improve perceived quality of life for patients of all ages and with various CI configurations (Aimoni et al.,
2016; le Roux et al., 2016; Liu et al., 2016; Sladen et al., 2016; Finke et al., 2017b; van Loon et al., 2017).
Perception of tonal language is also improved with CI in children and adults (Chen et al., 2016; Liu et al., 2016;
Li et al., 2017; Peng et al., 2017; Yang and Zeng, 2017).
Efficacy Studies
5.3.3.1 CI in children and the elderly
The literature continues to show that children achieve substantial gains in speech perception with a CI (Mancini
et al., 2016; Nelson et al., 2016; Sladen et al., 2016; Silva et al., 2017; Sladen et al., 2017; Taitelbaum-Swead
and Fostick, 2017; Thomas et al., 2017), including children who speak tonal languages (Chen et al., 2016; Liu
et al., 2016; Li et al., 2017). Various stimuli and device configurations were used in making these assessments.
Binaural hearing was shown to provide significant benefit to both bilaterally implanted and bimodal children
(Choi et al., 2017; Reeder et al., 2017; Yang and Zeng, 2017). Pediatric CI patients are able to discriminate
spectral ripples as well as adult CI patients (Horn et al., 2017). Prelingually deafened patients who did not
receive a CI until adolescence or adulthood also received significant subjective benefit from the CI in most
cases despite the long duration of deafness including the critical period for language learning in childhood
(Duchesne et al., 2017).
Significant improvements in speech perception and quality of life were also confirmed for the use of CI in
elderly deaf patients (Aimoni et al., 2016; Ghiselli et al., 2016; Lee et al., 2017; Tang et al., 2017). However,
some studies find a larger benefit in younger adults (Aimoni et al., 2016; Lee et al., 2017), with one study
finding that improvements in speech perception took longer to plateau in elderly patients (Ghiselli et al., 2016).
Post-surgical complications were found to be similar in older and younger adult CI patients (Lee et al., 2017).
All studies that included elderly patients agreed that implantation of elderly deaf subjects is safe and effective.
5.3.3.2 Bilateral CI and bimodal stimulation
Studies testing patients with bilateral CI found significant benefits to speech perception in quiet and in noise in
both children and adults (van Zon et al., 2016; Finke et al., 2017c; Lim, 2017; Ohta et al., 2017; Reeder et al.,
2017). In a rare randomized controlled study, 38 postlingually deafened adult CI candidates were randomized
to receive bilateral CIs (biCI) either in one surgery (simultaneous) or with an interval of up to two years
between implantations (sequential) (Kraaijenga et al., 2017). Nineteen patients were randomized into each
group and all received HiRes 90K implants with Harmony sound processors. Three of the sequential biCI
patients were lost to follow-up before their second implantation with at least two due to satisfaction with the
unilateral CI. Speech perception in quiet and in noise, sound localization, subjective hearing assessments and
quality of life measures were compared between groups. Data from one year after simultaneous implantation
were compared to data from one year after sequentially implanted patients received their second CI (three years
after initial implantation). No differences between groups were found for speech perception in quiet, speech
perception in noise, subjective hearing assessments or quality of life measures. A difference was found for
sound localization at 30 degrees with the simultaneous biCI group performing better. However, no differences
were seen for the 15 or 60 degrees conditions, suggesting minimal clinical importance of the difference seen at
30 degrees. The study concluded that bilateral implantation provides similar benefit whether the implantations
are performed simultaneously or sequentially. The randomized controlled design of this study adds strength to
these findings.
Data from the same study was analyzed to investigate the effects of unilateral and bilateral implantation by
comparing data collected one and two years after simultaneous implantation to one and two years after
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unilateral implantation (before the sequentially implanted group received their second implant) (van Zon et al.,
2016). Patients who used a contralateral hearing aid (bimodal stimulation) were tested bimodally; 12 at the 1-
year follow-up and 13 at the 2-year follow-up. No difference between unilateral and bilateral CI performance
was seen for the main outcome measure, speech perception in noise when both speech and noise were presented
from the front, or when speech was presented in quiet. However, biCI patients outperformed unilateral
implantees on speech perception in noise when the noise was spatially separated from the speech and when
speech was presented to the worse ear. Additionally, biCI patients outperformed unilateral implantees in all
sound localization tests, with a median performance of 97% correct when sounds were presented 60 degrees to
the right or left compared to 47% correct in the unilateral group. BiCI patients subjectively reported
significantly better speech understanding and spatial location of sounds than unilateral implantees, with no
difference in subjective quality of sound or quality of life measures. This study found a benefit of bilateral
implantation over unilateral implantation in the more difficult listening situations, a finding bolstered by the
strong study design. Data from the simultaneously implanted group was also assessed to determine whether the
patients experienced binaural integration (Kraaijenga et al., 2016). Evidence of binaural integration was found,
and this effect improved over the first 2-3 years after implantation.
A separate study tested speech perception of 24 sequentially bilaterally implanted children over two years
(Reeder et al., 2017). These patients were mostly pre- or peri-lingually deafened, with a long inter-implantation
delay that averaged 9 years. Although speech perception was significantly better monaurally with the first
implant than the second for word and sentence perception in quiet and in noise, listening with both CIs was
significantly better than with either ear monaurally in all conditions but sentences in quiet. Sound localization
was also better monaurally with the first implant than the second, but localizing bilaterally did not provide a
significant benefit over the first implant, suggesting minimal binaural integration. Shorter duration between the
first and second implantation and continued use of a hearing aid between implantation surgeries was associated
with better bilateral speech perception. Most of the children in this study were adolescents when they received
their second CI, and many had older technology in their first implanted ear. It is hoped that with current
guidelines allowing children to be implanted at younger ages with modern technology, improved outcomes will
be seen.
For patients with residual hearing in their non-implanted ear, a hearing aid (HA) contralateral to the CI can
improve speech perception in quiet and in noise, including lexical tones, and perception of melodic contour as
well as sound localization compared to listening through the CI alone (Crew et al., 2016; Choi et al., 2017;
Neuman et al., 2017; van Loon et al., 2017; Yang and Zeng, 2017). A study investigating differences between
patients who continued vs. discontinued use of a hearing aid (HA) contralateral to their CI found that 80/94
patients who initially used bimodal stimulation continued HA use (Neuman et al., 2017). Despite minimal
differences in audiograms, those continuing HA use experienced a significant improvement of word perception
in quiet when listening bimodally compared to the CI alone, but those discontinuing did not. Continuing HA
users also performed better on the AzBio sentences in noise test bimodally than with the CI or HA alone, but
these data were not available for the discontinued HA group. A subjective questionnaire confirmed that those
continuing HA use found bimodal stimulation helpful while those who discontinued did not, even after a
sufficient trial period of at least 3 months. Notably, audiograms and speech perception scores did not predict
which patients would continue or discontinue HA use; some patients with minimal residual hearing and/or very
low word perception scores found bimodal stimulation beneficial.
A study of speech perception and sound localization in 13 Korean children with bilateral CIs and 19 with
bimodal stimulation found that binaural hearing provided significant benefit to both groups (Choi et al., 2017).
Speech perception was tested in quiet and in 4 configurations of 8-talker babble: speech to the front with babble
from the front, right, left or left and right together. Both groups performed near ceiling in quiet. Bilateral and
bimodal listeners had similar responses except in the condition where noise was presented to the first or only
CI. In that condition, bimodal listeners performed significantly worse than bilateral listeners. Sound
localization did not differ between bilateral and bimodal listeners, but both groups were significantly worse
than age-matched normal hearing children. The groups did not differ on subjective assessments of speech
perception, spatial perception or quality of sound.
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5.3.3.3 Single-Sided Deafness (SSD) and Asymmetric Hearing Loss (AHL)
Nine reviewed studies investigated the use of CI in patients with single-sided deafness (SSD) or asymmetric
hearing loss (AHL), with all but one including SSD patients (Sladen et al., 2016; Arndt et al., 2017; Finke et al.,
2017b; Finke et al., 2017c; Holder et al., 2017; Skarzynski et al., 2017; Sladen et al., 2017; Thomas et al.,
2017), one including AHL patients only (van Loon et al., 2017), and two including both SSD and AHL patients
(Arndt et al., 2017; Skarzynski et al., 2017).
Significant improvements in speech perception in quiet were seen for SSD and AHL patients when comparing
scores using the CI only to pre-implant scores using the same ear (Sladen et al., 2016; Holder et al., 2017;
Sladen et al., 2017; van Loon et al., 2017) and when post-operative binaural scores were compared with the CI
on vs. the CI off (Skarzynski et al., 2017; van Loon et al., 2017). Speech perception in noise was also better
with the CI on compared to off (Sladen et al., 2016; Arndt et al., 2017; Thomas et al., 2017) and better
binaurally post-operatively compared to pre-operative scores (van Loon et al., 2017). The only study looking at
binaural speech perception in noise pre-operatively compared to post-operatively did not find a significant
difference in this condition despite an increase in average score from 59% to 72% correct (Sladen et al., 2017).
However, only eight patients were included in that analysis and non-parametric statistics should have been
used. Sound localization was also found to be better with a CI than without in SSD and AHL patients (Arndt et
al., 2017; Skarzynski et al., 2017; Thomas et al., 2017; van Loon et al., 2017). No differences between SSD
and AHL patients were seen on speech perception or sound localization outcomes (Arndt et al., 2017;
Skarzynski et al., 2017).
A study comparing CI-only speech perception outcomes between 52 adult SSD CI patients and 125 bilateral CI
(biCI) patients using their second CI only found that although biCI patients performed better with the CI only
than the SSD patients, both groups experienced significant gains on speech perception in quiet and in noise
between initial switch-on and 12 months later (Finke et al., 2017c). Pre-operative testing was not included in
that study, therefore post-operative benefit cannot be determined, but these data reveal that substantial
improvements in speech perception are seen over the first year with the CI. Another study of 20 adult and
pediatric SSD patients found improvements after 3 months with the CI compared to pre-operative scores, but no
further significant gains between 3 and 6 months post-operatively (Sladen et al., 2016).
Perception with the CI was compared to the use of Contralateral Routing of Signals hearing aids (CROS),
bilateral CROS or a bone-conducting device (BCD) in 20 SSD patients and 17 AHL patients that had trialed
these devices before implantation (Arndt et al., 2017). The best scores in all speech perception in spatial noise
conditions and sound localization were seen with the CI in both SSD and AHL groups, with some differences
reaching significance for some conditions in both groups. Speech perception with CROS was better than
listening monaurally without any device in one spatial condition only in both groups, but did not improve sound
localization. The BCD did not significantly improve perception over monaural listening with no device in any
condition.
Subjective CI benefit for speech perception, spatial hearing and quality of sound was reported by SSD and AHL
patients in all studies investigating this outcome, including studies with adults and children (Sladen et al., 2016;
Arndt et al., 2017; Finke et al., 2017c; Skarzynski et al., 2017; Thomas et al., 2017; van Loon et al., 2017). A
survey of SSD patients reported an overall sense of increased well-being since implantation that related to
sound localization, tinnitus, fear of hearing loss in the hearing ear and quality of life (Finke et al., 2017b). A
survey of AHL patients found that music appreciation of AHL patients increased with bimodal stimulation
compared to pre-operative assessments but did not achieve the level of appreciation noted before the onset of
hearing loss (van Loon et al., 2017). Tinnitus, a common complaint of SSD patients, was significantly reduced
with implantation in the three studies reporting tinnitus data (Holder et al., 2017; Skarzynski et al., 2017;
Sladen et al., 2017).
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5.3.3.4 Factors influencing CI outcome
CI outcomes are known to be highly variable, and many researchers are investigating factors that could impact
speech perception outcomes. The studies investigating these factors over the past year focused on adult CI
patients. Multiple studies found that the duration of deafness before implantation of postlingually deafened
adults significantly related to speech perception in quiet and in noise, with better outcomes associated with
shorter durations of deafness (Beyea et al., 2016; Dierickx et al., 2016; Hiel et al., 2016; van der Jagt et al.,
2016). Age at implantation of adult CI patients did not relate to speech perception (Dierickx et al., 2016;
O'Gara et al., 2016). Age at time of test also did not relate to speech perception outcomes (Hiel et al., 2016;
Sharpe et al., 2016), although one study found an effect using one test of sentence perception in quiet but not
another (Beyea et al., 2016). Electrode type was not found to affect speech perception outcomes (Dalbert et al.,
2016; Dierickx et al., 2016; O'Connell et al., 2016; van der Jagt et al., 2016). Spectral ripple discrimination was
found not to differ between adult and pediatric CI patients (Horn et al., 2017). Postlingually deafened patients
are known to perform better on speech perception tasks than prelingually deafened patients. One study
comparing these two groups found postlingually deaf patients to improve significantly over the first 3 years
with the CI, after which performance improved at a slower rate, while prelingually deaf patients took longer to
reach their performance plateau, improving up to 5 years after implantation (Cusumano et al., 2017). Another
study found younger adult CI patients to reach peak performance at 1 year (Hiel et al., 2016). Older patients
took longer to reach peak performance, increasing their scores for 2 years, at which point there was no longer a
statistical difference between performance of the two groups. Postoperative PTA did not generally relate to
speech outcomes (Beyea et al., 2016; Dierickx et al., 2016), however one study found a relationship in quiet but
not in noise, and another found better outcomes for patients with some hearing preservation after 18 months
with the implant but not at earlier test dates (Dalbert et al., 2016). A study of the impact of genetic factors on
speech perception in CI patients found patients with genetic variants in spiral ganglion cells performed
significantly worse than patients with genetic variants confined to the cochlea or other forms of cochlea-
specific damage (Shearer et al., 2017). This factor accounted for 18.3% of the variance in post-operative
speech perception outcomes.
Angular insertion depth of the electrode, number of electrode contacts inserted into the cochlea and scalar
dislocation were also found to affect speech perception (Hilly et al., 2016; O'Connell et al., 2016). A study of
120 postlingually deaf patients with a HiFocus 1j electrode found patients with insertions greater than 1 turn,
360°, performed significantly better than those whose arrays were inserted less than 360° (Hilly et al., 2016).
Comparable outcomes were seen with 360° and deeper insertions. They also found patients with only 12
contacts inserted performed significantly worse than those with all 16 contacts inserted. There were no
differences between outcomes of patients with 13, 14, 15 or 16 contacts inserted. This study demonstrates that
there is a minimum insertion depth necessary for maximum speech perception outcomes, but once that
threshold is reached, there is no statistical benefit of further insertion. Another study found that patients with all
electrodes inserted within the scala tympani (ST) performed better than those who had at least one electrode
inserted into the scala vestibuli (SV) (O'Connell et al., 2016). Electrode arrays designed to lie along the lateral
wall were least likely to have electrodes inserted into SV, with perimodiolar and midscalar designs more likely
to have SV incursions. Cochleostomy insertions were more likely to result in SV insertions than round window
and extended round window approaches. Angular insertion depth also significantly correlated with speech
perception scores in this study.
5.3.3.5 Music and Pitch
A study of music perception in prelingually and postlingually deafened CI patients and NH listeners found the
NH group performed better on pitch, melody, chord and instrument discrimination, but not rhythm
discrimination (Bruns et al., 2016). The only significant difference between CI groups was seen for instrument
discrimination in which postlingually deafened CI users outperformed prelingually deafened CI users. Both the
NH and postlingually deafened CI users produced the N400, an electrophysiologic marker of semantic
meaning, in response to congruent vs. incongruent words associated with musical excerpts. The prelingually
deafened CI group did not produce an N400 during this task. Postlingually deafened CI users rated music
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appreciation lower than either other group at the time of the test, however both CI groups reported significant
improvements in their music appreciation when compared to pre- vs. post-implantation.
Another study measured neurophysiological markers of auditory tonal discrimination (mismatch negativity, or
MMN) in four groups of listeners: prelingually deafened CI users, postlingually deafened CI users, SSD CI
users and age and gender matched normal hearing controls (NH) (Hahne et al., 2016). In the first experiment,
subtle changes in pitch, timbre, intensity and rhythm were assessed. NH and CI groups differed significantly
for pitch, intensity and rhythm deviants, but not for timbre, but no differences across CI groups were found. In
the second experiment, more pronounced changes were tested. NH and CI groups differed significantly for
pitch, timbre and intensity, but not rhythm. CI groups did not differ from each other in timbre, intensity or
rhythm responses, but differed in response to the pitch deviants, with the postlingually deafened patients
showing the largest MMN and prelingually deafened patients showing the smallest. The study showed that CI
users can neurophysiologically distinguish relatively small changes in tonal stimuli.
A study of instrument identification and discrimination of natural timbre stimuli and those with modified pitch
and envelope cues found NH listeners were better than CI patients at identifying the natural and altered timbres
(Prentiss et al., 2016). Discrimination by the CI group did not differ when envelope cues were removed,
suggesting that the fine structure of the stimuli was perceived. CI patients and NH listening to vocoded stimuli
(CI simulation) preferred musical excerpts with restricted harmonic series over those containing full harmonics
(Nemer et al., 2016)
Pediatric perception of spectrally complex stimuli was assessed in CI and NH children (Sjoberg et al., 2017).
Pitch discrimination thresholds and timbre recognition were significantly better in the NH group than in the CI
group. However, NH children listening to vocoded stimuli performed less accurately than CI children on
timbre recognition and sentence perception in both quiet and noise. Talker discrimination did not significantly
differ between CI children and NH children listening to vocoded stimuli, but CI children had more variable
performance. Differences were attributed to the acute nature of vocoded simulation testing compared to the
long duration of acclimatization to electric hearing in the CI group. In both groups, music experience predicted
better scores on the pitch and talker discrimination tasks but not timbre identification.
A study of pitch matching across acoustic and electric hearing in asymmetrically deaf patients found that some
adaptation in pitch percept may occur after CI, but this may not be complete in some cases (Tan et al., 2017). A
study of pitch matching across ears in bilaterally implanted CI patients found pitch mismatches across ears of
bilateral CI patients is likely prevalent, even after extended bilateral use, potentially limiting their ability to
access binaural benefits from the bilateral implants (Aronoff et al., 2016).
5.3.3.6 Psychophysical studies
The characterization of speech perception through a CI compared to normal hearing listeners (NH) continues to
be of investigative importance. One study found that the importance of specific frequency bands to speech
perception differed between NH and CI users, with more variability within CI users and even between ears of
single CI users (Bosen and Chatterjee, 2016). Additionally, CI users relied more heavily on lower frequencies
than NH listeners. Another study assessed the amount of auditory enhancement experienced by experienced CI
listeners in a variety of simultaneous and forward masking conditions and found some aspects of auditory
enhancement were present in the CI listener's data, but others were not (Kreft and Oxenham, 2017). CI patients
were found to perform similarly on a speech perception task to normal hearing listeners presented with vocoded
speech, a method of simulating sounds heard through a CI (Winn, 2016).
A separate study investigated whether CI patients "rate normalize" to different rates of speech and if their
phonemic boundaries are similar to those of NH listeners, whose phonemic boundaries are mediated by speech
rate (Jaekel et al., 2017). CI listeners had larger effects of rate normalization than NH listeners but had less
reliable phonemic boundaries. When NH listeners were presented with vocoded speech, or CI simulated
speech, their category boundaries also became less reliable. Older age-matched NH listeners had more of an
effect of vocoded signal degradation on category boundaries than younger NH listeners.
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Nineteen adult CI patients and ten normal hearing adults (NH) performed a battery of perceptual tests of
spectral and temporal processing, syllable discrimination and word perception (Winn et al., 2016). NH listeners
outperformed CI users generally. For CI users, spectral processing significantly related to categorization of
speech formant transitions, and these tasks both related to word recognition. Temporal modulation detection
did not correlate with discrimination of syllables differing by voice onset time or with word recognition. Word
recognition was more related to tasks using speech stimulus aspects than the psychophysical discrimination
tasks.
The benefit of head orientation when CI patients listen to speech in noise was investigated in CI patients and
NH listeners (Grange and Culling, 2016). The benefit of head orientation of unilateral CI users matched that of
young normal hearing listeners, 5 dB, when the noise masker was presented from behind the listener. A smaller
but still significant benefit of 2.5 dB was seen in unilateral CI listeners when the masker was presented to the
CI side. Bilateral CI patients received less benefit from head orientation, likely because they benefit from
summation when the signal is equal at both ears.
5.3.3.7 Stimulation and processing strategies
A number of studies investigated the effects of various CI stimulation strategies on speech perception (Cucis et
al., 2016a; Cucis et al., 2016b; Hughes et al., 2016; Luo and Wu, 2016; Langner et al., 2017; Nogueira et al.,
2017; Padilla et al., 2017; Vellinga et al., 2017). One study introduced a new transient noise reduction
algorithm (Dyballa et al., 2016). Beamformers were found to improve perception of speech in spatial noise for
bimodal CI users, with maximal benefit achieved when symmetric monaural beamformers were used in
conjunction with both the CI and the HA (Devocht et al., 2016). A study assessing the use of the UltraZoom
beamformer in 34 patients upgraded to a Naída CI Q70 sound processor found a significant benefit for speech
perception in noise when UltraZoom was turned on (Mosnier et al., 2017). A pair of studies investigated
whether microphone cleaning would improve CI speech perception (Cucis et al., 2016a; Cucis et al., 2016b).
Neither found much effect of cleaning, but it was unclear if the microphones were dirty enough to require
cleaning.
5.3.3.8 Other topics
The P1 auditory evoked potential was found to be a biomarker of auditory development in pediatric CI users
(Silva et al., 2017). Word recognition was significantly related to emotional perception in a group of
congenitally deaf pediatric CI users (Mancini et al., 2016). Speech perception of monosyllables, spondees and
sentences in quiet and in noise through a CI was found to be similar between children with and without isolated
auditory neuropathy (Attias et al., 2017). Electrocochleography (ECoG) and audiometric thresholds strongly
correlated in a group of 20 CI patients, suggesting a method for determining thresholds in patients who cannot
perform the audiometric tests (Koka et al., 2017). Another study by the same group found it was possible to
evaluate interactions between electric and acoustic stimulation in EAS patients with ECoG, although these
measures did not relate to behavioral measures of the interaction (Koka and Litvak, 2017). Attempts to
improve the fitting of CIs through the use of auditory evoked potentials, deactivating electrodes thought to
interfere with neighboring electrodes as determined through CT scan analysis, and the use of fitting algorithms
contained in the software application FOX ('Fitting to Outcome eXpert') were reported (Finke et al., 2017a;
McRackan et al., 2017; Meeuws et al., 2017). The feasibility of online speech perception testing of CI patients
in conjunction with a long-term follow-up clinical questionnaire for determining whether or not a CI patient
needs to come in to the clinic was assessed using the digit triplet test of speech perception in noise (Cullington
and Agyemang-Prempeh, 2017; Cullington and Aidi, 2017). The Hearing Implant Sound Quality Index
(HISQUI19) was translated for Brazilians taking into account cross-cultural matters and tested in 33 adult CI
patients (Caporali et al., 2016).
A parental survey of pediatric CI use and efficacy found that parents believe their children hear better in quiet
environments than in noisy environments, and better in smaller rather than larger groups (Nelson et al., 2016).
Approximately 3/4 of respondents reported that their children were doing as well as or better than other
children in their grade level academically. 96% reported that the CI had met their expectations, with 99%
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saying they would make the decision to implant again if they had to do it over. The results of this study report
generally favorable outcomes of pediatric CI users.
Questionnaires filled out by 174 CI patients characterized long-term outcomes including education and
employment levels of prelingually deaf adolescents and adults implanted during childhood (Illg et al., 2017).
87% wore their CI 11 hours or more each day, with 2% non-users. Higher Categories of Auditory Perception
(CAP) scores were found for patients who were postlingually deafened or implanted before the age of 3.
Patients who self-assessed that they were able to understand (vs. partially understand) speech without
lipreading, read and understand (vs. partly understand) books and newspapers and express themselves through
writing (vs. partly) had higher CAP scores. CI users achieved a lower level of education and worked in less-
skilled jobs than their normal hearing peers, with a lower rate of employment. The authors predict that because
children are now implanted at younger ages with better technology, their educational and occupational
prospects will be better than the patients included in this study who were implanted as children years ago.
A study assessing the efficacy of adding CROS hearing aids (contralateral routing of signal) to unilateral CI in
5 AB patients found no effect in quiet (Taal et al., 2016). In noise, speech perception was worse with CROS
than without it when speech was presented to the CI side. The opposite pattern was seen when speech was
presented to the unimplanted ear. This study only included five patients and did not describe the statistics they
used to determine significance. A larger study is necessary to determine whether the CROS system is
beneficial to unilateral CI users.
Auditory, visual and audio-visual perception of speech was compared between 6 CI patients, 6 patients with
auditory brainstem implants (ABI), 2 patients with auditory midbrain implants (AMI) and 6 normal-hearing
controls (NH). All groups performed equally poorly in the visual only condition, averaging 16% correct or
less. The NH group performed better than the CI and ABI groups on the auditory and audio-visual conditions,
but the CI group significantly outperformed the ABI group on the auditory and audio-visual conditions. The
two AMI patients performed similarly to the ABI group. The ABI group received significantly more benefit
from adding the visual stimulus to the auditory alone stimulus than either the CI or NH groups.
Safety Studies
The safety of cochlear implantation was upheld in the papers published over the past twelve months. No new
safety concerns were uncovered in this review; all issues have been previously reported. No complication was
found to be more prevalent than previously reported.
5.3.4.1 Characterization of complications seen in large cohorts
No adverse events were seen in 117 minimal access CI surgeries on adults and children performed at a single
center in Saudi Arabia (Alrashidi et al., 2017).
Major and minor complications in 1,014 patients (1,065 implants) implanted between 2006 and 2015 using
minimally invasive techniques at a single Chinese institution were reviewed (Jiang et al., 2017). Seven major
complications were encountered in this cohort (0.6%) a rate significantly lower than other reports in the
literature. Four were electrode misplacement or CSF leak in patients with anatomical abnormalities, and the
other three were magnet displacement or device failures due to head trauma. Twenty-one minor complications
occurred (1.97%). The bulk of these were chorda tympani dysfunction (n=10) and superficial wound infection
(n=5), with temporary facial nerve weakness, hematoma and facial nerve stimulation occurring less frequently.
A systematic review of the literature revealed changes in complication rates over time, with infection occurring
most often in implantations performed before 2000 and device failures occurring more often after 2000, with
the rate of device failures declining after 2010.
This study analyzes complication rates of 579 pediatric cochlear implantations performed at a private practice
in the US and finds an overall complication rate of 23% (Sivam et al., 2017). The majority of complications
were mild and brief, with 82% of all complications being nausea/vomiting or imbalance/dizziness which were
resolved through outpatient treatment. One percent of all CI patients required unplanned medical treatment.
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Similar overall complication rates were seen between patients receiving lateral wall vs. perimodiolar electrode
arrays. However, more CSF leaks were seen with the lateral wall electrodes, likely due to the anatomical
abnormalities such as Mondini associated with choosing a lateral wall electrode. Bilateral implantations had a
higher complication rate than unilateral implantations, likely due to the longer time spent in surgery. Higher
rates of nausea/vomiting have been associated longer surgical times across various surgical procedures, so this
complication is not specific to CI.
The number and type of flap-related complications in a large cohort of CI patients implanted by a single
surgeon in China are reported (Qin et al., 2016). The text is unclear as to exactly how many patients were
reviewed, but the rate of flap-related complications is reported as 3.7% which is within the range reported in the
literature. Forty-two cases of flap-related complications are reported, with 6 major and 37 minor cases.
Subperiosteal hematomas were most prevalent with 20 reported cases, all of which were successfully treated
with antibiotics and pressure dressings. Local swelling was seen in 15 cases. Ten of these were successfully
treated with drainage, pressure dressing and antibiotics. Five were unresponsive to this treatment and
eventually showed implant extrusion, requiring explantation and reimplantation in the contralateral ear. One
case of wound infection, 4 wound abscesses and 2 cases of flap necrosis with implant extrusion were
successfully treated excepting one of the flap necrosis cases which continues to be monitored.
The implantations of 103 children and 94 adults (266 ears) performed by a single surgeon at a tertiary center in
the US were reviewed to assess the clinical utility of intraoperative testing (Page et al., 2017). All children and
24 adult implantations were performed with intraoperative testing, and 88 implantations were performed in
adults without intraoperative testing. Intraoperative testing led to use of the back-up device in 2 cases (0.8%).
One of these cases involved implantation of a 1j array in a 1-year-old with anatomical abnormalities, with
impedances suggesting ipsilateral facial monitor stimulation. X-ray verified correct CI placement. AB was
contacted and recommended use of the back-up device. After re-implantation the same finding occurred, but
the array was left in place. After more than a year with the CI, a good functional outcome has been achieved
with no facial nerve activation. The other case involved open electrodes on an adult 1j recipient. When
contacted, AB recommended use of the back-up device, which was used and the issue resolved. The patient is
reported to be doing well and has experienced no complications. Three cases (1.1%) required intraoperative X-
ray to confirm electrode placement, all of which showed intracochlear placement. Twelve complications are
reported in this series (4.5%), with all complications and their rate of occurrence within what is to be expected
with CI surgery. The authors argue that there is generally not a need for intraoperative testing in standard cases
with no anatomical abnormalities.
5.3.4.2 Analyses of specific complications
Electrode migration was found to occur in 10/358 (2.8%) ears implanted with free fitting lateral wall electrodes
using hearing preservation surgical techniques, a rate consistent with previous literature (Rader et al., 2016). In
contrast, no electrode migration was found in any of the 468 ears implanted with precurved perimodiolar
electrode arrays (0%). None of the ten patients experiencing electrode migration wore AB devices. Patients
who were found to have electrode migration experienced a drop in speech perception averaging 13 percentage
points which returned to pre-migration levels after re-implantation. A flow chart to aid clinicians in detecting
electrode migration is supplied in the article.
The incidence of electrode array tip fold-over was found to be a rare complication seen in 6/303 implanted ears
(1.98%) (Zuniga et al., 2016). This rate is consistent with previous literature. This complication was not
immediately clinically obvious and was detected with post-operative CT scans. Three of the patients had their
electrodes selectively deactivated, a procedure which improved speech perception in two cases.
A study reported that 20/1448 cases (1.3%) of pediatric implantations at a French CI center developed pain at
the implantation site after the post-implantation period (.25-14 years later, mean 5.8 years) (Celerier et al.,
2017). Two patients experienced two cases each, therefore 18 patients were included. Patients were treated
with painkillers and anti-inflammatories, along with antibiotics if swelling was involved, and this resolved 8
cases. The magnet was replaced in 3 cases, resolving 2. Ten explantations and reimplantations were
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performed, resolving the remaining cases. No device failures or abnormalities were found when explanted
devices were analyzed by the manufacturers. Three out of ten explanted devices or magnets tested positive for
microbial culture and five out of seven biofilms tested were positive. All cases of pain at implant site were
resolved with varying levels of treatment. Two cases of the rare complication of pain when the cochlear
implant is turned on with no other symptoms were reported (Anand et al., 2016). Both cases were successfully
treated without the need for explantation by tympanic neurectomy accomplished with a CO2 laser.
The rate of infections, with a focus on infections of the CI device, was investigated in a large cohort of pediatric
CI recipients (568 implants, 421 patients) implanted at a single center in the US between 1999 and 2013 (Vila
et al., 2017). 18% of ears experienced otitis media at least once after implantation. 4.6% experienced otitis
externa. 22 ears (3.8%) experienced internal device infections, with 16 of these originating from otitis media
infections, and the other 6 with no evidence of middle ear infection. Of the 16 cases in which otitis media
spread to the CI, 10 were successfully treated with antibiotic therapy and the CI remained in place, and 6 were
explanted. A further 4 cases of device infection not related to middle ear infection required explantation.
Staphylococcus aureus was associated with a high rate of explantation (5/7, 71%) while 4/14 (29%) of implants
infected with other organisms more commonly associated with otitis media required explantation. 81 total
device explantations occured over the 14-year period for any reason (14%), with device failure the most
common reason (n=71), followed by implant infection from otitis (n=6), implant infection not associated with
otitis (n=4), device extrusion (n=1), and electrode migration (n=1). Otitis media was found to be relatively
common in pediatric CI recipients and did not usually extend to infections of the CI site or device. However,
this did happen on occasion and was sometimes successfully treated with antibiotics, but other cases required
explantation of the device. Cases of device infection have been reported in the literature previously and are not
a new concern.
A questionnaire regarding experience of dizziness, tinnitus and taste disturbances was developed and sent to CI
patients who had been implanted as adults (Mikkelsen et al., 2017). Of the 77 patients who returned the
questionnaire, 20% reported dizziness, 52% tinnitus and 3% taste disturbances pre-operatively. Dizziness
developed post-operatively in 46%, with most of brief duration, but 15% continued to experience dizziness
more than 6 months after implantation. Most patients with pre-operative tinnitus reported attenuation or
termination after implantation, but it worsened in 25%. Tinnitus developed post-operatively in 12%, and taste
disturbances developed in 17%. Dizziness and tinnitus were described as common both before and after
implantation in CI patients, with a significant proportion experiencing taste disturbances. The results reported
in this study support previous studies investigating these complications. Another study assessed effect of CI on
vestibular function in 16 pediatric CI users (Nassif et al., 2016). The study included both unilateral and
bilateral CI patients, and did not find a difference between vestibular function of implanted vs. normal hearing
children. Vestibular function was not found to be compromised by cochlear implantation.
The effect of CI on tinnitus was characterized in 52 postlingually deafened unilaterally implanted adults who
had persistent tinnitus after implantation of 6 months or more (Wang et al., 2017). 34 patients had bilateral
tinnitus, 8 had tinnitus in the CI ear only, and 10 in the contralateral ear only. Ipsilateral and contralateral
tinnitus loudness was significantly lower when the CI was on vs. off. Complete or partial suppression of
ipsilateral tinnitus was accomplished by turning on the CI in 86%, unchanged in 12%, and aggravated in one
patient. Interestingly, tinnitus contralateral to the CI was completely or partially suppressed by the CI in 80%.
The prevalence of headache during the year after implantation was assessed in 78 CI patients and compared to
79 patients who had received middle ear surgery and 77 patients who had not had any ENT surgery (Ear, Nose,
Throat), recruited from General Surgery, Internal Medicine and Urology departments (Kisser et al., 2016).
Twenty-four CI patients (30.8%), 36 middle-ear surgery patients (45.6%) and 49 non-ENT patients (63.6%)
reported having a headache within the past twelve months. The non-ENT group reported significantly more
headaches and more frequent headaches than either the CI or middle-ear surgery groups which did not differ.
There was no significant difference across groups in the onset or intensity of the headache. Cochlear
implantation was not associated with an increased prevalence of headache.
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5.3.4.3 Case studies/ Case series
The cases of five patients with delayed haematoma occurring 2-12 years after CI (two patients with two
incidences, 7 total events) were reviewed (Low and Xu, 2017). All cases were treated with needle aspiration
and/or incision and drainage. Two of the three cases with bacterial culture were negative, however the positive
case was not held up with subsequent testing and was suspected to be due to needle contamination during the
aspiration procedure, not a cause of the event. All CIs were left in place. This rare complication has been
reported in the literature previously and is not a new concern.
A 10-year-old CI patient who had been implanted unilaterally at age 2 developed a local soft tissue infection at
implant site that recurred multiple times over 6 months (Sharma et al., 2017). The implant appeared to be in
place and functional, and there was no indication of systemic involvement, therefore the infection was
surgically treated without removal of the implant. Long-term antibiotics were administered. The treatment was
successful and the implant remains functional with no recurrence of the infection seven months after the
intervention.
One report details cochlear histopathology of an elderly patient's temporal bone implanted with a HiFocus CII
with positioner (Kamakura and Nadol, 2016a). This device, designed to position the electrode array close to the
modiolus was recalled in 2002. Extensive cochlear damage was seen, including scalar dislocation. New bone
formation and fibrous sheath were noted in addition to fluid around the device. Results from this patient were
compared to those of a patient bilaterally implanted with the same device described in a previous paper
(Seyyedi et al., 2013). In that patient, although there was cochlear trauma, less structural damage was seen and
better speech perception was achieved (66% vs. <10% correct). This study investigated cochlear trauma caused
by a legacy device and does not raise any new concerns.
Two cases of patients whose CI electrode was misplaced into the Fallopian canal while undergoing CI
replacement for soft failure in long-standing devices were reported (Alyono et al., 2017). In both cases, there
was no difficulty of insertion or undue force associated with the surgery. One case was for a revision of a
Cochlear Nucleus 22 array, replaced with a Cochlear Slim Straight array, the other for revision of a HiFocus 1j
array, also replaced with a Cochlear Slim Straight array. Both cases were managed by deactivation of the
misplaced contacts, and both received benefit from their CI. The authors cite previously reported
histopathology analyses for possible reasons for this type of electrode displacement.
5.3.4.4 Cochlear Trauma
Histopathologic measures of cochlear trauma measured in temporal bones of deceased CI users was found to be
related to word perception scores obtained before death (Kamakura and Nadol, 2016b). CNC word perception
scores of these 17 patients ranged from 10% to 74% correct, and a range of cochlear trauma was seen in the
temporal bones. Better CNC word scores were associated with higher spiral ganglion cell counts. Poorer CNC
word scores related to higher amounts of new bone growth within the cochlea and longer lengths of the
electrode array placed outside the intended target of the scala tympani. Both of these histologic measures were
associated with higher amounts of cochlear damage. Word scores did not relate to the amount of fibrous tissue
within the cochlea. This study supports atraumatic insertion of CI electrodes for better speech perception
outcomes.
The relationship between intracochlear force measurements in the x, y and z planes and intracochlear trauma
was explored in 27 insertions of the HiFocus 1j electrode array into ten temporal bones (Avci et al., 2017). The
array was inserted using an automatic insertion tool with a constant speed of 0.5 mm per second. Force
measurements over time of insertion were related to videos recorded through a microscope, and subsequent CT
scanning. If no intracochlear trauma was observed, the array was inserted up to three times in each temporal
bone. Seven of the ten bones were analyzed after these insertions for intracochlear trauma, three could not be
analyzed. Six of the seven analyzed temporal bones showed intracochlear trauma, frequently at the basal end:
three with damage to the basilar membrane and six with ruptured spiral ligament. The study focuses on trauma
and does not report the number of trauma-free insertions, but this can be inferred to be at least 18/27 based on
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methodology. Angle of insertion and cochlear geometry significantly impacted insertion forces. Intracochlear
force profiles were correlated with intracochlear trauma. However, higher forces were not necessarily
indicative of trauma; electrode buckling was associated with decreases in force.
Five different electrode array types from Cochlear and Advanced Bionics, including the HiFocus MidScala
(HFMS) and HiFocus 1j electrode arrays, were each inserted into 12 human temporal bones. Intracochlear
pressures within the scala tympani (ST) and scala vestibuli (SV) were measured during each insertion. A
pressure difference between these locations was also computed for each insertion. Pressure transients were
observed during all insertions. Slight variations in amplitude of peak pressure transients were seen across
electrode models, with the 1j producing the largest pressures. This difference did not relate to general style
(e.g. straight vs. perimodiolar), electrode length or apical diameter. It did relate to basal diameter and electrode
volume for ST pressure (but not SV or difference between ST and SV). This relationship suggests that pressure
transients could be reduced with larger cochleostomy.
5.3.4.5 Hearing Preservation
Factors relating to post-implantation hearing preservation continue to be investigated. In one study of 64 adult
and pediatric patients, thresholds across all frequencies significantly increased after implantation (Eshraghi et
al., 2017). However, complete hearing preservation was found in 17% of the patients, partial preservation in
24%, minimal preservation in 23% and no preservation in 36%. The degree of hearing preservation did not
relate to age at implantation, gender, side of implant, device manufacturer, full or partial electrode insertion, or
whether the patient became deaf pre-lingually or post-lingually. Soft sugery, defined as slow insertion of the
electrode array, no aspiration of perilymph, and packing of the cochlear opening with fascia, was associated
with increased hearing preservation. Another study of hearing preservation in 35 children (43 ears implanted
with a full-length electrode found 65% retained some functional hearing after implantation (thresholds <=85
dB), with 39.5% achieving full preservation, 44.2% partial preservation, and 16.3% no preservation (Carlson et
al., 2017). Preservation did not relate to style of electrode (lateral wall vs. perimodiolar), surgical approach
(round window vs. cochleostomy), or age at implantation. Another study found that surgically extending the
round window opening and treating the electrode with a hydrophilizing substance, changes intended to decrease
intracochlear pressure during surgery, significantly increased the amount hearing preservation achieved in
patients implanted with the HiFocus Midscala array (Todt et al., 2016). A larger study of hearing preservation
in 196 postlingually deafened adult CI patients implanted with conventional-length arrays (225 implants)
defined hearing preservation conservatively as thresholds ≤80 dB at 250 Hz (Wanna et al., 2017). After 12
months or more, some patients were lost to follow-up but 33/188 patients (18%) met this criterion. Patients
with better pre-operative thresholds at 250 Hz were more likely to retain functional hearing. Patients with
lateral wall or midscalar electrode designs were significantly more likely to retain functional residual hearing
than those with a perimodiolar design in the short-term. At the 12-month follow-up the advantage of lateral
wall arrays persisted, but the difference was no longer significant for mid-scalar arrays. Surgical approach was
not independently a significant factor at either timepoint, but round window approach was related to a smaller
shift in low-frequency PTA. The use of post-operative steroids was not significant in the short-term but
became significant in the long-term. Age at implantation did not affect hearing preservation. 47% of patients
implanted with lateral wall electrodes via the round window retained functional low-frequency hearing
thresholds at activation, and 30% of them retained it in the long term.
Two studies comparing Advanced Bionics’ HiFocus MidScala (HFMS) array to the HiFocus 1j lateral wall
array both found better preservation of residual hearing with the HFMS, an array designed to improve hearing
preservation (Svrakic et al., 2016; Benghalem et al., 2017). In one of these studies, 6/7 patients receiving the
HFMS electrode array and 1/11 patients receiving the HiFocus 1j electrode array maintained hearing thresholds
at 500 Hz within 10 dB of pre-implantation levels, a strict criterion. Four patients implanted with each
electrode had measurable hearing at 1 kHz pre- and post-implantation. The 4 HFMS patients maintained their 1
kHz hearing within 5 dB after implantation, but all 4 HiFocus 1j patients had threshold shifts of 10 dB or more
(Benghalem et al., 2016). In the other study comparing the HFMS and 1j arrays, hearing preservation was
analyzed in 28 patients who had thresholds better than 100 dB pre-operatively (15 HFMS, 13 1j) (Svrakic et al.,
2016). Significantly more hearing was preserved with the HFMS electrode array. Post-operative thresholds
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were maintained at or below 100 dB in 7/12 (58%), 2/ 9 (22%), 1/6 (17%), and 0/6 (0%) patients implanted
with the 1j electrode at frequencies of 250, 500, 1000, and 2000 Hz, respectively. In comparison, post-operative
thresholds were maintained at or below 100 dB in 9/14 (64%), 6/11 (55%), 2/6 (33%), and 3/4 (75%) patients
implanted patients with the HFMS electrode across the same frequencies. It should be noted that a separate
study comparing the 1j and HFMS arrays, reviewed above, found no difference in speech perception in patients
implanted with these two arrays, and implant design and angular insertion depth had no effect on speech
perception scores (van der Jagt et al., 2016).
Surgical issues surveyed in one of these studies found minimal differences between the HFMS and 1j electrode
arrays (Svrakic et al., 2016). HFMS electrodes took slightly but significantly longer to surgically implant than
the 1j electrodes. One patient in each group had an incomplete insertion due to dysplastic cochleae. One
HFMS patient's array showed tip fold-over and was corrected before the patient woke up from surgery. Late-
onset wound infections occurred in 2 HFMS and 1 1j patients, a known concern. Two 1j electrodes failed after
3.3 and 5.6 years, with no HFMS electrodes failing, although the follow-up time for HFMS patients was
shorter. Very few electrodes demonstrated intraoperative high impedance values in either group (1.7% HFMS,
0.9% 1j), with most resolving by CI switch-on. A low incidence of abnormal intraoperative neural responses
was seen, with 10 occurring in the HFMS group (16.4%) versus 7 in the 1j group (11.5%).
5.3.4.6 Other Safety Issues
The use of a retractor tool during CI surgery was found not to affect adverse events or surgical duration
(Alrashidi et al., 2017). The clinical utility of MRI scans performed on patients with unilateral CI who were
scanned with the CI magnet in place since 2007 was investigated (Sharon et al., 2016). Different scanning
sequences provided varying clinical utility, with more or less artifact. Specific scanning sequences are
discussed. Safety issues were not addressed in this study.
Twelve temporal bones of patients who had been implanted with perimodiolar AB electrode arrays or Cochlear
straight lateral wall arrays were analyzed to determine whether the pattern of thickness of fibrous sheath found
on the electrodes related to duration of deafness, cochlear damage or auditory outcomes (Ishai et al., 2017).
One of the electrode arrays characterized as perimodiolar, the 1j, does have a slight curve but is generally
considered a straight array. Two out of five lateral wall arrays (Nucleus 22) and three out of six perimodiolar
arrays (2 HiFocus I, 1 HiFocus 1j) showed scalar displacement into scala vestibuli, not a significant difference.
Five out of seven perimodiolar arrays and two out of five lateral wall arrays caused substantial intracochlear
damage and this was a significant difference. The two undamaged cochleas with perimodiolar arrays were
implanted with contemporary AB models, 1j and Helix, implanted for only 2-3 years, suggesting a relatively
recent implantation. The perimodiolar arrays that caused damage were implanted 8-12 years before death,
excepting one that was implanted for 2 years in a bilateral CI patient. The other side was not damaged.
Intracochlear trauma has been a subject of investigation in recent years and electrodes and surgical techniques
have been developed to minimize this trauma.
However, while these factors decrease the incidence of cochlear trauma compared to implantations performed
historically, it still occurs. Straight electrodes such as the Cochlear arrays seen in this study have been shown
to cause less cochlear trauma than perimodiolar designs. The thickness of the fibrous sheath surrounding the
electrodes was thickest on the medial side of the perimodiolar implants, close to the modiolus. The medial
thickness was significantly thicker than the superior (towards osseous lamina) and inferior thickness. Fibrous
sheaths surrounding the lateral wall electrodes were more evenly thick around the electrode. The increased
thickness on the medial side of the perimodiolar electrodes may be related to their design. The sheath around
the 1j electrodes, which has only a slight curve and is considered more of a straight electrode, had thicknesses
between those seen with the more curved and straight designs. Additionally, the AB arrays are partially
banded, focusing the current towards the modiolus, whereas the Cochlear arrays are fully banded, spreading the
current around the circumference of the array. The thickness of sheaths did not appear to relate to proximity to
electrode contacts, and was not related to word perception scores, duration of implantation, or whether the
electrode was inserted via the round window or a cochleostomy. Fibrous sheath thickness does not currently
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have an obvious clinical effect on the safety or efficacy of CI. The mechanisms of fibrous sheath formation and
its effect on CI outcomes remain unclear and require further study.
General Lit Review – 2015-2016
This general literature review includes all studies published over the past year (July 2015 – June 2016) that
include safety or efficacy data from at least one Advanced Bionics device. Many studies include devices of
multiple manufacturers in their dataset, therefore this review is a snapshot of the cochlear implant field as a
whole, with a focus on Advanced Bionics products. No new problems were discovered in this search. The
literature continues to demonstrate that cochlear implantation is both safe and effective. Efficacy papers, those
assessing auditory outcomes, are described first, followed by a discussion of the papers covering safety issues,
with a summary statement at the end.
The 2015-16 annual general review was performed according to MEDDEV 2.7/1 Rev. 3 guidelines because it
was completed before the updated Rev. 4 guidelines were published. Each review was re-assessed to determine
if using the newer guidelines would change the review’s outcome. This assessment determined that the
conclusions of the reviews would not change if the new guidelines were used. This decision was reached for a
number of reasons:
 Each study included in the reviews was thoroughly assessed in terms of scientific rigor, relevance of
outcomes, generalizability to the CI patient population as a whole, appropriate statistical analysis,
report quality and relevance to the scope of the review. The changes required by the new MEDDEV
guidelines require more rigorous documentation of these assessments, but conclusions themselves
would not change because the required appraisals were already performed and incorporated into the
report. Changing the format would not change its conclusions.
 Any paper reporting a safety issue involving AB devices was carefully reviewed by the clinical
research team and already addressed accordingly in the text.
 No new safety issues related to cochlear implantation were discovered in any of the reviewed studies.
The numerous studies describing efficacy of cochlear implantation overwhelmingly report significant gains in
auditory ability attributed to the implant.
Efficacy
5.3.6.1 Speech perception
As in previous years, many of the studies involving cochlear implant outcomes concern speech perception and
the various factors affecting how well a CI patient can understand speech. Evidence that duration of deafness
before implantation and age at implantation affect speech perception with a CI continues to be contradictory,
with some papers finding significant relationships (Hilly et al., 2016; van der Beek et al., 2016) and others
finding no relationship (Canale et al., 2015; Jolink et al., 2016; Kraaijenga et al., 2015; Moberly et al., 2016;
Phan et al., 2016). None of these studies compared outcomes from babies implanted at a young age to those
implanted after a longer delay. Two studies finding an effect of age showed that adults implanted in middle age
(mean 44 years) had better speech in quiet outcomes than those implanted at an older age (means 67-68 years)
(Carvalho et al., 2016; van der Beek et al., 2016), although the differences in speech perception between groups
were relatively small, a difference of 4-6 percentage points. Similarly, elderly implanted patients performed
worse on speech in noise tasks than younger patients (Hilly et al., 2016). This last result is not unexpected, as
older normal hearing adults have more difficulty understanding speech in noise than younger listeners.
However, the elderly patients received significant clinical benefit from their CI that did not deteriorate over the
five-year follow-up period. Speech perception in quiet was not found to differ between older and younger CI
patients (Jolink et al., 2016). In a longitudinal study of CI children, bimodal experience related to improved
phonological scores, and mean length of utterance when younger predicted both phonological and
morphosyntactic skills at second grade (Nittrouer et al., 2016).
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Multiple factors relating to word perception with a CI were investigated in a large group of 428 patients, with
58 prelingually deaf and 370 postlingually deaf patients (Kraaijenga et al., 2015). Postlingually deaf patients
had significantly better speech perception 1 year after implantation than the prelingually deaf group. Within the
postlingually deaf group, age at onset of deafness and aided pre-implant speech perception positively
correlated, and otosclerosis and meningitis were negatively correlated with speech perception post-implant. Age
at implantation, duration of deafness, pre-implant PTA, gender and side of implant did not relate to speech
perception. Within the prelingually deaf group, only aided pre-implant speech perception and PTA significantly
predicted outcomes, with pre-implant speech perception explaining 31% of the variance.
Other studies also found pre-implantation measures to relate to speech perception with a CI, including the size
of central visual fields (Kim et al., 2016) and the ability of patients to speak clearly (van Dijkhuizen et al.,
2016). Therefore, some pre-implantation factors may help clinicians predict which CI candidates would receive
the most benefit from a CI. Test administration methods, lexical properties of word lists, and reverberation
properties of testing rooms were also found to affect speech perception scores (Bierer et al., 2016; Iglehart,
2016; Uhler et al., 2016).
Another paper investigating how an array of factors may influence speech perception in CI users was published
this year (Moberly et al., 2016). This study used cop-cob and sa-sha contrasts as well as nonspeech tokens
highlighting temporal and spectral aspects of these pairs as stimuli. Word recognition was not significantly
related to measures of word reading, expressive or receptive vocabulary, mini mental state cognitive
assessment, age, age at onset of hearing loss, duration of hearing loss, age at implantation, better-ear residual
PTA, or whether the patient used a single CI in the right, left or both ears or with a hearing aid in the
nonimplanted ear. CI users performed worse than NH on word recognition and discrimination of the sa-sha
spectral cue and the falling glide stimuli. Less than half of the 30 CI users could reliably perform the sa-sha
discrimination task. Those that could complete the spectral discrimination tasks had significantly better word
recognition than those who could not. Detection of the spectral cue of the cop-cob contrast predicted 25% of the
variance in word recognition scores, but there was no relationship to the duration cue. The difficulties of the CI
group to perform the spectral discrimination tasks and the relationship between word recognition and spectral
discrimination suggests that better representation of spectral information through CI could improve outcomes
for CI users.
Two papers investigating whether measures of electrode placement related to speech perception with a CI
found no evidence (van der Beek et al., 2016) or weak evidence (Nayak et al., 2016) of a relationship.
However, a paper attempting to measure the efficacy of the CI electrode in conveying information to the
auditory nerve found that the distance of the electrodes from the modiolus significantly correlated with evoked
compound action potentials (ECAP) (DeVries et al., 2016). Those patients with low ECAP measures and low
behavioral thresholds tended to have better speech perception scores, indicating an indirect relationship
between electrode placement and perception.
A decreased ability to perceive pitch has been linked to poorer speech perception in CI patients. New studies
related spectral discrimination (Moberly et al., 2016), perception of the F0 of complex tones (but not pure
tones) (Goldsworthy, 2015), spectral ripple discrimination (Jeon et al., 2015), perception of dynamic spectral
cues (Donaldson et al., 2015) and pitch discrimination between electrodes (Kenway et al., 2015) to speech
perception. Frequency sweep discrimination related significantly to judging the emotional content of speech
(DeRoche et al., 2016). CI users who classified phonemes using formant dynamics, a strategy based on pitch
similar to that used by NH listeners, had similar electrophysiological responses to NH listeners (Moberly et al.,
2015). CI users who used a different strategy had different electrophysiological response patterns.
Additionally, detection of amplitude modulation (De Ruiter et al., 2015) and duration cues (Donaldson et al.,
2015) were also linked to speech perception abilities. Difficulties of CI users in perceiving interrupted speech,
speech with periodic silent gaps, was found to be due to both listening through an implant and the age of the
participants (Bhargava et al., 2016). This result was supported by a study showing that CI patients are
significantly worse at detecting silent gaps in noise than NH listeners, even after improvements due to training
(Saki et al., 2016).
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Various language-related abilities were also compared between NH listeners and CI users. A study of reading
in children who use CI found them to have poorer phoneme discrimination and identification than typically
developing children (Bouton et al., 2015). However, they used similar reading tactics, indicating that the poorer
reading ability of CI children is due to phonological processing deficits. When performing gender
identification of words and sentences, NH listeners rely on both the F0 and vocal tract length (VTL) parameters
(Meister et al., 2016). CI judgments were more ambiguous and depended more on stimulus type (words vs.
sentences). VTL cues were less utilized in the CI group. Another study assessed the neurophysiologic
discrimination of speech-related stress patterns by normal and CI children who had recently been implanted
(Vavatzanidis et al., 2016). Both groups showed significantly different response patterns to the two stress
patterns, indicating that the CI enables these speech cues to be differentially encoded.
5.3.6.2 Auditory Training
Two papers reported the results of a study training CI users on perceiving phonetic boundaries (Miller et al.,
2016a and 2016b). The first paper reported that eight hours of training done over the course of two weeks
increased discrimination of phoneme pairs (Miller et al., 2016a). The effect generalized to unfamiliar talkers.
The second paper demonstrated both behavioral and neurophysiological discrimination of the phoneme pairs of
these same subjects after training (Miller et al., 2016b). These studies support the use of auditory training to
improve speech perception of CI patients.
5.3.6.3 Tonal languages
Perception of tonal languages through a CI was investigated in four new studies (Chang et al., 2016; He et al.,
2016; Liu et al., 2015; Looi et al., 2015). Tonal languages are more difficult for CI users to perceive due to the
degraded frequency information received through the CI compared to acoustic listening through a healthy ear.
One study found that CI users required much more exaggerated pitch contours than NH listeners to correctly
identify Mandarin tones 70% of the time (He et al., 2016). NH listeners needed contours that spanned an
average of 0.4 semitones, while CI users needed 9.3 semitones on average. Speech perception was found to
improve significantly over time (up to 7 years) for pediatric Mandarin speaking CI users, with the largest
increases occurring in the first three to four years after implantation (Liu et al., 2015). Younger age at
implantation and longer duration of CI use related to significantly better speech perception. Lexical category
also influenced perception, with harder words following delayed learning trajectories compared to easier words.
Learning how to interpret the CI signal and maturation likely both contribute to the improved performance over
time. Bilingual English-Mandarin CI users performed significantly worse than NH listeners when perceiving
pitch, lexical tone, and speech in noise (Looi et al., 2015). Three bilateral hearing aid users performed better
than CI users on the lexical tone and speech in noise tasks, but not pitch perception. The amount of daily
Mandarin use related to scores on all three tests. Mandarin vowel, tone and syllable (vowel and tone combined)
perception was tested in unilateral CI and bimodal conditions (Chang et al., 2016). When the talker varied from
trial to trial, performance on tone and syllable perception was worse than when all test items were spoken by
the same talker. This effect of variability was not seen for vowel perception. Perception in the bimodal
condition was better and faster than unilateral CI for tone and syllable recognition, suggesting listening is easier
with a contralateral hearing aid. However, no bimodal benefit was seen for vowel perception.
5.3.6.4 Bilateral and Bimodal CI
Many implanted children and adults listen with two implants (bilateral CI, or biCI) or with one implant and a
hearing aid (HA) on the contralateral ear (bimodal CI). Bilateral and bimodal implants are intended to restore
binaural hearing, which is known to be beneficial to hearing in noise and sound localization. Therefore, a
number of studies tested biCI and bimodal patients on auditory perceptual tasks.
One study randomly assigned 38 CI candidates to receive either unilateral or bilateral (biCI) implantation with a
HiRes 90K implant and tested speech perception, localization and a variety of subjective measures one year
after implantation (Smulders et al., 2016). Phoneme perception in quiet and sentence perception in noise did
not differ between groups. In spatially separated speech in noise, biCI users performed significantly better
when noise was presented to the better ear. Localization ability was also significantly better in the biCI group,
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and the biCI group scored higher on some subjective measures such as the Speech and Spatial Qualities test.
The authors concluded that significant benefits are derived from bilateral implantation compared to a single CI.
The influence of the duration of interval between right and left implantations on speech perception of bilaterally
implanted children was tested (Kocdor et al., 2016). With the criteria of perception with the 2nd CI being 80%
or more of that with the 1st, children with an inter-device interval of less than 3-4 years had better outcomes.
No child with stable hearing loss whose inter-device interval was more than 7-8 years achieved this criterion.
However, those with progressive loss had better outcomes at the longer intervals, with the 80% criteria closer to
9-10 years. Therefore, the study suggests that for children whose hearing loss is stable, shorter inter-device
intervals are necessary, but those with progressive loss have more time to receive an implant that will give them
maximal benefit.
The benefit of binaural input with a CI to sound localization was investigated in four studies. Bilaterally
implanted children with some hearing experience before 3 1/2 years old were found to be better at sound
localization than those who were congenitally deaf, regardless of whether they were implanted before or after 3
1/2 years old (Killan et al., 2015). Although sound localization did not reach normal levels in this study,
another study of the development of sound localization ability by bilaterally implanted children found 2/19
children eventually localized as well as normal hearing children, and 12 came close to normal localization
(Zheng et al., 2015). After two years of bilateral CI use, most children were able to discriminate sounds from
the right and left, but more time was necessary for more fine-grained localization. Additionally, the sound
localization ability of people with normal hearing (NH), bilateral hearing aids, bimodal CI, biCI, bilateral low-
frequency hearing preservation with unilateral CI, single-sided deafness with unilateral CI, and bilateral low-
frequency hearing preservation with bilateral CI was tested (Dorman et al., 2016). All patients with CI
performed worse than the NH group, but all but the bimodal listeners were able to localize sound better than
chance, with some nearing the accuracy of NH. This result was supported by another study of sound
localization in bimodal listeners in which localization was generally poor, but better than with either the CI or
HA alone (Veugen et al., 2016a). A few patients with better aided thresholds did better on the localization task
in that study.
The interfering effect of same or different gender competing speaker on speech perception and spatial release
from masking (SRM) was investigated in bilaterally implanted CI pediatric patients (Misurelli and Litovsky,
2015). More SRM was seen in the NH children than the CI children, but speech reception thresholds for a male
speaker were higher when the competing speaker was male than female in both groups. Better performance
was seen when the two talkers were spatially separated. Additionally, this group found that SRM of speech
was variable over time in bilaterally implanted children, and performance on the SRM task was not related to
localization ability (Litovsky and Misurelli, 2016).
The addition of low-frequency acoustic information to the CI input has been shown to be beneficial to speech
perception of CI patients. This can be accomplished by adding a hearing aid contralateral to a single implant
(bimodal), by implanting the deaf ear of a patient with single-sided deafness, or by adding a hearing aid to an
implanted ear that has retained residual low-frequency hearing (electro-acoustic stimulation, or EAS).
Although most studies examining bimodal listening are performed with English speaking adults, new studies
found bimodal benefit for understanding speech in noise in children (Dincer D'Alessandro et al., 2015) and for
linguistic tone and syllable recognition in Mandarin speaking adults (Chang et al., 2016). In adult CI patients
initially given a contralateral HA, patients with better thresholds and speech perception in the unimplanted ear
were more likely to continue use of the HA a year after implantation (Devocht et al., 2015). Those with
unaided CNC scores less than 14% correct were more likely to discontinue HA use, and those with >49%
correct were more likely to continue HA use. Between these scores, CI outcomes helped predict HA retention.
However, another study gave pre-lingually deafened long-term adult CI users contralateral HAs and found
improved speech perception of 4/5 patients, despite profound hearing loss in the HA ear (Gottermeier et al.,
2016). The authors suggest offering unilaterally implanted patients a bimodal trial even if their nonimplanted
ear has no functional hearing.
Two papers found better speech perception of biCI patients than bimodal listeners. A study finding better
speech perception in noise, but not in quiet, by biCI patients was performed using a within-subject design on
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patients who self-selected to pursue biCI after bimodal implantation, presumably because they were not
receiving enough benefit from their bimodal configuration (Gifford et al., 2015). Three patients with bilateral
residual hearing significantly benefited from the addition of acoustic hearing to bilateral CI. The other paper
found benefit for biCI over bimodal when categorizing fricatives containing only on high-frequency
information unavailable to the acoustic input (e.g. /s/ vs. /sh/) (McMurray et al., 2016). All CI users, regardless
of device configuration, were relatively good at categorizing stop consonants which have some low-frequency
information.
Two papers investigating the efficacy of CI in patients with single-sided-deafness found improved perception of
speech in noise when listening with the CI (Friedmann et al., 2016; Hoth et al., 2016). Sound localization with
an implant was significantly better than without the implant, but still worse than normal (Hoth et al., 2016). CI
in SSD patients was shown to be clinically beneficial.
5.3.6.5 Pitch and Music
CI users are known to have difficulty discriminating small pitch differences. This was borne out in a study
evaluating pitch perception of CI users with and without current steering (Fielden et al., 2015). No effect of
current steering was seen in that study, but larger pitch differences (1/2 octave) were better discriminated than
smaller pitch differences (1/4 octave). Perception of temporal pitch is also difficult for CI users, and this was
parametrically assessed in a study of rate discrimination, gap detection and ranking of temporal pitch in CI
users (Cosentino et al., 2016). However, classification of sounds into musical, vocal and environmental groups
was found to be similar between CI users and NH listeners (Collett et al., 2016).
CI users were found to prefer country music excerpts that had been modified to be less complex, with fewer
instruments or vocals than the original (Kohlberg et al., 2015). NH users listening to the same excerpts through
a CI simulation (vocoded stimuli) also preferred the less complex versions (Kohlberg et al., 2016).
Additionally, CI users were found to prefer music played in anechoic environments to those with reverberation
(Roy et al., 2015). These studies suggest ways to improve the enjoyment of music by CI users.
The pleasantness of consonant and dissonant melodic excerpts were rated by CI users and NH listeners
(Caldwell et al., 2016). CI users rated all excerpts similarly pleasant regardless of their dissonance level, and
NH listeners rated increasing unpleasantness with increasing dissonance. Decreased access to pitch percepts
likely played a part in the CI users' responses. Emotional content of music and speech was also found to be
judged differently between CI users and NH listeners (Caldwell et al., 2015; Gilbers et al., 2015). NH listeners
used both tempo and mode (major vs. minor) to determine emotional content, while CI users used tempo only
(Caldwell et al., 2015). When judging emotional content of nonsense speech, CI users appeared to rely more on
pitch range than absolute pitch, while the opposite pattern was seen in NH listeners (Gilbers et al., 2015).
5.3.6.6 Programming and Sound Processing Strategies
Researchers continue to attempt to improve auditory perception through a CI by investigating different

programming and stimulation techniques. A number of experimental stimulation techniques were assessed.
Selective deactivation of electrodes was not found to improve speech perception or quality of life measures, but
did improve spectral discrimination (Bierer and Litvak, 2016; Labadie et al., 2016). Current focusing, a method
of increasing the number of stimulation frequencies beyond the number of electrodes, was found to decrease
current spread, and the direction of shift in excitation pattern was consistent with a perceived pitch change
(Padilla and Landsberger, 2016; Wu and Luo, 2016). Patients with poorer speech perception tended to benefit
more from current focusing than others (Bierer and Litvak, 2016). A perceptual extension of lower frequencies
was achieved through the Phantom electrode strategy, a current focusing method used only at the low end of the
frequency range (Munjal et al., 2015). Current spread was parametrically measured and described using a
masking technique (Cosentino et al., 2015). The interleaving of electrode channels across ears in bilateral CI
patients improved spectral resolution but not localization (Aronoff et al., 2016).
Novel programming strategies and sound processing algorithms were tested at the level of the sound processor.
Speech perception and subjective ratings of sound were compared between patients' clinically created sound
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processing program and a program generated by the patient themselves based on loudness and sound quality of
speech in quiet and noise, and noise (Dwyer et al., 2016). No differences were seen in outcomes between the
two programs, indicating that this could be a useful method in the clinic. An attempt at improving
programming of sound processors of “difficult to map” children combined three electrophysiological measures
to help predict optimal M-levels (Raghunandhan et al., 2015). A new method of balancing loudness between
the CI and HA of bimodal users did not result in significant improvements of speech perception on average, but
9/15 patients performed significantly better with one or the other of the fitting methods, indicating a need for
individualized fitting of bimodal patients (Veugen et al., 2016b). A transient noise reduction algorithm
improved speech perception of CI users in the presence of transient noises such as hammering or dishes
clattering (Dyballa et al., 2015). An algorithm used to reduce the effects of reverberation was also found to
significantly improve speech perception (Kokkinakis et al., 2015). Additionally, a method of obtaining
auditory thresholds for individual electrodes was tested and found to be as accurate as conventional methods
and requires approximately a quarter of the time (Bierer et al., 2015).
5.3.6.7 Quality of Life and Patient Satisfaction
Beyond audiological and speech outcomes, access to sound with a CI can improve a patient’s quality of life in a
variety of ways. Speech outcomes of CI users were found to relate only weakly to quality of life (QOL)
measures, suggesting other factors come into play when patients judge the quality of their life with a CI
(Capretta and Moberly, 2016). For example, mental and emotional QOL assessments significantly improved
after cochlear implantation (Contrera et al., 2016). In older adults, geriatric depression significantly decreased
after receiving a CI, and this result persisted a year later (Choi et al., 2016). Cognitive function also improved
in elderly adults receiving a CI, with some measures relating to improved speech perception (Cosetti et al.,
2016).
The patient satisfaction of Neptune users was examined in 56 patients who converted to a Neptune sound
processor from a Harmony or PSP, and 40 patients for whom Neptune was the only processor they had used
(Briaire et al., 2016). Patients were satisfied with sound quality, ease of use and wearing options of the
Neptune. Many chose the Neptune because it is waterproof (83% of new users). Most (75-80%) of the patients
who switched to Neptune from a different processor found it similar to or better than their previous processor.
In a separate study, older children who met pediatric but not adult guidelines for cochlear implantation reported
that listening to speech, the quality of sound, and spatial perception of sound was better through the CI than it
had been through HA before implantation (Vickers and Bradley, 2016).
Safety
5.3.7.1 Complications
Complication rates for cochlear implantation remain relatively low, particularly for major complications. An
account of complication rates in 280 adult and pediatric patients implanted at a Japanese clinic reported a 4%
rate of major complications, including meningitis, early-stage facial nerve palsy, dehiscence of a skin flap and
reimplantation (Ogasawara et al., 2016). The rate of minor complications was 33%, including hard and soft
device failure without reimplantation, wound inflammation, disequilibrium lasting a month or more, late-stage
facial nerve palsy, electrode facial nerve stimulation, and anything requiring conservative medical intervention.
Twelve cases in this series required reimplantation. Although the minor complication rate appears high, the
types of events included in their calculation are broader than many reports, and the authors cite a number of
studies to show that their rates are similar to others reported in the literature. Complications relating to
minimally invasive pediatric CI surgery were detailed for a cohort of 141 patients receiving 248 implants at a
US clinic (Googe and Carron, 2016). The complication rates were generally low, with an overall rate of 16.5%:
5.2% major and 11.3% minor complications. Of the 13 major complications, 7 were device failures, all of
Cochlear devices. The most common minor complications were acute otitis media and minor wound infection,
with 7 instances of each.
The complication of intra-operative CSF leak was investigated in 146 pediatric unilateral cochlear
implantations in a Delhi clinic (Vashist and Singh, 2016). Nine intra-operative CSF leaks were noted in this
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series. 5/17 cases with congenital middle ear anomalies (29%) and 4/129 cases with normal middle ear anatomy
(3%) experienced CSF leak during surgery. These rates are similar to those previously published in the
literature. Successful containment of the leak was accomplished during surgery in all cases. Complete
insertion of the electrode was possible in all cases. No dizziness, vomiting or post-operative leaks occurred,
and no migration or extrusion of electrodes was seen at follow-up. Delayed CSF leak, a rare complication was
reported in two pediatric patients, representing that center’s only experience with this complication after over
1800 pediatric implantations (Horton et al., 2016). Both cases initially had uneventful surgeries and improved
hearing outcomes. After a delay of 1 and 5 months, respectively, a CSF leak was detected near the implant site.
Both cases resolved with surgery. The implants remained in place and resumed being clinically beneficial.
Another rare complication is presented regarding a case of non-tuberculosis mycobacterial infection, the first
documentation of this rare infection in a CI patient (Lodhi and Coelho, 2015). The use of ventilation tubes was
not found to relate to increased infections in a group of 506 pediatric CI patients (Javia et al., 2016).
5.3.7.2 Electrode Misdirection and Migration
Two papers advocate for the use of intraoperative x-ray to detect misplaced electrodes so that they can be
repositioned or replaced during surgery and not require a separate revision surgery (Hassan et al., 2015; Khater
et al., 2015). Cases of 5 CI patients with misdirected electrodes are discussed, with one instance detected
during surgery with intraoperative x-ray (Hassan et al., 2015). ECAP responses were not found to reliably
identify misplaced electrodes (Khater et al., 2015).
Electrode migration of 27 patients bilaterally implanted with perimodiolar arrays between 1999 and 2014 was
investigated (Mittmann et al., 2015). No clinical complaints were given by any of the patients, but seven
migrations were discovered (26%), with 4 intrusions and 3 extrusions ranging from 16 to 72 degrees. None of
these patients complained of vertigo, tinnitus or speech perception difficulties. No further intervention was
reported.
5.3.7.3 Tinnitus / Vestibular Function / Facial Nerve Function
Previous reports have shown that cochlear implantation can alleviate and sometimes eliminate debilitating
tinnitus. A new study of 64 patients with tinnitus found that a majority of patients saw a decrease in the
severity and duration of their tinnitus after implantation (Greenberg et al., 2016). Another study of 38 patients
unselected for tinnitus found that 42% had tinnitus pre-implantation (van Zon et al., 2016). In 71-80% of these
patients, tinnitus had decreased 1 year after implantation, with some achieving complete tinnitus suppression.
A minority of these patients had no change or an increase in tinnitus symptoms after implantation. Of the 22
patients with no tinnitus before implantation, 6 had tinnitus after implantation, with 2 moderate, 1 mild and 2
slight severity (one not mentioned). Therefore, although CI often suppresses tinnitus that was present before
implantation, there is a risk of developing tinnitus after implantation.
The vestibular system and facial nerves are located very close to the surgical site of cochlear implantation. A
study assessing vestibular function after implantation of 25 adults found that 4 reported dizziness or vertigo
after implantation, one with nystagmus (Meli et al., 2015). These symptoms improved with no treatment after a
few days. Although some tests of vestibular function were worse after implantation, patients had good control
over their equilibrium, suggesting central vestibular compensation corrects for some vestibular disturbance
caused by surgery. The function of facial nerve and blink reflex pathways in adult patients with unilateral
cochlear implants was investigated (Edizer et al., 2016). None of the patients in this series had any related
complaints, and functioning of the peripheral aspect of the facial nerve was found to be normal on implanted
and non-implanted sides. Responses consistent with injury to the ramus occipitalus nerve were seen on the
implanted side, likely due to surgical incision, but these decreased responses were asymptomatic. Increased
responses of the blink reflex were seen on the implanted side, suggesting increased excitability of the facial
reflex circuit after implantation, even if no symptoms are present.
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5.3.7.4 Reimplantation
One reviewed study describes surgical and audiologic outcomes of a series of 38 patients undergoing
reimplantation surgery (Manrique-Huarte et al., 2016). Of 962 patients implanted during the test period, 26
(2.7%) were reimplanted, with 12 more patients referred from other centers. Patients spanned the age range
from 1-87, with a mean of 20 years old. Reasons for reimplantation included technical failure (58%, with 11
hard and 11 soft failures), and medical complications (42%). In 8 cases the reimplantation was inserted deeper
than the initial implantation, all in patients reimplanted for medical complications, with half of them due to
initial improper placement, and the rest due to electrode migration. Pure tone threshold averages (PTA) before
complication and after reimplantation were compared, with 44% improved, 11% unchanged, and 44%
worsened 12-19dB. On speech perception tests, 64% improved, 9% did not change and 27% worsened, with
better results associated with reimplantations due to medical complications. The authors conclude that
reimplantation surgery is safe and effective, with depth of insertion and speech perception outcomes improving
in the majority of cases.
5.3.7.5 Hearing Preservation
The preservation of low-frequency acoustic hearing has been shown to improve CI outcomes, and surgical
techniques have been developed to improve the chances of retaining acoustic hearing after implantation. This
was shown in a study of babies implanted before the age of 2, in which vowel discrimination was significantly
related to the amount of residual hearing measured after implantation (Phan et al., 2016).
Hearing preservation and speech perception outcomes of 39 adult ears implanted with the AB HFMS electrode
were recently described (Hunter et al., 2016). Of the 32 with postoperative assessment at activation, 14 (44%)
maintained aidable hearing defined as <=85 dB threshold at 250 Hz. Of the 20 ears with data at 6-month
follow-up, 6 (30%) had aidable hearing. Of the 14 ears tested at 1-year follow-up, 4 (30.8%) had aidable
hearing. When looking only at those with better hearing preoperatively, 75% had aidable hearing a year after
implantation. These rates are similar to other recent studies in the hearing preservation literature. Age, surgical
approach and steroid use were not related to these outcomes. Significant improvements on speech perception
tests were seen using CI-only compared to pre-operative levels. When listening with the CI only, there were no
differences on speech tests between those with or without any aidable residual hearing. Similarly, within the
group who retained some aidable hearing, speech scores did not differ between those with more or less residual
hearing. Scores increased when listening bimodally.
In patients whose residual hearing is initially preserved, some decline in hearing may be seen over time (Dedhia
et al., 2016; Sweeney et al., 2016). This loss may be a mixed loss or sensorineural hearing loss (Dedhia et al.,
2016). Surgical and demographical factors including depth of insertion, age of patient, charge density, pre-
operative PTA, sex, tobacco use, noise-induced hearing loss and steroid use were found not to relate to the size
of the PTA shift over time, but styleted electrode arrays related to larger PTA shifts than lateral wall arrays
(Sweeney et al., 2016). The initial PTA loss after implantation was less if the patient used perioperative or
postoperative oral steroid tapers.
5.3.7.6 Cochlear Trauma
The delicate structures within the cochlea may be damaged by insertion of the electrode array, reducing post-
operative residual hearing. Electrode arrays and surgical techniques have been designed to minimize cochlear
trauma. A study of the atraumaticity of the AB HiFocus MidScala (HFMS) electrode array imaged 8 temporal
bones implanted with this array (Dietz et al., 2016). No cochlear trauma was seen. All electrodes were located
within the scala tympani, with most located in the middle of the duct, although a few of the measurements
indicated the electrode array was close to or touching the side. The HFMS was found to reside in the intended
space post-operatively and did not cause cochlear trauma. In a separate study, scalar location, electrode type
(lateral wall, mid scala, perimodiolar) and insertion depth of a variety of electrode arrays were investigated as
factors affecting residual hearing outcome of CI surgery (Wanna et al., 2015). Functional aidable hearing was
defined as less than an 80 dB hearing threshold at 250 Hz. 38/45 electrodes were successfully implanted within
the scala tympani, with 6 crossing into the scala vestibuli and 1 implanted in the scala vestibuli. A significant
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effect of scalar placement on hearing preservation was found, with 22 of the 38 with full insertion into the scala
tympani retaining functional hearing, compared to none of the 7 other patients. No other factors significantly
related to hearing preservation outcomes: age at implantation, depth of insertion, side of implantation, electrode
type, cochlear approach and sex. Some researchers attempted to predict the degree of post-operative residual
hearing with intra-operative electrocochleography (ECoG), however it did not generally relate to post-operative
hearing thresholds except in the most severe cases of complete hearing loss (Adunka et al., 2016; Dalbert et al.,
2015).
5.3.7.7 Surgical issues
A case study describing the surgical procedure and outcome of the first AB HiFocus Helix electrode array in
Brazil reported no complications and expected auditory outcomes (Castilho et al., 2015).
Clinically collected CT scans of children whose CI receiver/stimulator (RS) had been secured with the
subperiosteal pocket technique were assessed for bone thickness under the RS which was then compared to
bone thickness on the unimplanted contralateral side (Turanoglu et al., 2016). CT scans were taken between 1
and 3 years post-implantation, with the major indication of head trauma. Evidence of the formation of a bony
well for the RS was seen, supporting the claim that implants secured using the pocket technique become more
stable over time due to bone growth around the RS. Additionally, the safety of using the tailed Palva flap
method when performing subperiosteal pocket technique for cochlear implantation was reviewed in a series of
280 patients (Orhan et al., 2015). No intracranial complications or migration of the receiver/stimulator were
found. Eight patients (3%) required reimplantation, including one case (0.4%) of local flap failure and
infection. The other 7 reimplantation cases were for causes unrelated to the flap area. The authors conclude
that the tailed Palva flap is a safe and reliable surgical method.
Another paper briefly describes a new surgical technique used in creating a cochleostomy for CI insertion that
facilitates insertion of the implant, thus decreasing the possibility of cochlear trauma (Zarandy et al., 2016).
The authors state that no surgical complications occurred in any of the 306 surgeries and that all electrodes
were fully inserted. The cochleostomy approach was used in 221 cases, and no problems were encountered in
191 of these cases. No further information is given, but this implies there may have been unspecified problems
in the remaining 30 cases. No other safety or hearing preservation outcomes are described.
5.3.7.8 MRI
Two studies investigated the safety of cochlear implants in magnetic resonance imaging (MRI) (Grupe et al.,
2016; Young et al., 2016). A study of the safety and utility of 19 1.5 T MRI scans of 12 pediatric and young
adult CI users included an assessment of complications caused by scanning and whether image artifact
obscured relevant structures (Young et al., 2016). In 2 cases the CI magnet was removed. All patients received
a compression head wrap before scanning, but it is not clear whether the recommended solid shim was placed
over the implanted region between the bandage and the head to increase magnet stability. Artifact was seen in
all 8 brain scans and 1 of the upper cervical spine. All scans except one were clinically useful. Four
complications were reported. One scan caused the magnet to displace from its housing and required surgical
replacement of the magnet. Two caused magnet polarity reversal, successfully resolved by reversing the
polarity of the magnets in the external headpieces so that they would continue to affix to the internal magnet.
Magnet strength decreased after one of the scans, and was effectively treated by increasing the strength of the
magnet in the external headpiece.
Questionnaires were sent to CI patients implanted at a German clinic to determine if they experienced MRI
scanning with their implant, what preventive measures were taken, and whether there were any complications
associated with the scanning. 20/204 (10%) respondents had MRI scans, some more than one, with a total of 33
scans reported, a prevalence of 16%. Approximately half of these scans were of the head. Only 20/33 scans
included head bandaging to help keep the magnet in place during scanning. It was not known whether these
bandages included the recommended solid shim over the implant. No magnets were removed in any case.
Patients experienced pain or discomfort during 23 scans, with 2 scans stopped for this reason. The ten scans in
which no pain or discomfort was noted were all performed with head bandaging. All 13 scans performed
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July 31, 2017
without precautionary bandaging caused pain. Three magnet displacements occurred, one despite bandaging.
One was fixed through manual repositioning, the other two required revision surgery. Four patients lost
hearing through the implant after scanning, with 2 due to magnet displacement, and 2 due to sound processor
problems. It is unknown whether these sound processors were removed before scanning as required. Pain /
discomfort was the most frequent complication reported. Head bandaging reduced the incidence of pain but did
not eliminate it. The fact that 40% of the scans were performed without any precautionary measures taken
suggests radiologist training needs to be improved in this area.
Literature Review – Therapeutic Options by Indication
This literature review discusses alternative therapies to cochlear implantation for cochlear implant (CI)
candidates with different types of hearing loss: bilateral severe to profound sensorineural deafness, unilateral
severe to profound sensorineural deafness with normal hearing in the opposite ear (single-sided deafness, SSD),
unilateral severe to profound sensorineural deafness with milder hearing loss in the opposite ear (asymmetric
hearing loss, AHL), and severe to profound sensorineural hearing loss in the high frequencies with some
residual hearing in the lower frequencies (ski-slope hearing loss) . Audiogram ranges for these three profiles
are included below. Because the review focuses on therapeutic alternatives for CI candidates, these patients
must meet other CI candidacy criteria, such as no deafness due to lesions of the acoustic nerve or central
auditory pathway, no cochlear malformation or ossification that prevents electrode insertion or absence of
cochlear development. Additionally, patients must have had limited or no benefit from a trial with
appropriately fitted hearing aids. Treatment alternatives for bilateral sensorineural deafness are discussed first,
followed by alternatives for SSD and AHL, and finally for ski-slope hearing loss.
Audiological indication for bilateral sensorineural hearing loss
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Audiological indication for unilateral sensorineural hearing loss (SSD)
Audiological indication for asymmetric sensorineural hearing loss (AHL)
Audiological indication for high-frequency sensorineural hearing loss
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5.3.8.1 Bilateral sensorineural hearing loss
The literature search for therapies available to cochlear implant candidates with severe to profound bilateral
sensorineural hearing loss is an update to a review performed last August. The goal of the review is to inform
the risk/benefit analysis for cochlear implantation of these patients by determining what other treatment options
are available to them. Because the use of CI in these patients is covered comprehensively in a separate review,
this document focuses on alternative treatments only. Review articles were examined to uncover treatment
options available to this patient population. Articles reviewing only CI were excluded. Last year’s review
uncovered only two clinically available options for this population: cochlear implants (CI) and auditory
brainstem implants (ABI). All other therapies for restoring hearing were indicated for patients with milder
hearing losses or types of loss other than sensorineural. Of these two options, the literature consistently
recommended CI over ABI, and reserved ABI for those patients in whom CI is not viable, is not feasible and/or
has been attempted but failed. For example, patients without an auditory nerve would be contraindicated for CI
but could receive an ABI. This recommendation stemmed from the consensus across groups that ABI
outcomes are more unpredictable and generally worse than CI outcomes.
The current review update did not uncover any new treatment options for patients with severe to profound
bilateral sensorineural hearing loss. Only one new relevant paper was discovered, a guidance document
published by the American Academy of Audiology outlining clinical practice guidelines for treating pediatric
hearing loss (Ching et al, 2013). Although it was published in 2013, it was found using an alternative search
not used in the original review, and is included here because it is the most recent guideline discovered for the
pediatric population. The paper outlines best practices for pediatric amplification using an evidence-based
method, combining a systematic review of the literature with clinical expertise. The only option discussed for
children with bilateral severe to profound sensorineural hearing loss is cochlear implantation. They recommend
that children with one CI and residual hearing in the opposite ear should receive bimodal stimulation, a hearing
aid in the non-implanted ear, to provide binaural stimulation. The guidelines recommend bimodal stimulation
even if the residual hearing in the opposite ear is limited to frequencies at or below 500Hz, and state that there
may be benefit even with hearing thresholds between 80 and 100 dB HL.
This review update does not change the conclusions of the previous report, that CI is the treatment of choice for
patients with bilateral severe to profound sensorineural hearing loss. The only other treatment option available
to this patient group is the ABI. However, ABI is recommended only in specific cases in which CI is
contraindicated because ABI outcomes are generally considerably poorer and more unpredictable than CI
outcomes.
5.3.8.2 Single-Sided Deafness and Asymmetric Hearing Loss
A second literature search looked to discover alternative therapies available to CI candidates with severe to
profound unilateral sensorineural deafness and either normal hearing in the better ear (single-sided deafness,
SSD) or milder hearing loss in the better ear (asymmetric hearing loss, AHL). Adults with SSD must have
postlingual deafness to be CI candidates. The use of CI in SSD patients is covered comprehensively in a
separate review. Review articles were examined to uncover alternative treatment options available to this
patient population, and articles evaluating CI only were excluded. Seven papers were included, including two
clinical guidance documents published by the American Academy of Audiology outlining evidence-based
recommendations for treating pediatric and adult SSD patients (Ching et al., 2013; Valente et al., 2015). These
two papers combine a systematic review of the literature with clinical expertise.
Although SSD historically has not been treated due to access to hearing through the hearing ear, it is now clear
that unilateral deafness has significant consequences to academic, psychosocial, speech and language abilities.
Additionally, when listening with only one ear, people have difficulty localizing sounds and understanding
speech in noisy situations. Current clinical guidelines recommend providing binaural access to sound as early
as possible to avoid abnormal reorganization of the auditory system and associated developmental and
academic delays (Gordon et al., 2015, Ching et al., 2013). In addition to cochlear implantation of the deaf ear
(Braun et al., 2014; Gordon et al., 2015; Valente et al., 2015), two types of alternative therapies are available
for SSD: those that use air conduction, and those that use bone conduction.
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Air conduction devices called Contralateral Routing of Signal (CROS) receive sound from the deaf ear and
send it to a device that presents it to the contralateral ear so that sound from both ears is processed by the
hearing ear. These devices are recommended for both children and adults with SSD (Ching et al., 2013; Doshi
and McDermott, 2015; Gordon et al., 2015; Peters et al., 2015; Valente et al., 2015). They are contraindicated
in patients with extremely narrow ear canals because the device could occlude the better ear. The use of FM
systems routed to the better ear is also recommended for this group, particularly in classroom settings, as a way
to increase the signal to noise ratio (Gordon et al., 2015; Ching et al., 2013).
Bone conduction devices such as the bone-anchored hearing aid (BAHA) convert sound from the deaf ear to
vibration that is transmitted through the bone to the opposite cochlea. All reviewed papers indicated bone
conduction devices for pediatric or adult patients with unilateral severe to profound sensorineural hearing loss
(Braun et al., 2014; Ching et al., 2013; Crowson and Tucci, 2016; Doshi and McDermott, 2015; Gordon et al.,
2015; Peters et al., 2015; Valente et al., 2015). One paper noted that this option is controversial for use in
children but did not elaborate on reasons (Gordon et al., 2015). Unlike the CROS system that can be altered to
work in the case of hearing loss in the opposite ear (BICROS), bone conduction devices require normal hearing
in the opposite ear and therefore should not be used if progressive hearing loss is suspected to occur in the
better ear. Bone conduction devices require a surgery to implant the device into the skull. The original design
has an abutment that protrudes from the skin where an external processor can be attached. Newer designs offer
a transcutaneous option in which nothing protrudes from the skin, and the processor attaches magnetically to an
implant located under the skin. It is recommended that a trial with a bone conduction device be performed by
wearing the device on a headband to assess the device’s benefit before undergoing surgery (Braun et al., 2014;
Doshi and McDermott, 2015; Valente et al., 2014). The skull must be thick enough to support the implant, and
therefore young children are not eligible for this implantation but may use the device secured by a headband
until their skull thickness increases sufficiently (Braun et al., 2014; Ching et al., 2013; Doshi and McDermott,
2015). A bone conduction device that attaches to the teeth instead of the skull is mentioned as an alternative
therapy for SSD, but this device is no longer available (Valente et al., 2015).
Only two reviewed papers discussed treatment of asymmetric hearing loss (AHL), the guidance documents
published by the American Academy of Audiologists (Ching et al., 2013; Valenti et al., 2015). Two options are
presented: Bilateral contralateral routing of the signal (BICROS) and bimodal CI. For both BICROS and
bimodal CI, a hearing aid is fit in the better ear. In the case of BICROS, the signal from the deaf ear is routed
to the better ear, as described for CROS, and a hearing aid in the poorer ear processes sound from both sides.
In the case of bimodal CI, both left and right auditory systems are stimulated, one with a CI and one with a
hearing aid, creating true bilateral auditory stimulation.
For both SSD and AHL, all therapeutic options aside from CI send sound from the deaf ear to the better ear and
therefore do not provide true binaural stimulation. Instead, a single ear processes sound from both ears. CI is
the only available therapy that provides true binaural stimulation which is important for sound localization and
processing speech in directional noise. In a review of studies comparing CROS to bone-conduction devices,
speech perception outcomes were mixed, with best performance seen in CROS, bone conduction devices, or
even unaided conditions in different studies (Peters et al., 2015). No study found an advantage for sound
localization or quality of life with either device, but significant subjective benefit was seen for both devices.
Cochlear implant candidates with SSD or AHL as defined above have alternative therapies available to them
such as CROS, BICROS, and bone-conduction devices. Each therapy has distinct inclusions and exclusions to
their candidacy criteria, and different options may work better for some patients than others. Additionally, each
therapy has distinct risks and benefits. Bone conduction devices and cochlear implants require surgery while
CROS devices do not. Bone conduction devices cannot be implanted in young children, require normal hearing
in the contralateral ear and cannot be altered to deal with future hearing loss. Only cochlear implants provide
true binaural hearing, allowing bilateral stimulation of the auditory system. Binaural stimulation can prevent
abnormal reorganization of the auditory system that occurs with monaural stimulation, allows sound
localization and enhances speech perception in noise. In the case of hearing loss in the unimplanted ear,
bimodal CI stimulation can be achieved with the use of a hearing aid in that ear. Therefore it is incumbent upon
the clinician to determine through clinical testing and device trials the option best suited to an individual.
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5.3.8.3 High-frequency Hearing Loss with Residual Low-frequency Hearing (ski-slope hearing
loss)
Patients with severe to profound high-frequency sensorineural hearing loss who meet CI candidacy
requirements are eligible for electro-acoustic stimulation (EAS), meaning a CI stimulates the higher frequencies
electrically while an integrated hearing aid component provides acoustic stimulation for the lower frequencies.
Frequency lowering hearing aids (FLHA) are an alternative option for these patients. No other alternatives to
cochlear implantation were discovered for patients with severe to profound high-frequency sensorineural
hearing loss who met the candidacy requirements for EAS. FLHAs take the information from higher
frequencies which the patient cannot hear and translate or transpose that information into lower frequencies that
the listener can hear. There are a number of methods used to accomplish frequency-lowering in hearing aids,
and this technology as well as possible reasons for variability in outcomes is reviewed in Alexander, 2013.
Guidelines for pediatric amplification published by the American Academy of Audiology point out that
although high-frequency hearing is important for listeners of all ages in distinguishing speech, it is even more
important for children because they spend a substantial amount of time listening to the speech of women and
other children, which has a higher frequency content than that of men (AAA, 2013). Children who have poor
audibility in the higher frequencies are at risk of deficits in speech learning and production. The AAA
guidelines state that children with hearing loss benefit significantly from the audibility of higher frequency
speech sounds, and that FLHA may be beneficial for some children with high-frequency hearing loss who do
not benefit from conventional amplification of these frequencies.
The two reviews of FLHA included in this report describe variable outcomes of FLHA in pediatric and adult
patients with severe to profound high-frequency sensorineural hearing losses (Alexander, 2013; McCreery et
al., 2012). The reviewed studies in both papers mainly included patients with lesser hearing losses than relevant
for the present review, but also included studies of patients whose hearing loss was in the severe to profound
range in the higher frequencies with some residual hearing in the lower frequencies. These studies reported
generally poor results of FLHA in this population. When noted, improvements due to FLHA were largely
confined to fricatives (e.g. “s” and “sh”) in restricted linguistic context. Some patients showed no difference in
perception with FLHA, and a few experienced worse speech perception with FLHA. Challenges in providing
improved access to high-frequency information through FLHA were discussed relative to the inherent distortion
of the sound signal in this technique in Alexander’s review. In FLHAs, high-frequency information in the
sound signal is presented to a lower frequency region, thus making high-frequency sound audible to the patient
with high-frequency hearing loss. This distortion of the sound spectrum is intended to enhance the information
audible to the patient. However, presenting high-frequency information to lower-frequency ranges is not a
natural signal and may interfere with the processing of low-frequency information. For patients with greater
hearing loss, more severe distortions must be applied to make the high-frequency sounds audible, thus
increasing the risk that the resulting signal will be unintelligible. Many factors likely contribute to the amount
of benefit provided by FLHA, including the frequency above which high-frequency sounds are lowered, and the
severity of hearing loss in the regions to which the higher frequencies are moved. However, both review papers
conceded that it is yet unknown how to determine which patients will benefit from FLHA and which will not.
For patients with severe to profound high-frequency sensorineural hearing loss who retain some low-frequency
hearing, FLHAs are unlikely to provide much benefit. EAS is the only remaining option for providing these
patients sound stimulation beneficial to the understanding of speech.
The cumulative data provided in this CER demonstrates the Naída products achieve their intended
performances, including any direct or indirect medical effects on users as well as the clinical benefit for the
patients. Clinical performance was demonstrated in the original FEP clinical study, supported by bench data
and then reaffirmed in the literature provided in this CER. Together these data are sufficient clinical evidence to
recertify the Naída products on Cert 022.
The literature search yielded no new risks or safety issues. For the intended performance, providing speech
understanding, it is clear from the literature that the Naída products provide this performance and they continue
to be suitable for this use. Evaluation of benefits is possible based on available data. There are no limitations or
Page 91 of 96
July 31, 2017
gaps in the data, uncertainties or unanswered questions or assumptions. In addition to the literature and
postmarket data, the MDR database search in the US described below in Section 5.6.2 also determined there
were no new risks or previously unreported side effects related to Naída products. The Naída products and the
HiResolution Bionic Ear System have a well-characterized safety and performance profile.
The scope of this submission is to recertify the Naída products on Cert 022. The side-effects presented in the
labeling have not changed since the last TÜV review. The risk assessment confirmed that there is no
unacceptable risk associated with any Naída product and any residual risks have been reduced as far as
possible. The AB postmarket data shows that there have been no adverse events associated with any product on
Cert 022. There are no recalls and no FSNs during the certification period. The complaint data shows that the
RMA complaint rate is stable – from less than 1% to between 4-5% as of May 2017.
The postmarket information characterizes the Advanced Bionics product performance. The literature qualifies
the nature, severity and frequency of potential undesirable side-effects from AB products as well as competitor
products or other treatment options. The volume of clinical data from the literature provided in this CER is
extensive and contains sufficient information to guarantee the scientific validity of the conclusions relating to
undesirable side-effects and the performance of the Naída products. The MDR database search in the US
described below in Section 5.6.2 also determined there were no new risks or previously unreported side effects
related to Naída products. Incidence, cause and severity of side effects will be monitored through postmarket
activities.
Postmarket Surveillance Methods
Advanced Bionics conducts global postmarket surveillance on all products throughout the product lifecycle
through the use of multiple methods. Postmarket surveillance may include a number of strategies, in addition to
complaint handling and vigilance. These additional strategies include but are not limited to:
 Active supervision by customer surveys

 Inquiries of users and patients
 Literature reviews
 Post Market Clinical Follow-up Studies
PMCF Plan
For the cochlear implant industry, most system components do not require an in-depth analysis as the system
design, materials and surgical techniques are mature and stable. All approved cochlear implant companies have
the same system architecture which consists of a cochlear implant which is powered by an external system. The
sound processor consists of a microphone which receives the acoustic information, an electronics assembly
which converts to the acoustic information into a digital signal, and a headpiece assembly. This system
architecture has remained unchanged for over 30 years.
The Naída products already have up to 4 years of clinical use. Clinical performance is already demonstrated in
the literature described in this section of the CER, in addition to the initial premarket clinical investigation of
the front-end features reported in Appendix 6. This data affirms the original performance presented in the
bench data and literature provided in the initial submissions.
The PMCF Development Plan will ensure that PMCF is conducted, as necessary, when post-market
surveillance is not sufficient for monitoring of the device, e.g., to address the issue of underreporting of adverse
events. This PMCF plan is created for the Naída CI processor family (Naída CI Q30, Naída CI Q 70 and Naída
CI Q90). These processors have been CE-marked since March 2013 and November 2015, respectively.
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The purpose of this plan is to ensure that there are sufficient post-market activities to demonstrate the long-term
safety and performance of the Naída CI processor family. This plan is prepared in accordance with MEDDEV
2.7/1 Rev 4:2016 and MEDDEV 2.12/2 Rev 2:2012. In the development of this plan, many of the Advanced
Bionics quality system elements have been taken into consideration.
This PMCF plan is intended to perform the following:
 Detect any rare or complications or problems that may have developed after long term use or arisen in a
larger patient population
 Evaluate the residual risks identified through the risk analysis process
 Identify and evaluate any new or increased long term risks which develop through use of the device
 Provide a structured process and plan for the assessment of post market clinical data including
incorporation into the risk analysis process
 Provide a tool for the re-evaluation of the benefit/risk ratio provided by the device
 Document the type of clinical data required to demonstrate long term safety and performance
 Document if a PMCF study is required to support long term safety and performance
In order to determine if a prospective clinical investigation is required to demonstrate safety and performance,
many factors must be taken into consideration. As the Naída CI processor family has been commercially
available for some time, a significant body of peer reviewed literature exists that describes the efficacy and
safety of these processors. In addition, over 95,000 Naída CI processors have been distributed to the market
globally. As of May 2017, the complaint rate for the Naída CI processors ranges from 2-5%.
As part of the Advanced Bionics quality system, the safety and performance of the device is evaluated through
reliability leadership team, the annual review and update of the risk analysis. As part of the risk analysis life
cycle, all reported adverse events and failure modes are evaluated and included in the risk analysis updates. The
residual risk for all events is updated and evaluated to determine if any additional action is required.
In order to account for the fact that complaints may be underreported, an annual evaluation of the reported
adverse events to the United States Food and Drug Administration (FDA) is performed. This evaluation
reviews the reported events and causes from all approved cochlear implant manufacturers. A condition of
FDA’s premarket approval is that all global adverse events are reported to the FDA. The evaluation confirms if
any new cochlear implant related risk has been reported, if there is a change to the residual risk of any
Advanced Bionics device, and if there is a new failure mode or cause which could be related to a cochlear
implant.
This annual evaluation is an important tool as it represents reported adverse events from all surgeons and health
care providers, not just those who implant one manufacturer or the other. As the FDA MAUDE database
contains reports from all manufacturers, we can identify risks or causes irrespective of patient or health care
professional across the industry. The table below summarizes the results of our annual industry wide adverse
event review. This review shows that there have been no new risks associated with an Advanced Bionics device
in the last five years. The reports for the last five years can be found in Appendix 8. A summary is provided in
Table 19.
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Table 19: MDR Report Summary

Year Risk Identification Total Advanced Cochlear Medel
MDR’s Bionic Corp. MDR Rate
Filed MDR Rate MDR Rate (% of Total)
(% of Total) (% of
Total)
2016 No new AB risks 2362 16.1 45.5 38.5
No new industry risks
2015 No new AB risks 3098 20.7 57.3 21.8
2014 No new AB risks 2605 20.9 59.8 19.1
2013 No new AB risks 2800 20.3 64.1 15.5
2012 No new AB risks 3192 20.6 64.8 14.4
1 new root cause found with
a competitor’s device
PMCF Proposal
The objective of the PCMF process is to address any specific safety or performance questions that may have
arisen through the risk management process, clinical evaluation, and literature review and to address any
identified residual risks.
Advanced Bionics intends to conduct surveys of health care providers and users to confirm the long-term safety
and performance of the Naída CI processor family. This is believed to be sufficient in lieu of a formal clinical
investigation due to the wealth of efficacy and safety information available in the peer reviewed literature as
well as the large number of users and low complaint rate. The survey process will allow us to collect a large
cross sample of data of recent and long-term Naída CI processor family users.
On outline of the survey plan using questionnaires has been added to Appendix 8. A full plan will be
developed in accordance with Good Clinical Practices and ISO 14155 during the recertification process. Results
from the surveys will be incorporated into the risk analysis and standard development processes.
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CONCLUSIONS
The CER has been written based on MEDDEV 2.7.1 Rev. 4. Therefore, Advanced Bionics affirms that:
 The data confirms that the Naída products continue to comply with the AIMDD Essential Requirements
pertaining to clinical performance and safety of the device: ER1, ER2, and ER5.
 The risk/benefit profile per EN ISO 14971:2012 is acceptable for the Naída products based on the
current knowledge/state of the art, and alternative medical therapies for patients with severe-to-
profound sensorineural hearing loss or functional low frequency residual acoustic hearing profiles with
severe-to-profound high frequency sensorineural hearing loss (EAS).
 The claims for the HiResolution Bionic Ear system are adequate and substantiated for the Naída
products on Cert 022. The postmarket data, literature and updated SOTA testing data demonstrate that
the Naída products have well-established safety and performance characteristics.
 The information materials (including labeling, IFU, and promotional materials) provided are adequate
regarding device intended purpose and risk reduction measures.
 The Naída products continue to be suitable for the intended users per the labeling and usability aspects.
 There are no specific clinical concerns that have newly emerged and need to be addressed, or that could
only be addressed with a clinical study. Postmarket surveillance, including pro-active PMCF, will be
conducted to ensure on an ongoing basis that the safety and performance profile are maintained.
 There is consistency between the clinical data, information materials (including labeling, IFU, and
promotional materials) supplied, risk management documentation, and the current knowledge/state-of-
the-art.
Cumulatively, the above cited evidence supports the clinical safety and performance of the Naída products in
support of recertification under the AIMDD.
DATE OF NEXT CLINICAL EVALUATION
The date of the next clinical evaluation report will be on an annual basis following final, written approval from
the Notified Body.
DECLARATIONS OF INTEREST AND CURRICULUM VITAE
The Declarations of Interest and Curriculum Vitae for authors and evaluators associated with this revision of
the CER are provided in Appendix 9.
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DATES AND SIGNATURES
By signing this document, I declare that I have verified the contents within and find them to be adequate.
Clinical Evaluator: July 31, 2017
Andreas Buechner, PhD Date

Scientific Director of the
Hearing Center, MHH
Author: July 31, 2017
Stephanie Seidel Date

Sr. Manager, Regulatory Affairs
Advanced Bionics LLC
Page 96 of 96

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Clinical Evaluation Naída CI Q30!70!90

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Clinical Evaluation Report CER-06-A

July 31, 2017

CLINICAL EVALUATION REPORT

CER 06, Revision A

CLINICAL EVALUATION REPORT

System Device Name HiResolution™ Bionic Ear System

Product Generic Name Cochlear Implant System

Post Market Clinical Follow-up Studies/Registries ........................................................... 53

SCOPE OF CLINICAL EVALUATION – STAGE 0

AB Advanced Bionics HiRes HiResolution

Origin of Development of Naída Products on Cert 022

Identification of Naída Products on Cert 022

Table 1: Product Identification Table

Table 1: Product Identification Table

CI-5605 Naída CI - The Naída CI PowerCel™ Charger is intended to recharge

Table 1: Product Identification Table

CI-5511-xxx PowerCel™ 110 xxx The Naída CI PowerCel is a lithium-ion rechargeable

>30 days; intact

>30 days; intact

Table 1: Product Identification Table

CI-5527-xxx PowerCel™ 170 xxx The Naída CI PowerCel is a lithium-ion rechargeable

Table 1: Product Identification Table

CI-5900-100 AB myPilot - The AB myPilot is intended to function as a remote control

Table 2: Naída CI Sound Processor Specifications

– with Off-the-Ear Power Adapter 40 x 9 x 19

– with PowerCel™ 110 Mini 45 x 9 x 19

– with PowerCel™ 170 Mini 50 x 9 x 19

– with PowerCel™ 110 49 x 9 x 19

– with PowerCel™ 170 55 x 9 x 19

– with PowerCel™ 230 59 x 9 x 19

– with Zn-Air Battery Pak 53 x 9 x 19

Weight Weight in Grams

– with Off-the-Ear Power Adapter 8

– with PowerCel™ 110 Mini 11

– with PowerCel™ 170 Mini 12

– with PowerCel™ 110 11

– with PowerCel™ 170 13

– with PowerCel™ 230 13

– with Zn-Air Battery Pak 13 (includes 2 batteries)

Program Button Push-button access up to 5 programs per side for up to 10

Volume Control 10 clicks to top of volume range

Table 2: Naída CI Sound Processor Specifications

Sensitivity Selectable in software and adjustable through AB myPilot

Operating Temperature 0˚ C to 45˚ C

Humidity Range 95% (non-condensing)

Audio Sound Capture 16 bit, 96 dB

Input Dynamic Range 20 dB to 80 dB programmable

Effective Audio Sampling Rate 17.4 kHz

Automatic Gain Control Cambridge dual-loop AGC

Table 2: Naída CI Sound Processor Specifications

Table 3: AB Accessories Specifications

Table 3: AB Accessories Specifications

Sound Processing Strategies

Front End Features

Acoustic input signal into Sound Coding (SP strategy)

Figure 1: Illustration of FEP/Beamforming input signal to Sound Processing Strategy hardware/firmware

Table 4: Summary of FEP and Beamforming Features

Feature Naída Naída Naída CI Feature/Strategy Description

UltraZoom Yes Yes Yes Enhances listening when focused on a person

QuickSync Yes Yes No Bilateral hearing – one-touch control which syncs

DuoPhone Yes Yes No Bilateral hearing – Left/right ZoomControl option

WindBlock Yes Yes No This is a comfort feature. Reduces wind noise

SoundRelax Yes Yes No This is a comfort feature. Quickly adjusts sound