IFU Om-Ma42-En-2022

Operation Manual
MA 42
Operation Manual MA 42
Table of Contents
Introduction................................................................................................................. 3
1.1 Intended Use Statement ............................................................................................ 3
1.2 Indications for Use Statement.................................................................................... 3
1.3 Contraindications of Use Statement .......................................................................... 3
1.4 Description................................................................................................................. 4
For your Safety ........................................................................................................... 9
2.1 How to read this Operation Manual ........................................................................... 9
2.2 Customer Responsibility .......................................................................................... 10
2.3 Manufacturer’s Liability ............................................................................................ 10
2.4 Regulatory Symbols ................................................................................................ 11
2.5 General Precautions ................................................................................................ 12
2.6 Electrical and Electrostatic Safety ........................................................................... 12
2.7 Electromagnetic Compatibility (EMC) ...................................................................... 14
2.8 Battery Safety .......................................................................................................... 15
2.9 Device Control ......................................................................................................... 15
Warranty, Maintenance and After-Sales Service ................................................... 16
3.1 Warranty .................................................................................................................. 16
3.2 Maintenance ............................................................................................................ 16
3.3 Cleaning and Disinfection Recommendations ......................................................... 17
3.4 Disposables ............................................................................................................. 18
3.5 Accessories and Replacement Parts ....................................................................... 18
3.6 Recycling and Disposal ........................................................................................... 18
Unpacking and Hardware Orientation..................................................................... 19
4.1 Unpacking the System ............................................................................................. 19
4.2 Hardware Orientation............................................................................................... 21
4.3 Setup in a Sound Booth ........................................................................................... 22
4.4 Establishing a Connection to a PC, Printer or an External Audio Device ................ 23
4.5 Using the Printer ...................................................................................................... 24
Operating the Device ................................................................................................ 25
5.1 Getting started with the MA 42 ................................................................................ 25
5.2 Switching On the Device.......................................................................................... 26
5.3 Switching Off the Device.......................................................................................... 26
5.4 Functionality of Operating Elements ........................................................................ 26
5.5 Main Test Screens ................................................................................................... 33
5.6 Preparing for Testing ............................................................................................... 34
5.7 Testing ..................................................................................................................... 35
5.8 Managing Test Results ............................................................................................ 80
5.9 Settings.................................................................................................................... 83
Technical Data ........................................................................................................ 101
6.1 MA 42 Hardware .................................................................................................... 101
6.2 Connections........................................................................................................... 106
6.3 Pin Assignment...................................................................................................... 107
6.4 Calibration Values and Maximum Levels ............................................................... 108
6.5 Electromagnetic Compatibility (EMC) .................................................................... 118
6.6 Electrical Safety, EMC and Associated Standards ................................................ 121
6.7 Checklist for subjective Audiometer Testing .......................................................... 122
8521193 Rev. 3 1 27/04/2022

Title: MA 42 – Operation Manual

Date of issue/last revision: 27/04/2022
MAICO Diagnostics GmbH

Sickingenstr. 70-71
10553 Berlin
Germany
Tel.: + 49 30 / 70 71 46-50
Fax: + 49 30 / 70 71 46-99
E-mail: sales@maico.biz
Internet: www.maico.biz
Copyright © 2022 – MAICO Diagnostics.

All rights reserved. No part of this publication may be reproduced or transmitted in any
form or by any means without the prior written permission of MAICO. The information in
this publication is proprietary to MAICO.
Compliance
MAICO Diagnostics is an ISO 13485 certified corporation.
Caution for USA: Federal Law restricts this device to sale by or on the order of a licensed
medical professional.
8521193 Rev. 3 2 27/04/2022

Introduction
This section offers you important information about:
▪ the intended use of the device
▪ indications and contraindications of use
▪ features and benefits
▪ a description of the device
1.1 Intended Use Statement

The MA 42 is a portable or stand-alone audiometer intended to be used for the
identification of hearing loss and the factors that contribute to the occurrence of the
hearing loss in the age range of children to adults.
It is intended to be used by audiologists, ENTs, hearing healthcare professionals, or other
trained technicians in a hospital, clinic, healthcare facility or other suitable quiet
environment as defined in ANSI S3.1/ISO 8253-1 or equivalent.
1.2 Indications for Use Statement
The MA 42 is a portable two-channel air, bone, and speech audiometer. This audiometer
is used to screen, test, and diagnose hearing loss.
1.3 Contraindications of Use Statement
The patient is too young, sick or uncooperative to perform the tasks.
Features
1.3.1 General information about the MA 42
The MA 42 features the following test functions:
• Pure Tone Audiometry
• Speech Audiometry
• High Frequency Audiometry (extra license)
• Pure Tone Stenger Test
• Speech Stenger Test
• Master Hearing Aid
• SISI Test (extra license)
• Tone Decay Test (extra license)
• ABLB Test (extra license)
• MLB Test (extra license)
• Langenbeck Test (extra license)
• Freiburger Speech Test (extra Wave files)
• QuickSINTM Test (extra Wave files)
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1.3.2 Licenses
The MA 42 comes with some optional features which can be activated by entering a
license key. The License key can be added in the Settings – License Management.
Section 5.9.6 License Management

The following licenses are available:
• High Frequency – High Frequency Audiometry
• Extended Special Tests – includes:
o SISI (Short Increment Sensitivity Index) Test
o Tone Decay Test
o ABLB (Alternate Binaural Loudness Balancing) Test
o MLB (Monaural Loudness Balancing)
o Langenbeck Test
• PC Connection (for data transfer to MAICO Sessions)
1.3.3 Printing options
Printing test results from the MA 42 are accomplished in a variety of ways:
• Print test data to PDF and save report on an external USB flash drive
• Print to HM-E300 thermal printer (USB-connection) (configuration dependent)
• Print test data using PC-Software MAICO Sessions
1.4 Description
1.4.1 Air Conduction Testing
Hearing threshold levels can be determined by presenting test signals to the test subject
with the included headphones, inserts phones or speakers (Air Conduction – AC). The
purpose of AC audiometry is to establish the hearing sensitivity. The test can specify the
AC loss but cannot distinguish between a conductive versus a sensorineural abnormality.
1.4.2 Bone Conduction Testing
Hearing threshold levels can be determined by presenting test signals to the test subject with
the included bone conductor (Bone Conduction – BC). The purpose of BC audiometry is to
establish the hearing sensitivity. The test can specify the BC loss in combination with AC loss.
It can distinguish between conductive versus a sensorineural abnormality.
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1.4.3 Masking
Masking is required if there is a notable threshold difference between the left and right
ears. It is possible for sound to be transmitted to both ears via bone conduction while
testing the poorer ear. This is called crossover.
Crossover occurs often while testing bone conduction, but it can also occur during air
conduction testing. Relevant to crossover is the sound level received by the opposite ear.
The difference between the original test signal in the test ear and the received signal in
the opposite ear is called interaural attenuation.
For Bone Conduction measurements the interaural attenuation is 0 dB to 15 dB. Bone
Conduction crossover is therefore possible even with a slight difference in hearing loss
between ears.
Masking is most often performed with filtered noise signals. Narrow band noise and white
noise are available for tone tests. In speech audiometry, speech noise or white noise is
used.
1.4.4 Pure Tone Audiometry
Pure Tone Audiometry is the most important hearing test to identify a person's hearing
threshold in quiet. It helps to determine the degree and type of hearing loss and thus
provide a basis for diagnosis and further treatments.
Standard Pure Tone Audiometry measures pure tones with frequencies between 125 Hz
and 8 kHz. The hearing threshold can also be determined with warble tones and pediatric
noise. For sound field measurements it is recommended to use warble tones to avoid
standing waves. Pediatric noise is used in pediatric audiometry to maintain children's
attention. All test signals can be presented continuously or pulsed to determine hearing
threshold.
Pure Tone Audiometry is in this operation manual also referenced as Tone test or Tone.
1.4.5 Speech Audiometry
The Speech Test provides various speech audiometry tests.
The speech audiometry is a fundamental test method for assessing hearing loss.
Together with pure tone audiometry, it can help to determine the degree and type of
hearing loss. Speech audiometry is used to determine the speech reception threshold
and provides word recognition ability.
In this operation manual also referenced as Speech test or Speech.
1.4.6 High Frequency Audiometry
The High Frequency Audiometry is an extension of the Pure Tone Audiometry. It allows
to measure the hearing threshold at frequencies between 9 kHz and 16 kHz.
1.4.7 Stenger Test (Pure Tone and Speech)
The Stenger test is used to confirm the presence of unilateral pseudohypacusis. The Pure
Tone Stenger test is based on the principle that when two tones of the same frequency
are presented simultaneously to both ears, only the louder tone is perceived. The Speech
Stenger test works accordingly with speech signals.
8521193 Rev. 3 5 27/04/2022
1.4.8 Master Hearing Aid (MHA)

The MHA Test utilizes input signals from the Microphone, external audio devices
(AUX 1/2) or Wave files. The signals are then filtered to simulate the benefit of hearing
aids in the case of a high frequency hearing loss. The level of the low frequencies can be
reduced by 6 dB, 12 dB, 18 dB and 24 dB per octave.
1.4.9 Short Increment Sensitivity Index (SISI) Test
The SISI Test is a recruitment equivalent test based on the phenomenon that the
perception of level deviations is normal or increased (≤ 1 dB) for sensorineural hearing
disorders. In retrocochlear hearing disorders without recruitment the perception of level
deviations is typically decreased (> 1 dB). The test assesses the ability to detect a 1 dB
level increase from a continuous tone presented 20 dB above the pure tone threshold for
the test frequency.
1.4.10 Tone Decay Test
The Tone Decay Test is a fatigue test that examines auditory adaptation to a long-holding
pure tone. The test is used to differentiate between sensorineural and retrocochlear
hearing disorders. A tone decay or level increase of more than 30 dB indicates a
retrocochlear hearing disorder, whereas absent or a minor tone decay is present in
sensorineural hearing disorders.
1.4.11 Alternate Binaural Loudness Balance (ABLB) Test
The ABLB test is a recruitment test for loudness balance in unilateral hearing disorders.
It compares the loudness sensation of the impaired ear with the ear with normal hearing
ability at the same frequency. Complete loudness balance is achieved when equal levels
are perceived as equally loud. It is typically found in sensorineural hearing disorders with
recruitment.
1.4.12 Monaural Loudness Balance (MLB) Test
The MLB test is a recruitment test for loudness balance in bilateral sensorineural hearing
loss. It compares the loudness sensation at impaired frequencies with the ones at normal
frequencies. Complete loudness balance is achieved when equal levels are perceived as
equally loud. It is typically found in sensorineural hearing disorders with recruitment.
1.4.13 Langenbeck Test
The Langenbeck tone-in-noise test assesses the discrimination capability for different
stimuli. Through the test, the masked hearing threshold is determined, i.e., the level of a
pure tone required to discriminate the tone from masking noise while noise and tone are
presented to the same ear. The test is used to distinguish between sensorineural and
retrocochlear hearing disorders. In sensorineural hearing disorders, the discrimination
capability is preserved, and the masked hearing threshold overlaps the threshold in quiet.
The tones are heard out of the noise at the same level. In retrocochlear hearing disorders,
the perception of tone in noise is impaired and higher levels are required, so that the
masked hearing threshold is poorer than the hearing threshold in quiet. The tones are not
heard out of the noise until their levels clearly exceed the noise level.
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1.4.14 Freiburger Speech Test

The Freiburger Speech Test is used predominantly in the German-speaking world for
diagnostic purposes and in hearing aid fitting. A list of multisyllabic numbers is used to
determine the hearing loss for speech (speech level in dB for 50 % correct repeat). After
this, lists of monosyllabic words are used to determine the discrimination loss (in %) as
the difference between 100 % and the greatest possible understanding of monosyllabic
words.
1.4.15 QuickSINTM Test
The QuickSINTM test is a Speech-in-Noise test. It was developed to provide a quick
estimate of signal-to-noise ratio (SNR) loss and quantify a patient’s ability to hear in noise.
A list of six sentences with five key words per sentence is presented in four-talker babble
noise. The sentences are presented at pre-recorded signal-to-noise ratios which
decrease in 5-dB steps from 25 (very easy) to 0 (extremely difficult).
1.4.16 Test Types
1.4.16.1 General
The described test functions include several different test types. The following test types
are supported by the audiometric tests.
1.4.16.2 Hearing Level (HL)
The HL is established with the pure tone audiometry and displays the patient’s hearing
threshold in quiet. The hearing threshold is searched for at each of the different
frequencies: One method to obtain the hearing threshold is to increase the hearing level
at each frequency until the patient indicates that he hears the sound. Sinusoidal or warble
tones (frequency-modulated tones) with different frequencies are used as stimulus.
1.4.16.3 Most Comfortable Level (MCL)
Testing of MCL can be measured using pure tone stimuli or speech material. The purpose
is to determine the MCL for the patient for a given stimulus. The hearing or sound
pressure level at which the stimulus is the most comfortable is determined. This level
might be described as the level at which the patient would be comfortable listening for an
extended period of time.
1.4.16.4 Uncomfortable Level (UCL)
Testing of UCL can be measured using pure tone or speech stimuli. The purpose is to
determine the hearing or sound pressure level at which the stimuli become uncomfortable
to the patient. The UCL is described as the level between very loud and too loud as
perceived by the patient when listening to the test signal. This information is valuable for
determining the limits of a patient's dynamic range.
8521193 Rev. 3 7 27/04/2022

1.4.16.5 HL Aided (Configuration Dependent)
To verify the hearing aid fitting, the hearing threshold also can be assessed in sound field
with hearing aids (aided). For obtaining aided hearing thresholds the same methods can
be used as for the determination of the HL.
1.4.16.6 Speech Recognition Threshold (SRT)
The SRT is the minimum hearing level for speech at which a person can recognize 50%
of the speech material. Speech recognition thresholds are typically obtained with multi-
syllabic words in each ear.
1.4.16.7 Word Recognition Score (WRS)
The WRS test is performed using a list of monosyllabic words that is presented at a level
to maximize audibility without causing loudness discomfort. The number of correct words
is determined from the number of words presented for the WRS. The WRS gives an
indication of speech comprehension.
1.4.16.8 SRT Aided and WRS Aided
To verify the hearing aid fitting, the SRT and WRS can also be determined in the sound
field with hearing aids (Aided). The same method can be used as for the determination of
SRT and WRS.
1.4.17 Level Units
The level units are explained as follows:
dB HL Hearing Level: Indicates that the sound pressure level refers to the
frequency-dependent normal hearing threshold. The hearing threshold is
defined as the softest sound that a person can detect with 50 % probability.
dB EM Effective Masking: For pure tones: Sound pressure level of noise signal
that masks the pure tone to 50 % probability of detection.
For speech signals: Sound pressure level of a speech masking noise that
masks a speech signal to 50 % probability of recognition.
dB SL Sensation Level: Indicates that the sound pressure level refers to the
measured frequency-dependent hearing threshold. E.g., 30 dB SL = 30 dB
above the measured hearing threshold.
8521193 Rev. 3 8 27/04/2022

For your Safety

▪ how to read the operation manual
▪ where to spend special attention
▪ the customer responsibility
▪ the explanation of all regulatory symbols used
▪ important cautions and warnings that have to be considered during the
whole time handling and operating your device
2.1 How to read this Operation Manual

This Operation Manual contains information pertinent to the use of the MAICO device
system including safety information as well as maintenance and cleaning
recommendations.
READ THIS ENTIRE MANUAL BEFORE ATTEMPTING TO USE THIS

SYSTEM!
Use this device only as described in this manual.
All images and screenshots are only examples and may differ in
appearance from the actual device settings.
In this manual, the following two labels identify potentially dangerous or destructive
conditions and procedures:
The WARNING label identifies conditions or practices that may

WARNING present danger to the patient and/or user.
CAUTION The CAUTION label identifies conditions or practices that could

result in damage to the equipment
The information sign displays alternative documents or

sections in this operation manual that provide more detailed
information.
NOTE: Notes help you identify areas of possible confusion and avoid potential problems
during system operation.
8521193 Rev. 3 9 27/04/2022

2.2 Customer Responsibility

All safety precautions given in this operation manual must be observed at all times.
Failure to observe these precautions could result in damage to the equipment and injury
to the operator or subject.
The employer should instruct each employee in the recognition and avoidance of unsafe
conditions and the regulations applicable to his or her work environment to control or
eliminate any hazards or other exposure to illness or injury.
It is understood that safety rules within individual organizations vary. If a conflict exists
between the material contained in this manual and the rules of the organization using this
device, the more stringent rules should take precedence.
This product and its components perform reliably only when

WARNING operated and maintained in accordance with the instructions
contained in this manual, accompanying labels, and/or inserts.
A defective product should not be used. Make sure all
connections to external accessories are snug and secured
properly. Parts which may be broken or missing or are visibly
worn, distorted, or contaminated should be replaced
immediately with clean, genuine replacement parts
manufactured by or available from MAICO.
NOTE: Customer responsibility includes proper maintenance and cleaning of the device.
Section 3.2 Maintenance
Section 3.3 Cleaning and Disinfection Recommendations
Breach of the customer responsibility can lead to limitations of Manufacturer’s Liability and
Warranty.
Section 2.3 Manufacturer’s Liability
Section 3.1 Warranty
NOTE: In the unlikely case of a serious incident, inform MAICO as well as the competent
authority in the country where the user is established.
2.3 Manufacturer’s Liability

Usage of the device in a way deviant from the intended use leads to a limitation or
termination of the manufacturer’s liability in case of damage. Improper use includes
disregarding the operation manual, the operation of the device by underqualified
personnel as well as making unauthorized alterations on the device.
8521193 Rev. 3 10 27/04/2022

2.4 Regulatory Symbols

The following Table 1 gives explanation of the symbols used on the device itself, on the
packaging and the accompanying documents including the Operation Manual.
Table 1 Regulatory Symbols
REGULATORY SYMBOLS
SYMBOL DESCRIPTION
Serial number
Date of manufacture
Manufacturer
Caution, consult accompanying documents
Warning, consult accompanying documents
Information sign (reference for more detailed information)
Return to authorized representative, special disposal required
REF Reference number
Medical Device
UDI information: (01) GTIN (Global Trade Item Number),
(11) Date of manufacture, (21) Serial number
Patient applied part type B according to IEC 60601-1
Refer to operation manual (mandatory)
Keep away from rain
Transport and storage temperature range
Transport and storage humidity limitations
Voltage transformer
Do not reuse
CE label with notified body ID
Non-ionizing electromagnetic radiation
Direct Current (DC)
ETL listed mark

Logo
8521193 Rev. 3 11 27/04/2022
2.5 General Precautions

Before starting a measurement make sure, that the device
WARNING works properly.
Use and store the device indoors only. For operation, storage
and transport conditions see Table in Section 6 Technical Data.
For operation in certain places, a recalibration may be
necessary.
No modification of this equipment is allowed.
WARNING No part of the equipment can be serviced or maintained while
in use with the patient.
Do not drop or otherwise cause undue impact to this device.
If the device is dropped or otherwise damaged, return it to the
manufacturer for repair and/or calibration. Do not use the
device if any damage is suspected.
Calibration of the device: The audiometer and the headphone
WARNING complement each other and share the same serial number (i.e.
MA1234567). Therefore, the device shall not be used with any
other headphone prior to recalibration. Recalibration also needs
to be conducted, when a defected headphone is replaced.
Uncalibrated devices may lead to faulty measurements and
may cause the examinee to be exposed to loud sounds.
Ensure that the device does not come into contact with
WARNING liquids. Should the user suspect fluids have contacted the
system components or accessories, the unit should not be
used until deemed safe by a MAICO certified service
technician.
2.6 Electrical and Electrostatic Safety
This icon indicates that patient applied parts of the device
conform to IEC 60601-1 Type B requirements.
In case of emergency, disconnect the device from the

WARNING computer.
In Case of Emergency
In case of emergency, disconnect the device from power

WARNING supply.
Position the device in such a way that it can be easily
In Case of Emergency disconnected from the power plug at any time.
Do not use the device if the mains cable and/or the outlet is
damaged.
8521193 Rev. 3 12 27/04/2022

To transfer data to a PC, establishing a PC-connection via USB is

WARNING required. To learn how to safely establish a connection see:
Establishing a Connection to a PC,

Section 4.4
Printer or an External Audio Device
This equipment is intended to be connected to other equipment
WARNING thus forming a Medical Electrical System. External equipment
intended for connection to signal input, signal output or other
connectors shall comply with the relevant product standard e.g.
IEC 60950-1 for IT equipment and the IEC 60601-series for
medical electrical equipment. In addition, all such combinations –
Medical Electrical Systems – shall comply with the safety
requirements stated the general standard IEC 60601-1, edition 3,
clause 16. Any equipment not complying with the leakage current
requirements in IEC 60601-1 shall be kept outside the patient
environment i.e. at least 1.5 m from the patient support or shall be
supplied via a separation transformer to reduce the leakage
currents. Any person who connects external equipment to signal
input, signal output or other connectors has formed a Medical
Electrical System and is therefore responsible for the system to
comply with the requirements. If in doubt, contact qualified medical
technician or your local representative.
A Separation Device (isolation device) is needed to isolate the
WARNING equipment located outside the patient environment from the
equipment located inside the patient environment. In particular
such a Separation Device is required when a network
connection is made. The requirement for the Separation
Device is defined in IEC 60601-1 clause 16.
If the device is connected to a PC (IT equipment forming a
WARNING system) assembly and modifications shall be evaluated by
qualified medical technician according to safety regulations in
IEC 60601-series.
Do not touch the contacts of the device and the patient at the
WARNING same time.
If the device is connected to a PC (IT equipment forming a
system) do not touch the patient and the IT equipment at the
same time.
The consequence of not following this warning could be a too
high leakage current to the patient.
8521193 Rev. 3 13 27/04/2022

The device is not intended for operation in areas with an

WARNING explosion hazard. Do NOT use the device in a highly oxygen-
enriched environment, such as a hyperbaric chamber, oxygen
tent, etc. If the device is not used switch it off and disconnect it
from the power supply.
Never short-circuit the terminals.
To avoid the risk of electric shock, this equipment must only be

WARNING connected to the medical power supply originally delivered by
MAICO. Using another power supply can also lead to electrical
damage on the device.
Prevent cable breakage: cables must not be bend or buckled.

WARNING
2.7 Electromagnetic Compatibility (EMC)

This device is suitable in hospital environments except for near
WARNING active HF surgical equipment and RF shielded rooms of
systems for magnetic resonance imaging, where the intensity
of electromagnetic disturbance is high.
The device fulfills the relevant EMC requirements. Avoid
unnecessary exposure to electromagnetic fields, e.g. from
mobile phones etc.
Use of this device adjacent to or stacked with other equipment
should be avoided because it could result in improper operation. If
such use is necessary, this device and the other equipment should
be observed to verify that they are operating normally.
WARNING
Use of accessories, transducers and cables other than those
specified or provided by the manufacturer of this equipment
could result in increased electromagnetic emissions or
decreased electromagnetic immunity of this equipment and
result in improper operation.
The list of accessories, transducers and cables can be found
in the Section of this instruction.
Section 6.5 Electromagnetic Compatibility (EMC)
Portable RF communications equipment (including peripherals

such as antenna cables and external antennas) should be
WARNING used no closer than 30 cm (12 inches) to any part of the MA
42, including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result
in improper operation.
8521193 Rev. 3 14 27/04/2022

2.8 Battery Safety

This device contains a coin-type lithium battery.
WARNING Batteries may explode or cause burns, if disassembled,

crushed or exposed to fire or high temperatures.
The battery cell can only be changed by service personnel.
2.9 Device Control

The user of the device should perform a subjective device check once a week according
ISO 8253-1. For annual calibration and checklist see:
Section 6.7 Checklist for subjective Audiometer Testing
Section 2.5 General Precautions
Section 3.2 Maintenance
8521193 Rev. 3 15 27/04/2022

Warranty, Maintenance and After-Sales Service

▪ warranty conditions
▪ maintenance
▪ cleaning and disinfection recommendations
▪ accessory and replacement parts
▪ recycling and disposal of the device
3.1 Warranty
The MAICO MA 42 is guaranteed for at least 1 year.
This warranty is extended to the original purchaser of the device by MAICO through the
distributor from whom it was purchased and covers defects in material and workmanship
for a period at least 1 year from date of delivery of the device to the original purchaser.
The device shall only be repaired and serviced by your distributor or by an authorized
service center. Opening the device case voids the warranty.
In the event of repair during the guarantee period, please enclose evidence of purchase
with the device.
3.2 Maintenance
In order to ensure that the device works properly, it has to be checked and calibrated at
least once every twelve months.
The service and calibration must be performed by your dealer or to a service center
authorized by MAICO.
When returning the device for repairs or calibration it is essential to send the acoustic
transducers with the device. Please include a detailed description of faults. In order to
prevent damage in transit, please use the original packing when returning the device.
8521193 Rev. 3 16 27/04/2022

3.3 Cleaning and Disinfection Recommendations

It is recommended that parts (device and accessories like headphones, ear cushions)
which come in direct contact with the patient be subjected to standard cleaning and
disinfecting procedure between patients.
Recommendations for cleaning and disinfection of MAICO device presented in this
document are not intended to replace or contradict policies in effect or procedures
required for infection control at the facility.
If there is not a high infection potential, MAICO recommends:
• Before cleaning always switch off and disconnect the device from power supply.
• For cleaning use a lightly dampened cloth with soap water solution
• Disinfect the device and its accessories by wiping the surfaces with wet disinfection
wipes and allow them to take effect for the duration related to the specific
disinfection aim listed in product data sheet of the disinfection product. Please
follow also its instructions for cleaning.
• Wipe before and after each patient
• After contamination
• After infectious patients
• Disinfect computer, keyboard, transport trolley etc.:
• once a week
• after contamination
• when polluted
To avoid damage of the device and its accessories, please mind
CAUTION
the following:
Do not autoclave or sterilize.
Do not use the device in the presence of fluid that can come into
contact with any of the electronic components or wiring.
Should the user suspect fluids have contacted the system
components or accessories, the unit should not be used until
deemed safe by a MAICO certified service technician.
CAUTION Do not use hard or pointed objects on the device or its accessories
Use 70 % isopropyl alcohol only on hard cover surfaces.
8521193 Rev. 3 17 27/04/2022

3.4 Disposables
Use only the Sanibel Supply disposable supplies that are supplied with your MA 42 system.
Foam eartips are intended for single-use only. These should be

discarded after use. They cannot be cleaned.
In case of re-use of the single-use disposables, you enhance the

WARNING
risk of cross-contamination!
3.5 Accessories and Replacement Parts

Some reusable components are subject to wear with use over time. MAICO recommends
that you keep these replacement parts available (as appropriate for your MA 42 device
configuration). Ask your authorized local distributor when accessories need to be
replaced.
3.6 Recycling and Disposal
Within the European Union it is illegal to dispose of electric and
electronic waste as
unsorted municipal waste. According to this, all MAICO

products sold after August 13, 2005, are marked with a
crossed-out wheeled bin. Within the limits of Article (9) of
DIRECTIVE 2002/96/EC on waste electrical and electronic
equipment (WEEE), MAICO has changed their sales policy. To
avoid additional distribution costs we assign the responsibility
for the proper collection and treatment according to legal
regulations to our customers.
Non-European Outside the European Union, local regulations should be

countries followed when disposing of the product after its useful life.
Batteries may explode or cause burns, if disassembled,

WARNING
crushed or exposed to fire or high temperatures.
8521193 Rev. 3 18 27/04/2022

Unpacking and Hardware Orientation

This section provides information on:
▪ unpacking the device
▪ components
▪ becoming familiar with the hardware inclusive connections
▪ how to store the device
▪ rear panel
4.1 Unpacking the System

Check Box and Contents for Damage
• It is recommended that you unpack your MA 42 carefully making sure that all
components are removed from the packing materials.
• Verify that all components are included as shown on the packing list included with
your shipment.
• If any component is missing, contact your distributor immediately to report the
shortage.
• If any component appears to be damaged in shipment, contact your distributor
immediately to report it. Do not attempt to use any component or device that
appears to be damaged.
Reporting Imperfections
Notify the carrier immediately if any mechanical damage is noted. This will ensure that a
proper claim is made. Save all packaging material so the claim adjuster can inspect it as well.
Report Immediately any Faults
Any missing part or malfunction should be reported immediately to the supplier of the
device together with the invoice, serial number, and a detailed report of the problem.
Keep Packaging for Future Shipment
Save all the original packing material and the shipping container so the device can be
properly packed if it needs to be returned for service or calibration (see Section 3.2).
8521193 Rev. 3 19 27/04/2022

The availability of configurations with the following components is country specific.

Contact your local distributor for more information.
Components
Base Unit
Power Supply UES24LCP-120200SPA
AC Headphones**
DD45*
DD65 v2*
IP30 Insert Earphone*
DD450 (High Frequency)*
BC Headphones**
B71*
B81*
BKH10 with Masking Headphones Holmco 9501*
Speaker**
SP90A
SP85A
SP90
AP70 FF Amplifier
Canton CD220
Patch Cords
Monitor Phone (for Examiner)
Monitor Phone & Microphone Headset (for Examiner)
Talk-Back Microphone (for Patient)*
Patient Response Switch APS3*
HM-E300 Printer Kit (3 Inch Thermal Printer, Includes 2 Rolls of Paper)
Carrying Case
Operation Manual
Quick Guide
* Applied Part according to IEC 60601-1
**Selection of transducer at time of purchase
Licenses
Licenses
High Frequency – High Frequency Audiometry
Extended Special Tests
PC Connection
8521193 Rev. 3 20 27/04/2022

4.2 Hardware Orientation

4.2.1 MA 42 Device
The ergonomic design of the MA 42 makes it possible to control the hearing level,
signal presentation, and frequency with one hand (Figure 1).
Figure 1
4.2.2 Rear Panel Connections
If you insert the plugs into the sockets while the device
is switched on, short-circuit damage may occur.
CAUTION Always keep the audiometer as well as external
equipment (applied parts) disconnected from power
and switched off during setting up and connecting the
device!
8 10 12 14 16
Figure 2 1 2 3 4 5 6 7
9 11 13 15
1: Power switch 9: AUX input

2: Power socket 10: Speaker left channel
3: USB out socket 11: Speaker right channel
4: USB in socket 12: Bone conduction receiver
5: Patient response switch socket 13: Insert phone left channel
6: Talk Back microphone socket 14: Insert phone right channel
7: Mic - microphone socket 15: Phone left channel
8: Monitor phone output socket 16: Phone right channel
8521193 Rev. 3 21 27/04/2022
4.3 Setup in a Sound Booth

If you connect external equipment (applied parts) to a sound
booth via a common jack panel with common grounding, this can
cause a short circuit in the device. This will lead to severe device
failure.
CAUTION
Installation should be carried out by an authorized MAICO service
technician only.
Check before use that the installation is correct (e.g. after
cleaning).
8521193 Rev. 3 22 27/04/2022

4.4 Establishing a Connection to a PC, Printer or an External Audio Device

Infection of the device or the software used with the device can
WARNING lead to system failure and data misuse.
Ensure that your PC is adequately protected against cyber-attacks.
To transfer data to a PC, establishing a PC connection via USB is required. If the MA 42

is used with office equipment that is not a medical device itself (see Table 2PC
Connection 1), make sure to establish the PC connection in one of the following ways
(see, PC Connection 2, 3 or 4).
In case an external audio device shall be connected proceed accordingly to PC
Connection 3 (if used with an external audio device with power supply) or 4 (if used with
a battery driven external audio device).
Make sure you use only office equipment with the device that
WARNING is a medical device itself or meets the requirements of
IEC 60950. If a non-medical device is used within the patient
environment (1.5 m from patient as defined in IEC 60601)
a voltage transformer must be used (exception: a battery driven
laptop is used).
Table 2 PC-Connections
PC CONNECTIONS
PC Connection 1: PC Connection 2:
Medical device – Medical device Medical device – Non-Medical device
PC Connection 3: PC Connection 4:
Medical device – Non-Medical device Medical device – Laptop (battery-driven)
8521193 Rev. 3 23 27/04/2022

4.5 Using the Printer

4.5.1 Connecting the Printer to the MA 42
The connection of the MA 42 and the thermal printer is made via USB connection.
4.5.2 Powering the Thermal Printer
The thermal printer is powered by a Lithium-ion battery.
Insert the plug of the USB cable into the laterally placed
socket and plug the other end of the USB cable into the
USB port on the device for power supply and data transfer
(Figure 3).
Figure 3
4.5.3 Insert Paper Rolls Into the Thermal Printer

The printer indicates that it has run out of paper by displaying the message "Out of paper"
on the screen and the blue LED (ERROR) flashes (Figure 4).
Open the printer by pressing the small latch button (Figure 5).
Insert the paper roll into the printer with the paper end placed towards the open cover. Hold
the paper end in place and close the cover. Turn the printer on and press the feed button on
the left side so that the printer can properly align the paper with the print head (Figure 6).
Figure 4 Figure 5 Figure 6
4.5.4 Storage
When the MA 42 is not in use, store it in a location where it will be safe from damage to
the screen or other sensitive components such as the acoustic transducers and cables.
Store according to the recommended temperature conditions described in Section 6.1.
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Operating the Device

This section offers you information about:
▪ how to get started with the MA 42
▪ the device layout
▪ the function keys
▪ performing the measurement methods of Audiometry
▪ documentation of results
▪ changing settings in the user menu
5.1 Getting started with the MA 42

5.1.1 Use of Equipment After Transport and Storage
Make sure the device is functioning correctly before use. If the device has been stored in
a colder environment (even for shorter time) allow the device to become acclimatized.
This can take a long time depending on the conditions (like environmental humidity). You
can reduce the condensation by storing the device in its original packaging. If the device is
stored under warmer conditions than the use conditions no special precaution are required
before use. Always ensure proper operation of the device by following routine check
procedures for audiometric equipment.
5.1.2 Where to Setup
The MA 42 should be operated in a quiet room, so that the audiometric examinations are
not influenced by outside noises. Ambient sound pressure levels in an audiometric test
room shall not exceed the values specified in ISO 8253 series or ANSI S3.1.
Electronic devices, which emit strong electromagnetic fields (e.g. microwaves or
radiotherapy devices), can influence the function of the audiometer. Therefore, it is not
recommended to use these devices in close proximity to the audiometer as it may lead to
incorrect test results.
The test room must be at a normal temperature, usually from 15 °C/59 °F to 35 °C/95 °F,
and the device should be switched on approximately 10 minutes before the first
measurement. If the device has been cooled down (e.g. during transport), please wait until it
has warmed to room temperature before using.
NOTE: For temperature and warm-up time see:
Section 6.1 MA 42 Hardware
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Preparation
• Place the MA 42 on a stable counter or table.
• Plug the DC power connector into the power socket on the rear panel.
• Connect all accessories with the appropriate sockets.
• Plug the power cord into a power outlet.
NOTE: A device should always be off when inserting or removing an accessory from the
rear panel connectors.
5.2 Switching On the Device

Switch on the device as follows:
• via power switch on the rear panel of the MA 42.
• Boot-up time up to 1 min.
5.3 Switching Off the Device
If you do not turn off the MA 42 when not in use, the display
CAUTION hardware might get damaged (screen burn-in).
Always turn off the device if not in use.
Switch off the device as follows:

• via power switch on the rear panel of the MA 42 or
• disconnect the power cable
5.4 Functionality of Operating Elements
The main functions of the MA 42 are directly accessible by using the function keys which
are located around the display.
Some of the function keys behave differently depending on how long they are pressed:
Quick Select Press briefly Selects directly e.g.
opens selection menu

Advanced Select Press and hold for 2 s
with all options shown
e.g.
NOTE: Buttons that have a filled arrow displayed (i.e., ▲, ►), indicate Advanced Select
is available.
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Figure 7 shows the operating elements of the MA 42, Table 3 gives explanation.
3 11 12
3
1 1
2 2
6 7
4 4
5 5
8
10 10
Figure 7
Table 3 Operating Elements
No. Key Information
1 Control Dial to select (hearing level, test, setting).
key to present/interrupt signal or masking noise (hearing level) or
2
confirm selection (test, setting)
S keys to store single results.
3
Press for 2 s to store a No Response result.
+ keys Tone test: to change to a higher frequency.
4 SRT test (Wave only): to select the next word.
WRS test: to enter a correct answer.
- keys Tone test: to change to a lower frequency.
5 SRT test (Wave only): to select the previous word.
WRS test: to enter a wrong answer.
Data
6 Table 4 Data Management
Management
7 Navigation Table 5 Navigation
8 Test Setup keys Table 6 Test Setup
9 Selection keys Table 7 Selection Keys
10 STIM keys Table 8 STIM/TALK Key and STIM/Monitor Key
11 Numerical Bar Section 5.7.3.3 Pure Tone Audiometry Screen

12 Microphone Buit-in microphone
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Table 4 Data Management

Symbol Select Function
Quick Select to print test report to the default printer.
Advanced to print test report to the selected printer ( : PDF, :
Select thermal printer).
Quick Select to delete all stored results and create a new session.
to delete all stored results and create a new session or
to erase last stored value .
Advanced If more than 1 value has been stored before a Delete point
Select
window opens. Delete a value using the Control Dial and
the key.
Table 5 Navigation
to open the Special Test Menu (Figure 8). Select a special
test using the Control Dial and the key.
Quick Select
Figure 8
Advanced
Select and press to open the Settings Menu.
to open the Speech Test List.

Quick Select NOTE: This icon is only shown if Wave files are used for
Speech Audiometry.
and press to open the Settings Menu OR

Advanced
Select
press to enter the Special Test Menu.
to switch beween Speech and Tone test.
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Table 6 Test Setup

Quick to change ears (left ↔ right channel).
Select
Monaural mode: to select ear for the left OR right channel
for monaural presentation. Selection for the other channel
stays the same.
NOTE: This function can be useful if you want to apply
Advanced different Signals (Tone, Pediatric Noise or Speech Input)
Select or Masking Noise to the same ear.
Binaural mode: to select binaural presentation: .

Binaural mode allows to store binaural symbols according
to the symbols set. For binaural presentation the same
signal, level and L&T (Lock & Track) is preselected.
Tone:
HL to select the test type.

MCL NOTE: If you want to use the HL function, you must first
UCL select Speaker as the transducer. Otherwise, the function
HL is grayed out.
Quick to change Tone , Pediatric Noise and Masking

Select
Noise (left ↔ right channel).
to select Tone , Pediatric Noise , or Masking Noise

Advanced
Select for the left OR right channel only. The selection of the
other channel will not change.
Speech:
SRT
WRS
MCL to select the test type.
UCL
SRT
WRS
Quick to change Speech Input and Masking Noise (left ↔ right
Select channel).
to select the Speech Input:

Advanced
Select • microphone
8521193 Rev. 3 29 27/04/2022

• auxiliary 1/2 e.g. CD channel 1/2
• Wave channel 1/ 2 or
• Masking Noise
for the left OR right channel only. The selection of the other
channel will not change.
Freiburger Speech Test:

Numbers
Words
MCL Quick to select the test type.
UCL Select
Numbers
Words
Quick to change Wave Input and Noise (left ↔ right channel).
Select
Table 7 Selection Keys

Selection Function
to select the transducer for the left and the right ear (only calibrated
transducers can be selected). Select:
Transducer Phones to select headphones (AC).
Insert to select insert phones or high frequency headphones (AC).
Bone to select bone conductor (BC).
NOTE: If you select Bone for one ear, the default or bone
masking transducer is automatically selected for the other
ear. By press and hold for 2 s the opposite transducer can be
changed between Phone and Insert.
Speaker to select loudspeaker for sound field testing.
NOTE: For specific transducer setup see:
Section 5.11.2 Device Information – Transducers
Tone Type Steady to select a steady stimulus.

Pulse to select pulse stimulus.
Warble to select warble stimulus.
P&W to select combined pulse and warble stimulus.
NOTE: If Pediatric Noise is selected only Steady and Pulse are
available.
8521193 Rev. 3 30 27/04/2022
to select Lock/Track functions. Select:

Lock/Track
Function Unlock to use neither the Lock nor the Track function.
Lock to lock the presentation of the signal in both channels.
Track to automatically increase and decrease channel 1 and 2
levels with the rotation of only one Control Dial.
L&T to combine Lock and Track function to assist with binaural
testing or masking (automatically selected if binaural
presentation is selected).
NOTE: If binaural presentation is selected, only Lock and L & T is available.
Table 8 STIM/TALK Key and STIM/Monitor Key

Key Select Function
Quick Select STIM: to switch between Presenter and Interrupter mode.
Talk: to open the Communication widget (Figure 9)
STIM
Talk Figure 9
Talk Forward: Allows tester to provide instruction to the
Advanced patient while the headphones are in place.
Select Increase/decrease the volume by using the Control dial
and the key. The lighted bar/VU meter allows the
examiner to monitor their voice for optimal sound quality.
When speaking, 0 is the optimal level.
Talk Back: Allows you to hear the patient through the
internal speaker or monitor headset via an optional talk
back microphone. Increase/decrease the volume or set
the function off by using the Control dial and the key.
The volume dial on the monitor headset must also be
controlled for optimal volume.
Press STIM to close the widget again.
Quick Select STIM: to switch between Presenter and Interrupter mode.

STIM
Monitor Advanced Tone Test:
Select Monitor: to open the Monitor widget (Figure 10).
8521193 Rev. 3 31 27/04/2022

Key Select Function
Figure 10
Allows you to hear the Tone and Masking Noise stimuli
through the internal speaker or monitor headset.
Increase/decrease the volume or set the function off by using
the Control dial and the Key. The volume dial on the
monitor headset must also be controlled for optimal volume.
Speech Test:
Monitor: to open the Monitor/Input Calibration widget
(Figure 11).
Figure 11
Monitor: Allows you to hear the Speech Input and
Masking Noise stimuli through the internal speaker or
monitor headset via an optional talk back microphone.
Increase/decrease the volume or set the function off by
using the Control dial and the Key. The volume dial
on the monitor headset must also be controlled for optimal
volume.
Input Calibration: Allows you to calibrate the selected
input signal by using the Control dial and the Key.
The optimal level is between -3 and 0 (green area).
Press Monitor to close the widget again.
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5.5 Main Test Screens

The MA 42 has two main test screens:
• Pure Tone Audiometry (Figure 12)
• Speech Test:
o Speech Audiometry (Figure 13) OR
o Freiburger Speech Test
NOTE: For a detailed description of the screens see:
Section 5.7.3.3 Pure Tone Audiometry Screen
Section 5.7.4.2 Speech Audiometry Screen
Section 5.7.4.7 Freiburger Speech Test
Figure 12 Figure 13
The default test screen is selected as the start screen.
NOTE: You can select the default test screen in the settings.
Section 5.9.2.1 Basic Settings – General
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5.6 Preparing for Testing

5.6.1 Placement of Headphones (for Testing with Headphones)
Eliminate any obstructions which will interfere with the
placement of the ear cushions on the ear (i.e. hair,
eyeglasses).
Ensure that the headphones (Figure 14) are positioned
correctly: red phone on the right ear, blue phone on the left
ear. Adjust the headband of the headphones so that the
Figure 14 earphones are positioned at the correct height (i.e. the
sound output grid exactly facing the ear canal).
5.6.2 Placement of Foam Eartips (for Testing with Insert Earphones Only)
The insertion of the insert phones into the ear canal without
WARNING an earplug can scratch the ear canal.
Always apply a foam eartip before inserting the insert
phones into the ear canal.
First, place the foam eartip securely on the adapter at the
end of the insert earphone tubing. To prepare the foam
eartip for insertion in the ear canal, you must compress the
foam by rolling it in your fingers to narrow its diameter
(Figure 15). Check to be sure that the foam does not
obstruct the opening of the black sound tube.
Figure 15
Quickly, while the foam is still compressed, grasp the patient’s

ear and gently pull it up and back to open and straighten the
ear canal. While holding the canal open, slide the compressed
foam ear tip into the ear canal. The foam should be completely
✓ X surrounded by the canal with virtually none of the foam sticking
out of the canal (Figure 16).
Figure 16
5.6.3 Placement of Bone Conductor (for Bone Conduction Testing)

Place the bone conduction oscillator on the patient’s head
so that the flat, circular side of the transducer is placed on
the mastoid, at the noticeable ledge of the cranial bone
behind, but not touching the pinna. The other side of the
headband is placed in front of the opposite ear (Figure 17).
Perform the test utilizing the same method as air conduction
Figure 17 testing.
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5.7 Testing
5.7.1 Test Selection
The tests are selected via the navigation keys:
• Tone Test
• Speech Test
• Special Test Menu
Section 5.4 Functionality of Operating Elements – Table 5
5.7.2 Special Test Menu

Additional tests are listed in the Special Test Menu. To navigate in the Special Test
Menu press/use:
to enter the Special Test Menu (Figure 18).
Quick
Select
Advanced
Select
Figure 18
Control dial to select a special test.
key to enter the selected special test.
to go back to the previous screen.
to directly go to Tone Test screen.
to directly go to Speech Test screen.
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5.7.3 Tone Tests
5.7.3.1 General
Pure Tone Audiometry supports the following tone audiometric test types:
• Hearing Level (HL)
• Most Comfortable Level (MCL)
• Uncomfortable Level (UCL)
• Hearing Level Aided (HL ) (configuration dependent with sound field testing)
Furthermore, the following special tests and functions can be performed:
• High Frequency Audiometry
• Pure Tone Stenger
• SISI Test
• Tone Decay Test
• ABLB Test
• MLB Test
• Langenbeck Test
NOTE: The tests are described in the following sections. See:
Section 5.7.3.4 Hearing Level (HL)
Section 5.7.3.5 Sound Field Testing (Configuration Dependent)
Section 5.7.3.6 High Frequency Audiometry
Section 5.7.3.7 Pure Tone Stenger
Section 5.7.3.8 SISI (Short Increment Sensitivity Index) Test
Section 5.7.3.9 Tone Decay Test
Section 5.7.3.10 Alternate Binaural Loudness Balance (ABLB) Test
Section 5.7.3.11 Monaural Loudness Balance (MLB) Test
Section 5.7.3.12 Langenbeck Test
Section 5.7.5.1 Most Comfortable Level (MCL)
Section 5.7.5.2 Uncomfortable Level (UCL)
8521193 Rev. 3 36 27/04/2022

5.7.3.2 Preparing the Patient
The patient should sit at a distance of at least 1 m from the device.

Prior to hearing threshold level measurements, the following instructions should be given. "You
will now hear a variety of tones with various loudness levels, raise your hand, or press
the response switch, as soon as you hear the tone in either ear.“
NOTE: This is an example of patient preparation. Each state may have their own preparation
procedure. Contact your state health department for guidelines in your area.
5.7.3.3 Pure Tone Audiometry Screen
Section 5.4 Functionality of Operating Elements
Figure 19 shows the Tone Test screen. Table 9 gives explanation of what the Tone Test
screen displays.
1
2
3
4 4
4
5 5
Figure 19
Table 9 Explanation of Tone Test Screen
No. Name(s) / Explanation
Functions
1 Status Bar Displays the Date/Time and the status of PC-connection (green
if connected to MAICO Sessions)
2 Patient An orange bar lights up if the patient gives feedback with the patient
Response response switch.
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Functions
3 Numerical The numerical bar shows the numerical data for the testing
Bar operation of the device (Figure 20).
1a 1b
2a 3a 4 3b 2b
Figure 20
The information includes:
1a/ When a stimulus is presented to the patient the small box
1b on the edge of the bar turns green.
Signal type and tone type icon (i.e. pure tone, pediatric noise)
2a/ for test ear/channel.
2b
Masking noise icon for masking of non-test ear.
3a/ Hearing level of channel, displayed in the color of the ear
3b selected (Right ear/Red, Left ear/Blue).
4 Frequency of test signal.
4 Result Results are stored on the device for review. The display can be
Display configured to One Audiogram or Two audiograms within the
settings.
Section 5.9.3.2 Tone Settings – Display
5 PTA Pure Tone Average (PTA) is automatically displayed below the

audiogram as soon as there are the required stored results
(according to the conditions set in the settings).
Section 5.9.3.5 Tone Settings – PTA
6 Masking Depending on the settings, a masking table can be displayed or

Table not. Frequencies deselected in the settings are grayed out and
cannot be controlled.
Section 5.9.3.2 Tone Settings – Display
Section 5.9.3.3 Tone Settings – Level
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5.7.3.4 Hearing Level (HL)
Section 1.4.1 Air Conduction Testing
Section 1.4.2 Bone Conduction Testing
Section 5.6 Preparing for Testing
Threshold Determination
Prepare the patient for the Testing (Air Conduction or Bone Conduction) by placing the
corresponding transducer on the patient.
The testing procedure for Air Conduction and Bone Conduction testing is the same.
Press/use:
Test setup key HL to switch to HL test type.
to select the ear(s) for the channel(s).
to select the Signal Type Tone or Pediatric Noise for

patient’s ear to be tested and Masking Noise for the
other ear if needed.
Steady/Pulse/Warble/P&W to select the Tone Type for the selected signal type.
+/- keys to set a frequency. Standard start frequency is 1000 Hz.
to select a level. You can use a procedure of “down 10

Control Dial
dB, up 5 dB” to determine the threshold.
to present/interrupt the tone signal (depending on

key whether you have selected Presenter or Interrupter
mode).
S key or to store the hearing threshold at selected level.
S key (for 2 s) to store a No Response result.
Repeat this procedure for each frequency.
Repeat the whole testing procedure for the second ear.
NOTE: The cursor within audiogram:

• + indicates the Signal level.
• - identifies Masking level. It is not possible to store a masking level in the audiogram.
NOTE: Generally, you can use either the left or the right S key for storing. Only if you set
the audiograms to display Tone for the left and right ear (special function) you must use
the left and right S keys according to the assignment to the ear.
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5.7.3.5 Sound Field Testing (Configuration Dependent)
NOTE: For sound field measurements an active loudspeaker or an amplifier/passive

loudspeaker combination needs to be calibrated to the device. When Speaker is selected,
the test type HL (HL Aided) is automatically preselected.
Press:
Selection key Speaker to select Speaker as the transducer.
Selection key Warble to select Warble or P & W as test signal (recommended for
or P & W accurate results).
Test setup key to select another Test type if needed.
Proceed with the usual Tone testing procedure.
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5.7.3.6 High Frequency Audiometry
NOTE: To use this function you must

• use a High Frequency transducer calibrated by a service technician qualified by
MAICO and
• activate the High Frequency license.
Section 1.4.6 High Frequency Audiometry
Section 5.7.2 Special Test Menu
The High Frequency test screen (Figure 21) shows an expanded audiogram view.
The left audiogram displays the values for the standard frequency range. The right
audiogram displays the values for the high frequency range (9 kHz to 16 kHz).
The values for the left and right ear are combined in the same audiogram. The values
can be distinguished by color (Red = Right, Left = Blue) and symbols.
Figure 21
The testing procedure is identical to the one in the standard frequency range.
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5.7.3.7 Pure Tone Stenger
Section 1.4.7 Stenger Test
The Pure Tone Stenger is a reduced tone test with non-changeable pre-settings:
• Binaural presentation is fixed.
• Tone is preselected as signal type in both channels. Only Tone or Pediatric Noise is
available as Signal Type.
• Lock is fixed – levels for right and left ear change simultaneously
• The default transducer is preselected. It is only possible to select Phones or Insert
as a transducer.
• Storing and Data management is not available.
The Pure Tone Stenger test screen shows the current test results of the Pure Tone
Audiometry (Figure 21).
Figure 22
How to Perform the Pure Tone Stenger
Press:
to select Tone or Pediatric Noise .

1. Instruct the patient to press the response button when the tone is heard.
2. Set a tone to the better hearing ear 10 dB above threshold.
3. Set the tone to the poorer hearing ear hearing 10 dB below the indicated threshold.
4. Present both tones simultaneously and wait for the patient to indicate the tone has
been heard.
Result
Patient does not respond The patient is simulating (Positive Stenger).
Patient does respond The patient’s hearing loss in the poor ear is genuine
(Negative Stenger).
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5.7.3.8 SISI (Short Increment Sensitivity Index) Test
NOTE: To use this function you must activate the Extended Special Tests License.
Section 1.4.9 Short Increment Sensitivity Index (SISI) Test
The SISI Test is a reduced and automatic tone test with non-changeable pre-settings:
• Monaural presentation is fixed.
• Tone is fixed as signal type.
• Steady is fixed as tone type.
as a transducer.
SISI Test Screen
Figure 23 shows the SISI Test screen. Table 10 gives explanation.
1
2
4
5
3
Figure 23
Table 10 Explanation of SISI Test Screen
Functions
1 Patient An orange bar lights up if the patient gives feedback with the patient
Response response switch.
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Functions
2 3 4
Figure 24
The information includes
When a stimulus is presented to the patient the small box
1
on the edge of the bar turns green.
Signal type and tone type, displayed in the color of the ear
2
selected (Right ear/Red, Left ear/Blue).
Hearing level, displayed in the color of the ear selected
3
(Right ear/Red, Left ear/Blue).
4 Selected frequency
3 Increment to select a value between 1 dB and 5 dB.
Button
4 Audiogram shows the predetermined threshold as well as the currently
frequency and level selected (+ cursor). Increment presentation is
indicated by a slight shift of the cursor.
5 Result Table Displays single results while testing: Given and recognized
increments and as result the ratio in a percent. The results are set
back whenever the increment is changed or the test stops.
A green frame around the table indicates the patient response
window. The patient response window is the time in which the
patient can give a valid response to a given increment. Only
responses given within the Patient Response Window are recorded
as Recognized.
6 Base Levels show the result for each base level and frequency.
and Results
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How to Perform the SISI Test

NOTE: Determine the hearing loss (HL) and Uncomfortable Loudness Level (UCL)
before starting the SISI Test.
1. Instruct the patient to press the patient response button as soon as an increment
is perceived.
2. Press/use:
to select the ear.
to select a frequency where the hearing threshold is

+/- keys
≥40 dB HL.
Right or left control

to select the level 20 dB SL.
dial
Increment button to select an increment between 2 dB to 5 dB for familiarization.
STIM key or key to start the tone presentation. The presentation of the
increment is indicated in the numerical bar and by a slight shift
of the cursor in the audiogram.
The patient response must be given within 1.5 s in the indicated
patient response window to be counted as recognized.
Increment button to lower the increment to 1 dB for testing.
to store the result, only available after 10 correctly recognized

S key
1 dB increments (Result: 100 %)
 to cancel test if needed. No result will be stored.
Once 1 dB increment is selected the test runs fully automatic. The test stops
automatically after 20 presentations of increments and is saved automatically in the
Base Levels and Results tables.
Repeat the test at another frequency if necessary.
Result
Recognized increments (%) ≥ 60 % Sensorineural disorder
Recognized increments (%) ≤ 15 % Retrocochlear disorder
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5.7.3.9 Tone Decay Test
Section 1.4.10 Tone Decay Test
The Decay Test is a reduced and automatic tone test with non-changeable pre-settings:
• Monaural presentation is fixed.
• Tone is fixed as signal type.
• Steady is fixed as tone type.
as a transducer.
Tone Decay Test Screen

Figure 25 shows the Tone Decay Test screen. Table 11 gives explanation.
1
2
4
3
Figure 25
Table 11 Explanation of Tone Decay Test Screen

Functions
1 Patient An orange bar lights up if the patient gives feedback with the
Response patient response switch.
8521193 Rev. 3 46 27/04/2022

Functions
1
2 3 4
Figure 26
The information includes
When a stimulus is presented to the patient the small box
1
on the edge of the bar turns green.
2
selected (Right ear/Red, Left ear/Blue).
Hearing level, displayed in the color of the ear selected
3
(Right ear/Red, Left ear/Blue).
4 Selected frequency
3 Audiogram shows the predetermined threshold as well as the currently
frequency and level selected (+ cursor).
4 Diagram Displays the decay for pure tones in dB over time. The time period
for how long a level is heard is noted at each level step. The hearing
level that the patient can hear for 60 s is determined.
Presentation of results:
• Vertical dash : The tone is heard for 60 s at the same level.
• Down arrow : Decay > 30 dB or the maximum level has
been reached.
• Numbers : indicate how long the patient presses the
patient response button.
8521193 Rev. 3 47 27/04/2022

How to Perform the Tone Decay Test

before starting the Tone Decay Test.
The level is limited to 100 dB HL to prevent hearing damages.
1. Instruct the patient to press the patient response button as soon as and as long as
the tone is heard and release it if it is not heard anymore.
2. Press/use:
to select the ear.
Right or left control

to select a level. 5 dB SL or 10 dB SL are recommended.
dial
STIM OR key to start presentation of the continuous tone.

The recording starts as soon as the patient presses the patient
response button, and the graph is drawn simultaneously into
the diagram. The level is kept as long as the patient presses
the button.
When the patient response switch is released, the level
increases automatically in 5 dB steps every 5 s, until the patient
presses the button again.
NOTE: The test stops automatically, if the patient does not
press the patient response button after start of presentation.
 to cancel test if needed. No result will be stored.
The test stops and stores automatically

• as soon as the patient presses the patient response button for 60s at the same
level (Pass)
OR
• the level is >100 dB HL or the level increase is >30 dB HL (Refer).
Result
Pass Increase of level ≤ 30 dB Sensorineural disorder
Refer Increase of level > 30 dB Retrocochlear disorder
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5.7.3.10 Alternate Binaural Loudness Balance (ABLB) Test
Section 1.4.11 Alternate Binaural Loudness Balance (ABLB) Test
The ABLB Test is a reduced tone test with non-changeable pre-settings:

• Tone is fixed as signal type in both channels.
• Pulse is fixed as tone type.
as a transducer.
Figure 27 shows the ABLB Test screen. Table 12 gives explanation.
1
2
5
4
3
Figure 27
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Table 12 Explanation of ABLB Test Screen

Functions
2 Numerical Bar The numerical bar shows the numerical data for the testing
operation of the device (Figure 28).
1a 1a 1b
2a 3a 4 3b 2b
Figure 28
1a/ When a stimulus is presented to the patient the small box
1b on the edge of the bar turns green.
2a/ Signal type and tone type, displayed in the color of the ears
4a Frequency for both channels.
3 Stimulus Select Stimulus length between channel switching.
length key
4 Audiogram Shows the hearing thresholds and the levels for each channel at
the selected frequency (+ cursor).
5 Laddergrams Show the level pairs of equal loudness of different frequencies of
the right and left ear separately. The level pairs are connected
with a line.
How to Perform the ABLB Test
before starting the MLB Test.
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Press/use:
to select the ear.
Select 500 ms or 1000 ms.

Stimulus length key NOTE: The stimulus length can be changed during
presentation.
to set a frequency. The frequencies are displayed above the

+/- keys
laddergrams.
to set the level for the right (red) and the left (blue) ear. Set the
start level as follows:
Left/Right Control
Dial • Better frequency: 20 dB SL
• Poorer frequency: 0 dB SL
to start presentation. The small box on the edge alternately

STIM OR key light up green.
S key to store frequencies and levels of both channels.
STIM OR key to stop presentation without storing.
Repeat the procedure for other levels and frequencies.

Increase the level at the poorer frequency in 5 dB steps until loudness is equal for both
frequencies.
Repeat measurement:
Increase the level in 20 dB steps at the better frequency until either the patient’s
discomfort level (UCL), the maximum output of the audiometer or complete loudness
compensation is reached.
Result
Complete loudness compensation: Equal levels are perceived as equally loud.
Loudness compensation Sensorineural disorder
No loudness compensation Retrocochlear disorder
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5.7.3.11 Monaural Loudness Balance (MLB) Test
Section 1.4.12 Monaural Loudness Balance (MLB) Test
The MLB Test is a reduced tone test with non-changeable pre-settings:

• Monaural presentation is fixed. The same ear is selected for both channels.
• Tone is preselected as signal type in both channels.
• Pulse is fixed as tone type.
as a transducer.
Figure 29 shows the MLB Test screen. Table 13 gives explanation.
1
2
5
4
3
Figure 29
Table 13 Explanation of MLB Test Screen
Functions
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Functions
1a 1a 1b
2a
Figure 30 3a 4a 4b 3b 2b
1a/ When a stimulus or noise is presented to the patient the
1b small box on the edge of the bar turns green.
2a/ Signal type and tone type, displayed in the color of the ear
4a/
Frequency of channel.
4b
3 Stimulus Select the stimulus length between channel switching.
length key
4 Audiogram Shows the hearing thresholds and the levels for each channel at
the selected frequency (+ cursor).
5 Laddergrams Show the level pairs of equal loudness of different frequencies of
the right and left ear separately. The level pairs are connected
with a line.
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How to Perform the MLB Test
before starting the MLB Test.
Press/use:
to select the ear.
Select 500 ms or 1000 ms.

Stimulus length key NOTE: The stimulus length can be changed during
presentation.
to set the frequencies. The frequencies are displayed above

+/- keys
the laddergrams.
to set the level of the different frequencies. Start Level:

Left/Right Control
• Better frequency: 20 dB SL (hearing threshold + 20 dB)
Dial
• Poorer frequency: 0 dB SL (hearing threshold)
to start presentation. The small box on the edge alternately

STIM OR key light up green.
S key to store frequencies and levels of both channels.
STIM OR key to stop presentation without storing.
Repeat the procedure for other levels and frequencies.

Increase the level at the poorer frequency in 5 dB steps until loudness is equal for both
frequencies.
Repeat measurement:
Increase the level in 20 dB steps at the better frequency until either the patient’s
discomfort level (UCL), the maximum output of the audiometer or complete loudness
compensation is reached.
Result
Complete loudness compensation: Equal levels are perceived as equally loud.
Loudness compensation Sensorineural disorder
No loudness compensation Retrocochlear disorder
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5.7.3.12 Langenbeck Test
The Langenbeck Test is a reduced tone test with non-changeable pre-settings:

• Monaural presentation is fixed. The same ear is selected for both channels.
• Tone is preselected as signal type in channel 1, Masking Noise in channel 2.
as a transducer.
Figure 31 shows the Langenbeck Test screen. Table 14 gives explanation.
1
2
Figure 31
Table 14 Explanation of Langenbeck Test Screen
Functions
1a 1a 1b
2a 3a 4 3b 2b
Figure 32
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Functions
2a/ selected (Right ear/Red, Left ear/Blue).
2b
Masking noise for masking of the test ear.
4 Frequency for each channel.
3 Audiogram Show the results of the right and the left ear of the Langenbeck
Test (clear) and Tone Audiometry (faded).
4 Masking Table Shows the effective masking values of the Langenbeck test for
each ear.
How to Perform the Langenbeck Test
NOTE: The general testing procedure is similar to the one for threshold determination.
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Masked Threshold Determination

Press/use:
to select the ear for the channel.
Steady/Pulse/Warble/P&W to select the Tone Type corresponding to

+/- keys to set a frequency.
to select a masking noise level corresponding to the
Left Control Dial hearing threshold of the frequency to overlap between 45
dB HL and 75 dB HL.
Left key to present the masking noise constantly.
to select a level. You can use a procedure of “down 10
Right Control Dial
dB, up 5 dB” to determine the threshold.
to present/interrupt the tone signal (depending on whether
key
you have selected Presenter or Interrupter mode).
S key or to store the masked hearing threshold at selected level.
S key (for 2 s) to store a No Response result.
Repeat this procedure for a few normal hearing frequencies and a few impaired
frequencies at the same masking level.
NOTE: The cursor within audiogram:

• + indicates the Signal level.
• - identifies Masking level. It is not possible to store a masking level in the audiogram.
Result
Masked threshold equal to noise level Sensorineural disorder
Masked threshold higher than noise level Retrocochlear disorder
8521193 Rev. 3 57 27/04/2022

5.7.4 Speech Tests
5.7.4.1 General
WARNING Use of unrecognized speech material can lead to faulty results

and therefore wrong diagnosis.
Only recognized speech material can be used (i.e. material
with known relation to the calibration signal).
The MA 42 supports speech audiometry. To conduct speech tests using speech test
material you can use a microphone, external audio with Auxiliary or integrated Wave files.
NOTE: The tests are described in the following sections. For MCL and UCL testing
and masking see:
Section 5.7.6 Masking
5.7.4.2 Speech Audiometry Screen
The Speech Test screen is shown in Figure 33 (Diagram view) and Figure 34 (Table
view). Table 15 gives explanation of what the Speech Test screen displays.
NOTE: For functionality of operating elements see:
1 1
2 2
3 3
4 4
Figure 33 Figure 34
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Table 15 Explanation of Speech Test Screen

Functions
1 Status Bar displays the Date/Time and the status of PC Connection (green
1a 1b
2a 3a 4 3b 2b
Figure 35
Speech input symbol (i.e. microphone, auxillary 1/2, Wave 1/2
2a/ etc.) for test ear/channel.
2b Masking noise symbol for masking of non-test
ear/channel.
WRS Counter: Number of words (absolute number and
4
percentage) that have been recognized correctly.
3 VU meter A VU meter is displayed for the input signal.
The VU meter allows you to monitor if the input signal for optimal
sound quality. 0 is the optimal level when the signal is presented.
Input calibration for the microphone and Auxiliary can be adjusted
by pressing the right STIM/Monitor key. See also:
Functionality of Operating Elements –

Section 5.4
Table 8
4 Result Results are stored on the device for review. The display can be
Display configured to Diagram or Table within the settings.
Section 5.9.4 Speech Settings
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5.7.4.3 Speech Audiometry with Microphone or External Audio Device (AUX)

If you are using an external audio device powered by electrical
WARNING current, the player must meet electrical safety requirements,
such as IEC 62368-1, IEC 60601-1 or UL 60601-1. This is to
avoid electrical shock of either the patient or you. If you are not
sure if your player meets these requirements it is safer to use
battery power.
Section 2.6 Electrical and Electrostatic Safety
Preparation
NOTE: and / requires stimulus to be activated with STIM/Monitor or STIM/Talk

key to start presenting.
Make sure the input calibration is correct. Input calibration of and / can be
completed by STIM/Monitor key.
Microphone:
Only for use of external microphone

Connect headset to device.
(configuration dependent):
Select External Microphone in the settings if you want to use the headset microphone
or Internal if you want to use the built-in microphone.
Section 5.9.2.1 Basic Settings – General – Microphone
Test Setup – Advanced Select to select microphone as input signal.
External Audio Device:
Connect the external audio device to the MA 42.
to select auxiliary 1 as input signal.

Test Setup – AUX 1 refers to the left channel of a stereo input signal.
Advanced Select to select auxiliary 2 as input signal.
AUX 2 refers to the right channel of a stereo input signal.
NOTE: The auxiliary input is limited to 1-channel operation. It is not possible to select
AUX 1 and AUX 2 simultaneously.
NOTE: For more information on connecting components and on input calibration see:
Section 4.2.2 Rear Panel Connections
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5.7.4.4 Speech Audiometry with Wave Files
NOTE: If you use a Wave test the first time, you may need to import the test and/or
select default test in the settings.
Section 5.9.4.3 Speech Settings – Wave
NOTE: Pre-calibration of the Wave lists was implemented into the recording and
installation of the Wave files on the MA 42. No input calibration is required.
The test type is predefined based on the selected Wave file.
to select Wave channel 1 as input signal.
Test Setup – WAV 1 refers to the left channel of a stereo input signal.
Advanced Select to select Wave channel 2 as input signal.
WAV 2 refers to the right channel of a stereo input signal.
Figure 36
NOTE: Once the Wave Playback is started, it is not possible to change the WRS test
parameters anymore. For the SRT test, only the level can be changed. This is indicated
by the deactivation of several keys. To change the settings, store or cancel the test.
8521193 Rev. 3 61 27/04/2022

Press:
to open the Speech Test List (Figure 37).
Figure 37
Control Dial to select the speech test.
to enter the speech test selection and open the Group List.
key
OR
Cancel
Figure 38
to close the Speech Test List and return to Speech Test
(Figure 38).
Control Dial to select the group from list.
key to enter the selection of a group. After selection you

OR automatically enter the test screen.
Back to close the Group List and return to Speech Test List.
Test Setup key to change test type if needed (e. g. WRS).

NOTE: Test type is predefined by selected test group.
to select the test ear(s) for the channel(s).
to select the Speech Signal Input for patient’s ear to be tested

and Masking signal for the other ear if needed.
Left and Right to set the level.

Control Dial
8521193 Rev. 3 62 27/04/2022

key to present speech material.
MCL and UCL testing: to pause and continue/play long

/ key running Wave files
SRT test: to select the next word.
+ key
WRS test: to enter a correct answer.
SRT test: to select the previous word.
- key
WRS test: to enter a wrong answer.
WRS test: You can see the ratio of the number of correctly
recognized words and presented words in the Numerical Bar
(absolute and percentage).
S key to store the result.
to cancel test. No result will be stored.
The next test group is automatically selected to continue with testing. Proceed as
described above for the next hearing level or test type.
NOTE: If only one speech test is available the Speech Test List is skipped, and the Group
List is displayed directly. Select Cancel to return directly to the Speech Test screen.
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5.7.4.5 Speech Recognition Threshold (SRT or SRT )
Section 1.4.16.6 Speech Recognition Threshold (SRT)
Familiarization
For the SRT test familiarize the patient with a closed set of spondaic words at a level loud
enough for them to hear and understand. Begin the test and decrease the level as the
patient repeats the word.
Press:
Test Setup key to select test type SRT or SRT .
NOTE: If Speaker is selected, SRT is automatically preselected.
to select the Speech Signal Input for patient’s ear to be tested and
Masking signal for the other ear if needed.

Control Dial
key or STIM to present speech material according to speech input signal.
S key (briefly) or to store a positive result.
S key (for 2 s) to store a no response result.
Continue decreasing the level as the patient repeats the word. Once the threshold has
been found press the S key button to save the result.
NOTE: If you store a new threshold value, the old value is overwritten.
8521193 Rev. 3 64 27/04/2022

5.7.4.6 Word Recognition Score (WRS or WRS )
Section 1.4.16.7 Word Recognition Score (WRS)
The Word Recognition Score (WRS) is calculated separately for each hearing level. Up
to 100 words can be tested.
Proceed as follows for each hearing level.
Test Setup key to select test type WRS or WRS .
to select the Speech Signal Input for patient’s ear to be tested

and Masking signal for the other ear if needed.

Control Dial
key or STIM to present speech material according to speech input signal.
+ key to count a word as heard.
- key to count a word as not heard.

You can see the ratio of the number of correctly recognized
words and presented words in the Numerical Bar (absolute
and percentage).
S key to store the result.
Proceed as described above for the next hearing level.
NOTE: Once the WRS test is started and the counter is running, it is not possible to
change test parameters. This is indicated by the disabling of several buttons. To change
the settings, store or cancel the test.
8521193 Rev. 3 65 27/04/2022

5.7.4.7 Freiburger Speech Test
NOTE: Determine the hearing loss using the Tone Test before starting the Freiburger
Speech Test.
Section 1.4.14 Freiburger Speech Test
Section 5.7.1 Test Selection
NOTE: Pre-calibration of the Freiburger Speech test lists was implemented into the
recording and installation of the Wave files on the MA 42. No input calibration is required.
You have the following Test Type options to perform the Freiburger Speech Test:
1. Numbers: to determine the level for 50 % Comprehensibility to find the Hearing
Loss for Speech. The test includes 10 groups of 10 polysyllables number words
each. A person with normal hearing can correctly repeat half of the number at 18.5
dB.
2. Words: to test the volume for maximum comprehensibility (100%) of monosyllabic
words without reaching the discomfort threshold. The test includes 20 word groups
with 20 monosyllabic words.
3. MCL/UCL: to determine of Most Comfortable Level (MCL) or Uncomfortable Level
(UCL).
Freiburger Speech Test Screen

The Freiburger Speech Test screen (Figure 39) shows a diagram. On the horizontal axis you
will find the Speech level (in dB). On the vertical axis you will find the Comprehensibility (in %)
on the left side and the Discrimination Loss (in %) on the right side. Furthermore, the
reference values for the tests with monosyllables and polysyllables are drawn in the diagram.
The values for the left and right ear are combined in the same diagram. The values can
be distinguished by color (Red = Right, Left = Blue) and symbols. Symbols of the test
type Numbers are labeled with a Z, symbols of the test type Words with a W.
8521193 Rev. 3 66 27/04/2022

1
2
3
7 6
5
6
Figure 39

Functions
1 Status Bar displays the Date/Time and the status of PC-connection (green
1a 1b
2a 3a 4 3b 2b
Figure 40
2a/ Speech input symbol Wave 1 for test ear/channel.
2b Noise symbol for masking of non-test ear/channel.
4 Ratio of correctly recognized words (total and percentage).
3 VU meter A VU meter is displayed each for the input signal and for masking.
The VU meter allows you to monitor if the input signal for optimal
sound quality. 0 is the optimal level when the signal is presented.
8521193 Rev. 3 67 27/04/2022

Functions
4 Word group Word group and words presented. The previous word presented is
color-marked (green = correct, red = wrong).
5 Diagram Results are stored on the device for later printing or saving as PDF
file to USB flash drive.
6 Test type Selection of Test type (predefined based on Wave file selected).
7 Cancel. No result will be stored.
8 MCL and UCL testing: to pause and continue/play long running

/ key Wave files
NOTE: Once the Wave Playback is started and the counter is running, it is not possible
to change test parameters. This is indicated by the disabling of several buttons. To
change the settings, store or cancel the test.
How to Perform the Freiburger Speech Test with Numbers or Numbers
Press/use:
to select WAV1 for patient’s ear to be tested and Masking

signal for the other ear if needed.
to open the menu for group selection (Figure 41).
Figure 41
Control Dial to select a group of numbers.
8521193 Rev. 3 68 27/04/2022

to enter the selection of a group of numbers. After selection

key
you automatically enter the test screen.
to select a level for Wave file presentation and Masking Noise

Control Dial (for monaural presentation). Start the test with a level 20 dB
above the hearing loss at 500 Hz and 1 kHz.
to select a number within the group if you do not want to start

+/- keys
from the beginning.
to start the presentation of the numbers. The green indicator
key or STIM and STIM lights up during the presentation.
to store a correct (+) or a wrong (-) answer. Proceed until all

+/- keys
single results have been stored OR press:
to finish the test without having the whole speech material

S key
presented (stored values are saved).
The next test group is automatically selected to continue with testing.
Evaluation
If the measured value is between 30 and 70 % of comprehensibility, a parallel to the
normal curve is automatically drawn at the end of the test. The intersection with the
standardized hearing loss scale for numbers at 50 % understood results in the hearing
loss for numbers (HVZ = Hörverlust für Zahlen). In addition, the HVZ result is displayed
above the diagram.
If the first test already results in more than 70 % or less than 30 % comprehensibility, the
level is to be reduced or raised by 5 dB and the test must be repeated with another set of
numbers. The goal is to find the level for 50% comprehensibility to determine the hearing
loss for speech.
If two measurement points are stored above and below the 50%, the second
measurement point found is connected to the first measurement point and you now get
an intersection with the hearing loss scale.
NOTE: Only in the device the HVZ result is additionally shown above the diagram. In the
printouts or the PC software MAICO Sessions, the result is displayed in the diagram and
in an additional results table.
8521193 Rev. 3 69 27/04/2022

How to Perform the Freiburger Speech Test with Words or Words

Press/use:
to select WAV1 for patient’s ear to be tested and Masking

signal for the other ear if needed.
to open the menu for group selection.
Control Dial to select a group of words.
to enter the selection of a group of words. After selection you

key
automatically enter the test screen.
to select a level for Wave file presentation and Masking Noise

Control Dial
(for monaural presentation). Start the test with a level 65 dB.
to start the presentation of the word group. The VU meter

STIM
strikes out during the presentation.
to store a correct (+) or a wrong (-) answer. Proceed until all

+/- keys
single results have been stored OR press:
to save the result. You can also save the result without having
S key presented the whole word group.
The comprehensibility achieved at a given level is documented in the diagram. If the

patient has not recognized 100 % of the words of a word group, start a new test round.
To do this, increase the level by 15 dB. The next test group is automatically selected to
continue with testing.
Evaluation
For normal hearing patients, record the value at which 100 % of the words were
perceived.
If this is not possible due to the subject's hearing impairment, the slope of the intelligibility
curve for increasing levels is recorded until the maximum intelligibility is found.
NOTE: In the device, the result of comprehensibility is only drawn in the diagram. In the
printouts or the PC software MAICO Sessions, the result is displayed in the diagram and
in an additional results table.
8521193 Rev. 3 70 27/04/2022

5.7.4.8 QuickSINTM Test
Section 1.4.15 QuickSINTM Test
NOTE:
• Pre-calibration of the QuickSINTM lists was implemented into the recording and
installation of the Wave files on the MA 42. No input calibration is required.
• Default screen set-up of QuickSINTM test screen is binaural presentation at 70
dB based. For monoaural testing, the L & T Function must be set to Unlock.
• Review the QuickSINTM manual for complete instructions
NOTE: Once the Wave Playback is started and the counter is running, it is not possible
to change test parameters. This is indicated by the disabling of several buttons. To
change the settings, store or cancel the test.
1
2
3
4
5 6
Figure 42

Functions
1 Status Bar displays the Date/Time and the status of PC-connection (green
if connected to MAICO Sessions).
1a 1b
2a 3a 3b 2b
Figure 43
8521193 Rev. 3 71 27/04/2022

Functions
1a/ When a stimulus is presented to the patient the small
1b box on the edge of the bar turns green.
2a/2b Stimulus symbol (i.e. wave file) per channel.
Hearing level displayed in the color of the ear being
3a/3b
tested (Right ear/Red, Left ear/Blue).
3 VU meter The VU meter allows you to monitor the input signal being
presented.
4 List Word group selected
5 Sentences Sentences of the word group selected.
6 SNR table Shows how many words per sentence were correctly recognized at
the respective SNR.
7 Table Results are stored on the device for review.
8 Cancel. No result will be stored.
How to Perform the QuickSINTM Test

NOTE: For more detailed information on QuickSINTM test see:
QuickSINTM Speech-in-Noise Test instructions by Etymotic Research, Inc.
Select the QuickSINTM test from the Special Test menu. The
test screen opens, and the available lists are presented in a
menu for selection (Figure 44).
Figure 44
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Press/use:
to open the menu to change Wave file selection.
Control Dial to select list for QuickSINTM list for playback.
to make selection from QuickSINTM menu. After selection you

key
automatically enter the test screen.
to change the channels for WAV1 or WAV2.
key or
to start the presentation of the Wave file.
STIM
to store a correct (+) or a wrong (-) answer for the words written
in capital letters. The answers will be highlighted in green
(correct) and red (incorrect) once scored.
+/- keys Proceed until all single results have been stored. As soon as
you have stored all values for a sentence, presentation of the
next sentence starts automatically.
Proceed until all answers for all sentences have been stored.
To cancel test, no results will be stored.
The next word list is automatically selected to continue with

testing.
Evaluation
The SNR Loss is automatically calculated at the end of the test and plotted in the table.
For greater accuracy, two or more lists should be averaged to report the SNR Loss. To
interpret the SNR Loss score, see Table 16.
Table 16 Interpretation of SNR Loss Score
SNR Loss Degree of SNR Loss Expected Improvement with directional Mic
0 dB - 3 dB Normal/near normal May hear better than normal hear in noise
3 dB to 7 dB Mild SNR loss May hear almost as well as normal hear in noise
7 dB - 15 dB Moderate SNR loss Directional microphones help. Consider array mic.
> 15 dB Severe SNR loss Maximum SNR improvement is needed.

Consider Frequency Modulation (FM) system.
8521193 Rev. 3 73 27/04/2022

5.7.4.9 Speech Stenger
Section 1.4.7 Stenger Test (Pure Tone and Speech)
The Speech Stenger is a reduced speech test with non-changeable pre-settings:

• Lock is fixed – levels for right and left ear change simultaneously
as a transducer.
The Speech Stenger screen shows the current test results of Speech Audiometry (Figure 45).
Figure 45
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How to Perform a Speech Stenger

Press/use:
to select the Speech Input Signal for patient’s ear to be tested.
1. Instruct the patient to repeat the word when the speech signal is heard.
2. For the ear with the better hearing ability: Set the level of the speech signal 10 dB
above speech recognition threshold.
3. For the ear with the poorer hearing ability: Set the level of the speech signal 10 dB
below the indicated threshold.
4. Present simultaneously and wait for the patient to repeat the word.
Result
Patient does not repeat the word The patient is simulating (Positive Stenger).
Patient does repeat the word The patient’s hearing loss in the poor ear is genuine
(Negative Stenger).
5.7.4.10 Master Hearing Aid (MHA)
Section 1.4.8 Master Hearing Aid (MHA)
Section 5.7.4.4 Speech Audiometry with Wave Files
The MHA is a reduced speech test with non-changeable pre-settings:

as a transducer.
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Press/use:
to select the Speech Signal Input for patient’s ear to be tested.
to lock the presentation of the signals in both channels and

L & T Function automatically increase and decrease channel 1 and 2 levels
with the rotation of only one Control Dial (either side).
Select filter according to the hearing loss: the more severe the
Filter Selection
high-frequency loss, the steeper the filter.
Control Dial to adjust the level to compensate for hearing loss.
key With Microphone and AUX: to present a Word.
+/- keys With Wave: to set a word AND
key to present the word.
to cancel test.
Result
This function gives a sense of the benefits of a hearing aid and what could eventually be
gained by getting properly fitted hearing aids
5.7.5 Test Types for Tone Test and Speech Test
5.7.5.1 Most Comfortable Level (MCL)
Press:
Test Setup key to select test type MCL.
Left and Right Control Dial to set the level to most comfortable level.
key or STIM to present speech material.
With Wave: to pause and continue/play long

/ key running Wave files
S key to store the result for the most comfortable level.
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5.7.5.2 Uncomfortable Level (UCL)
Using too high a sound pressure level can lead to hearing loss
in the patient.
WARNING
Start the test at a comfortable level and slowly increase it with
continuous feedback from the patient.
Press:
Test Setup key To select test type UCL.
Left and Right Control Dial to set the level to uncomfortable level.
key or STIM to present speech material.
/ key With Wave: to pause and continue/play long

running Wave files.
S key to store the result for the uncomfortable level.
5.7.6 Masking
Section 1.1.1
To ensure that the patient will not experience crossover mask the opposite ear. Masking
may increase the hearing threshold of the test ear.
For bone conduction the masking signal is automatically routed to the opposite output of
the head- or insert phone, based on the test ear selected.
Noise Types
The following noise types can be used for masking:
Tone: Narrow band noise, and White noise
Speech: Speech noise and White noise
NOTE: Noise type is defined in the settings:
Section 5.9.3.1 Tone Settings – General
Section 5.9.4 Speech Settings – General
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Manual Masking
NOTE: Be cautious to set the noise to an appropriate level before starting to test.
Test Setup keys
to assign Signal/Masking Noise to the left and right ear.
and/or
Left and Right

to increase or decrease level.
Control Dial
Left or Right STIM to present the masking noise (press left or right STIM key
key according to the assignment you made before).
to present/interrupt the tone signal (depending on whether you

key
have selected Presenter or Interrupter mode in the settings).
to store the hearing threshold. The value is stored with the

S key
corresponding masking symbol.
Proceed accordingly for the other frequencies. Adjust the masking signal each time you
change the level of the test signal.
Automatic Masking
If you do not want to adjust the masking signal manually, you can use the Track function
of your device.
Test Setup keys
to assign Signal/Noise to the left and right ear.
and/or
8521193 Rev. 3 78 27/04/2022

Left and Right

to increase or decrease level.
Control Dial
Track function to set the difference between tone and masking signal. This
key difference is maintained during level changes.
Left or Right to present the masking noise (press left or right STIM key
STIM key according to the assignment you made before).
to present/interrupt the tone signal (depending on whether you
key have selected Presenter or Interrupter mode in the settings).
to store the hearing threshold. The value is stored with the
S key corresponding masking symbol.
Proceed accordingly for the other frequencies. Adjust the masking signal each time you
change the level of the test signal.
NOTE: Track is always set back automatically when the test setup up is changed.
5.7.7 High Level Warning

A visual warning in the numerical bar is displayed at high volumes (i.e. 100 dB or more).
Visual warnings include:
Numerical bar turns yellow and a warning icon is displayed in numerical bar when a
level is 100 dB HL or greater (Figure 46).
Figure 46
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5.7.8 Symbols
The icons displayed in the tests can be selected in the Settings Menu.
Section 5.9.2.1 Basic Settings – General
An overview over the different symbol sets is given in Table 17:

Table 17 Symbol Sets
Test
Standard Japan UK Australia Hong Kong
Type
R L R L R L R L R L
AC HL X X X X X
AC
HL X
(masked)
BC HL < > < > < > < >
BC
HL
(masked)
Sound-
field
HL S S B B
Aided Aided A A ◢ H V
MCL MCL M M M M M M M M M M
UCL UCL U U ˄ ˅ U U
NR UCL
5.8 Managing Test Results

5.8.1 General
Dependent on the configuration there are different possibilities to manage test results. It
is possible to
• delete test results,
• store the test results as a PDF file on a USB flash drive.print the session directly
to the thermal printer HM-E300 (optional accessory)
• transfer result to MAICO Session software (optional)
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5.8.2 Deleting Test Results

Delete stored test data as follows:
• Delete whole session and start a new session by using the key.
• Delete single stored values by using the key.
NOTE: To delete entire tests, all single stored values of the test must be deleted.
For a detailed description see:
5.8.3 Store Test Results as PDF File

Test results can be stored as a PDF file on a USB flash drive to be later transferred to a
PC for further usage. Make sure a USB flash drive connected to the USB socket on the
rear side of the device.
Print by using the key.

The data shown on the report can be adjusted in the settings.
Section 4.2.2 Rear Panel Connections
Section 5.9.2.5 Basic Settings – Report
5.8.4 Printing Test Results with the Thermal Printer

All stored results can be directly printed via the thermal printer. Make sure the printer is
turned on and connected.
Print by using the key.
Section 4.5 Using the Printer
NOTE: The quick select option or can be selected in settings.
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5.8.5 Understanding the Report

The print-out displays the following information (Figure 47):
1 MAICO logo and name of device

1
2 Facility logo: if imported in the Settings.
2 3 Facility: provides facility information, if entered in
the Settings.
4 Patient data: provides the field names Patient
3 ID, Last name, First name, Date of birth and
Gender, to manually enter.
4 5 Examiner: empty line for examiner‘s signature.
6 Session date and time: shows the date and time of

5 the session as defined in the device.
6
7 Test result: graphical display for Tone test (7a)
and Speech test results (7b).
7
8 Masking table: prints masking table defined in
the settings for Display type.
7a
9 Footer: prints legend explaining the symbols as
well as last calibration date and serial number, if
activated in the Settings.
NOTE: PDF and Printout show the same

information.
8
7b
9
Figure 47
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5.9 Settings
5.9.1 General
Navigation
To navigate in the Settings Menu press/use:
Advanced
OR to open the advanced selection menu.
Select
to open the Settings Menu (Figure 48).
Figure 48
Control
to select a sub-setting.
dial
key to enter the selected sub-setting.
to enter a sub-setting tab (Figure 49).
Tab key
Figure 49
to go back to the previous screen.
to go back to the Tone/Speech Test screen.
NOTE: The changed settings are automatically saved upon activation.
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Changing a setting
To change a setting proceed as follows:
Option to select only one item. Press/use:

button
Right/left to select the wanted option.
Control Dial
key to activate the wanted option.
Check box to select or deselect several items at the same time. Press/use.
Right/left to select the option that you want to activate or

Control Dial deactivate.
key to select/deselect the option.
Bar to select a value displayed in the bar.

selection
Right/left to select the menu item (highlighted light blue,
Control Dial Figure 50).
Figure 50
key to activate the option (bar highlighted green,

Figure 51).
Figure 51
Right/left to select a value.
Control Dial
key to set a value.
Data entry to make data entries.
Right/left to select the menu item (highlighted light blue,

Control Dial Figure 52).
Figure 52
key to open the Built-In keyboard. See below.
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Using the Built-In Keyboard
Key The keyboard (Figure 53) opens automatically if you select a line
by using the key.
Figure 53
Use the:
Left control dial to navigate left/right.
Right control dial to navigate up/down.
key to select a key.
The keyboard offers letters, numbers, punctuation marks, and other special characters.
Some of them are important for navigation and therefore are explained below:
to switch between 2 keyboards (upper/lower case and different special

characters).
to delete the last character.
to go to the last/next character.
to go to the last/next data entry field.
to close the keyboard.
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5.9.2 Basic Settings
5.9.2.1 Basic Settings – General
Display:
Defines the default ear side/channel assignment. (Figure
54).
Figure 54
Default test screen:

Defines which test screen is shown when starting the device
Figure 55 and assigns the quick select test screen (Figure 55).
Default transducer:
Defines which transducer is selected at device startup
Figure 56 (Figure 56). The transducer can be changed during testing
by using the transducer selection keys.
NOTE: Disabled if only one AC transducer is available or Bone
Transducer with Contra Headset is calibrated to the device.
Masking after store:

Defines how noise is presented after storing (Figure 57).
Figure 57
Select:
Turn off to stop noise after the value has been stored.
Remain to keep noise active after the value has been

stored.
Microphone:
Select Internal (built-in microphone) or External (external
Figure 58 microphone, configuration dependent) for Talk Forward
function and Speech Input.
Symbol set:
Select country specific symbols to be plotted on the
audiogram displays. Choose between: Standard (IEC,
ANSI), Japan, UK, Australia and Hong Kong (Figure 59).
Figure 59
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5.9.2.2 Basic Settings – Level

Increase Level:
Changes the direction of rotation of the control dial on the
increase or decrease of the level (Figure 60). Select:
Figure 60
Dial up to increase the level by turning the control
dial away from the user (and vice versa).
Dial down to increase the level by turning the control
dial towards the user (and vice versa).
Level steps:
Select the change of level when rotating the dial (Figure 61).
Figure 61
Communication:
Activate or deactivate the following microphones and/or
make individual settings regarding the respective volume
(Figure 62):
Talk forward to set the Talk forward default level. Talk

forward allows the examiner to
Figure 62
communicate with the patient through the
patient’s headphones.
Talk back to enable and set the default level of the
optional talk back function. This allows the
patient to communicate with the examiner
through the examiner’s headphones.
NOTE: The volume dial on the examiner headsets must also
be controlled for optimal volume.
5.9.2.3 Basic Settings – Display

Brightness:
Adjust the brightness to your needs (Figure 63).
Figure 63
Language:
Choose one of the supported languages incorporated in the
device (Figure 64).
Figure 64
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5.9.2.4 Basic Settings – Date / Time
NOTE: The following settings define the display of date and time in the status bar and on
the printout.
Set time:
Set the time. If time format 12 h is selected a further setting
is available for selection of AM/PM (Figure 65).
Figure 65
Time format:
Select the preferred time format (Figure 66).
Figure 66
Set date:
Set the current date (Figure 67).
Figure 67
Date format:
Select the preferred date format (Figure 68).
Figure 68
5.9.2.5 Basic Settings – Report
Facility information:
Allows entry of facility information on the printout (i.e. PDF
or thermal printout). Empty fields are not printed.
Figure 69 Use the built-in keyboard (Figure 69).
Section 5.9.1 General
Miscellaneous information:
Select/deselect to show certain information on the report or
Figure 70
not (Figure 70).
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Quick Select:
Select report option for quick select (Figure 71).
Figure 71
PDF format:
Defines the format of the PDF file to be saved on a USB
Figure 72
flash drive (Figure 72).
Facility logo:
A facility logo can be imported to show on the printout/PDF
(Figure 73).
Figure 73
NOTE: The image size will be adjusted automatically for
PDF. For thermal printout, the following size is
recommended: Width: 560, Height: 144. Allowed file name
and format: FCI.bmp.
Press:
Import to import a logo from a connected USB flash

drive.
Delete to delete an imported logo.
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5.9.3 Tone Settings
5.9.3.1 Tone Settings – General
Tone type:
Select a tone type as the default tone. The tone type can
still be switched using the test setup selection keys in the
test screen (Figure 74).
Figure 74
Pulse length:
Select the length of a single pulse (Figure 75).
Figure 75
Masking noise type:

Select the noise type (Figure 76).
Figure 76 NOTE: The Narrow band noise is permanently applied in
the Langenbeck Test.
Signal setup:
Select if the default signal for the Left ear and the Right ear
shall be Tone or Masking. The signal can be changed in
Figure 77 the test screen by using the keys (Figure 77).
Tone STIM mode:

Select a default operation mode (Figure 78). Select:
Figure 78 Presenter to present the signal by touching the key.
Interrupter to interrupt a continuously presented signal

by touching the key.
NOTE: The operation mode can be changed in the test

screen by pressing the STIM key.
Present duration:
The length of the signal with one touch of the key
Figure 79 (Presenter mode only) (Figure 79).
Select a value between 200 ms and 3000 ms or Unlimited
(presents only when button is touched).
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5.9.3.2 Tone Settings – Display
Display type:
Select the way you want the results to be displayed on the
test screen and on the printout (Figure 80). Select:
Figure 80
One audiogram to display one audiogram.
Two audiograms to display two audiograms.
Masking table on to display a table with the effective

masking levels to non-test ear below
the audiogram(s).
BC lines:
Select the line type for the BC results in the audiogram
(Figure 81).
Figure 81
5.9.3.3 Tone Settings – Level

Set default level:
Set the default levels for Tone and Masking (Figure 82).
Figure 82
Default Level:
Set default level after changing test parameters (Figure 83):
Figure 83 On to automatically return to default level set after
changing test parameters.
Off to stay at the same level after ear, transducer or signal

type has changed.
Level change after store:

Control the change of the level after Store/No Response is
Figure 84 executed (Figure 84). Select:
Default level to go to default level.
-30 dB to +20 dB to go to the value set.
Remain to remain at the current level.
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5.9.3.4 Tone Settings – Frequency
Default Frequency:
Select (Figure 85):
Figure 85
On to set 1000 Hz as the default frequency after ear,
transducer or signal type has changed.
Off to stay at the last frequency used after ear,

transducer or signal type has changed.
Frequency control:
Control the movement of the test frequency when selecting
Figure 86
the +/- keys (Figure 86). Select:
Wrap to move to the lowest frequency when the

highest frequency is reached and vice versa.
Back to return to 1000 Hz when the minimum and

maximum has been reached.
Store control:
Control the movement of the test frequency when pressing
the S key for storing a result (Figure 87). Select:
Figure 87
Remain to remain at the same frequency.
Wrap to move to the lowest frequency when the

highest frequency is reached and vice versa.
Back to return to 1000 Hz when the minimum and

maximum has been reached.
Test frequencies:
Select/deselect frequencies that are active for AC and BC
measurements. The device only cycles through active
frequencies in the test screen (Figure 88).
NOTE: 1000 Hz and high frequencies are not available for
deselection and, therefore, excluded from the list.
Figure 88
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5.9.3.5 Tone Settings – PTA
Custom PTA:
Select/deselect frequencies for the calculation of the PTA
value for the default transducer. You can select
8 frequencies each for AC and BC (Figure 89).
NOTE: It is possible to select the same frequency several
times and thus change the weighting.
Figure 89
PTA calculation:
Select (Figure 90):
Figure 90
Standard to display the PTA without decimal place.
Extended to display the PTA with one decimal place.
5.9.4 Speech Settings
5.9.4.1 Speech Settings – General
Display type:
Select the way you want the results to be displayed on the
Figure 91
test screen and on the printout (Figure 91). Select:
Table to display test results in table view.
Diagram to display test results in diagram view.
Test type:
Select which test type should be set by default (Figure 92).
Figure 92 NOTE: The test type can be changed in the test screen by
using the Test Setup keys.
Functionality of Operating
Section 5.4
Elements – Table 3
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Masking noise type:

Select the noise type for masking (Figure 93).
Figure 93
Signal setup:
Select the default Speech Input for each ear (Figure 94).
NOTE: The Signal Setup can be changed in the test screen

• by using the ear selection keys (Quick Select
Figure 94
function).
• by selecting another Speech Input using the test
setup keys for each channel.
Functionality of Operating
Section 5.4
Elements – Table 3
Wave 1 and Wave 2 selection is only enabled if Wave files

have been imported.
Speech test:
Select the test you want to automatically start when entering
Figure 95 the Speech screen (Figure 95): Speech Audiometry or
Freiburger Speech Test.
NOTE: This selection can only be made if Wave files for
Freiburger Speech Test are installed.
Selection of the other test method can still be made via the
Special Test Menu.
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5.9.4.2 Speech Settings – Level
Level unit:
Choose if you want the level unit to be displayed in dB HL
Figure 96
or dB SPL (Figure 96).
Set default level:

Set the default levels for Speech and Masking (Figure 97).
Activate Add PTA to speech default level to increase the
speech default level by the value of the PTA.
Figure 97
Default level:
Set default level after changing test parameters (Figure 98):
Figure 98
On to automatically return to default level set
after changing test parameters.
Off to stay at the same level after changing test

parameters.
Speech filter:
Set the speech filter that shall be applied to the speech
Figure 99
signal (Figure 99). Select:
Auto-linear to linearize the frequency response of the

headphone standard filter.
NOTE: The Auto-linear filter is permanently
applied in the QuickSINTM Test.
Free-field to compensate for free-field conditions. Use

equivalent the filter to make measurements with
headphones comparable to sound field
measurements.
NOTE: If Free-field equivalent is selected,
an asterisk * is displayed in the Numerical
Bar next to the level unit. This filter is
permanently applied for the Freiburger
Speech Test.
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5.9.4.3 Speech Settings – Wave
Manage tests:
to manage Wave files on the device (Figure 100). Press:
Figure 100 Import to import Wave test files from a USB flash
drive. Make sure the USB flash drive is
properly connected to the back of the device.
NOTE: You can use the Speech Extraction
Tool to create your own Wave files. Contact
Technical Customer Support for more
information.
Delete all to delete all Wave test files saved on the

device.
Default test:
NOTE: Only enabled if Wave files have been imported.
Select the default test for Speech, when used as

speech input (Figure 101). The speech test starts
automatically with the selected test. If no default test is
Figure 101 selected, the Speech Test List is displayed upon entry
Speech with .
To select a Speech test list as default press/use:
Select to open the Speech Test List selection

window.
Control
to select a speech test list.
Dial
key to enter the selection of a speech test list. A

new selection window open to select a
specific test list within the Group List.
Proceed as before for selection.
To reset press:
Reset to clear the selection of a default test.
NOTE: If only one speech test is available the Speech

Test List is skipped, and the Group List is displayed
directly.
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5.9.5 Device Information
5.9.5.1 Device Information – General
The screen provides you with all necessary device information (Figure 102).
Figure 102
5.9.5.2 Device Information – Transducers
The screen provides you with all necessary information on the calibrated transducers
(Figure 103).
Figure 103
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5.9.5.3 Device Information – Support
The screen provides contact information for your MAICO representative. The address
must be entered by a service technician (Figure 104).
Figure 104
5.9.5.4 Device Information – Legal
The screen shows the Qt License Agreement (Figure 105).
Figure 105
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5.9.6 License Management

Activation:
To activate a new license enter a license code (Figure 106)
Figure 106 press/use:
Control dial to select the License code data entry field.
key to edit the field. A keyboard opens in the

device for input.
to close the keyboard.
If you entered a correct code a message box tells you

“Licensing completed”.
If the code entered is invalid a message box is shown to verify
the code. Press the key to close the message box.
General – Using the Built-In Keyboard

Section 5.9.1
Licenses:
Shows all available licenses (Figure 107). The checkboxes are
Figure 107
activated automatically as soon as a license is activated.
5.9.7 Service
5.9.7.1 Service – General
Calibration reminder:
Annual calibration of the device and its transducers is
Figure 108
recommended.
Select or deselect this item to enable or disable a reminder that
will display daily. The reminder starts 1 month prior to the
expiration of the calibration date for your acoustic transducer(s)
(Figure 108).
The user can always bypass the reminder message and
continue with screening.
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Manage Settings:
This menu offers different options for organizing your settings
(Figure 109).
NOTE: It is necessary to attach a USB drive before using this
Figure 109
function. Detection of the USB flash drive can take up to 10 s.
Select and press:
Reset to to set all settings back to the factory settings.

factory
Import to import settings from USB flash drive. The

settings are applied immediately.
Export to export settings to USB flash drive.
Error log:
If an error is occurring you can export the error log data to a
Figure 110 USB flash drive (Figure 110).
NOTE: It is necessary to attach a USB drive before using this
function. Detection of the USB flash drive can take up to 10 s.
Press:
Export to export error log data to USB flash drive.
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Technical Data
This section offers you important information about
▪ the MA 42 hardware specifications
▪ connections
▪ the pin assignment
▪ calibration values
▪ electromagnetic compatibility (EMC)
▪ electrical safety, EMC and associated Standards
6.1 MA 42 Hardware
The MA 42 audiometer is an active, diagnostic medical
product according to the class IIa of the Medical
Device Regulation (EU) 2017/745.
General Information About Specifications

The performance and specifications of the device can only be guaranteed if it is
subject to technical maintenance at least once every 12 months.
MAICO Diagnostics puts diagrams and service manuals at the disposal of authorized
service companies.
STANDARDS
Safety Standards IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 +
CORR. 2:2007 + A1:2012 (or IEC 60601-1: 2012 reprint)
ANSI/AAMI ES60601-1:2015+A2::2010+A1:2012
CAN/CSA-C22.2 No. 60601-1:14
EMC Standards IEC 60601-1-2:2014
Audiometer Standards IEC 60645-1:2017 Type 2-EHFclass A-E
ANSI/ASA S3.6-2018 Type 2HF class A
Calibration ISO 389-1:2017 (Reference equivalent threshold sound
pressure levels for pure tones and supra-aural earphones)
ISO 389-2:2017 (Reference equivalent threshold sound
pressure levels for pure tones and insert earphones)
ISO 389-3:2017 (Reference equivalent threshold sound
pressure levels for pure tones and bone vibrators)
ISO 389-4:2017 (Reference levens for narrow-band
masking noise)
ISO 389-4:2005 (Reference threshold of hearing under free-
field and diffuse-field listening conditions)
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DEVICE SPECIFICATIONS
Power supply Consumption Approximately 24 W
UES24LCP- Input 100-240 VAC ± 10 %, 50/60 Hz, 0.5 A
120200SPA Output 12.0 VDC/ 2.0 A
Dimensions Max. 88 mm x 30 mm x 57 mm
3.46” x 1.18” x 2.24”
Mode of Operation Continuous
Battery Primary lithium coin cell battery (CR2032 type) used for the
internal real time clock system
Environmental Operation: +15 °C - +35 °C / +59 °F - +95 °F
conditions: Humidity: 30 % - 90 %, non-condensing
Storage: 0 °C - +50 °C / +32 °F - +122 °F
Humidity: 10 % - 95 %, non-condensing
Transport: -20 °C - +50 °C / -4 °F - +122 °F
Humidity: 10 % - 95 %, non-condensing
Ambient 98kPa - 104 kPa
pressure:
Altitude rating Max operating altitude 2000 m / 6561 ft above sea level
Weight 1.5 kg/2.7 lbs
Dimensions W x D x H: 34.5 x 20 x 8 cm / 13.4” x 7.9” x 3.2”
Display 5.7”, TFT display, 640 x 480
User Interface Keys, control dials
Language Settings Chinese, German, English, Spanish, French, Polish, Turkish,
Russian, Japanese
Monitor Build in monitor speaker, headset
Warm-up Time Less than 1 min after power on (incl. boot-up time)
Communication Talk forward and talk back
Stimulus Functions Tone Presenter/Interrupter
Lock (tone presentation of both channels simultaneously)
Track (fixed level difference between both channels)
Masking
Data Interfaces PC Connection USB
Printer Connection USB
External Devices Audio device, USB Thermal Printer
Supported Printers HPRT HM-E300
PC Connection USB: the system cannot be operated from a PC.
Using MAICO Sessions together with the OtoAccess
Database, Noah or a Practice Management Software via
BDT/GDT-interface (only for Germany, Austria and
Switzerland), data can be transferred and saved on the PC.
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AUDIOMETRY
Patient Response One push button
Switch
Patient Talk Forward
communication
Masking Signals Narrow band noise masking for tone: IEC 60645-1 2012, 5/12
Octave filter with the same center frequency resolution as pure tone
White Noise: 80 Hz to 20 kHz measured with constant bandwidth
Speech Noise for speech: IEC 60645-2:1993 125 Hz to 6 kHz
falling 12 dB/octave above 1 kHz (+/-5 dB)
Tone: Effective Masking: ISO 389-4, ANSI S3.6
Speech: Selectable effective masking or SPL
Air Conduction DD45 RadioEar Standard Values
DD65v2 RadioEar Standard Values
IP30 ISO 389-2, ANSI S3.6 (no free-field filter applicable)
DD450 RadioEar Standard Values
HDA 300 Sennheiser Standard Values
Holmco Only for Masking with BKH10
9501 (no free-field filter applicable)
Bone Conduction B71/B81 ISO 389-3, ANSI S3.6, Mastoid Placement
(no free-field filter applicable)
BKH10 ISO 389-3, ANSI S3.6, Mastoid Placement
(no free-field filter applicable)
Sound Field SP90A ISO 389-7, ANSI S3.6
SP90 ISO 389-7, ANSI S3.6
SP85A ISO 389-7, ANSI S3.6
AP70 FF ISO 389-7, ANSI S3.6
Amplifier
Measured in free-field conditions
Transducers – DD45 Headband Static Force 4.5 N ± 0.5 N
Headband DD65v2 Headband Static Force 10 N ± 0.5 N
tension DD450 Headband Static Force 10.0 N ± 0.5 N
HDA 300 Headband Static Force 8.8 ± 0.5 N
B71/81 Headband Static Force 5.4 N ± 0.5 N
BKH10 Headband Static Force 5.4 N ± 0.5 N
(5.0 N ± 0.5 N if attached to Holmco 9501 headband)
Frequency Response (performed with pink noise)
Headphones + Frequencies IEC 60645-1 ANSI S3.6
Insert 125 Hz + 4 dB/-11 dB +0 dB/-10 dB
earphones 250 Hz to 4000 Hz ±4 dB ±3 dB
6000 Hz to 8000 Hz +4 dB/-6 dB ±5 dB
Bone Conductor Frequencies IEC 60645-1 ANSI S3.6
250 Hz to 4000 Hz +/- 10 dB at 1mW +/- 10 dB at 1mW
8521193 Rev. 3 103 27/04/2022
AUDIOMETRY
Tone Audiometry
Tone Tests HL, MCL, UCL, Aided
Special Tests High Frequency Audiometry
Pure Tone Stenger
SISI Test (Automatic test: 5, 4, 3, 2, 1 dB Increment of 250 ms
every 5 s, Response Window = 1500 ms from start of increment)
Tone Decay Test (Automatic test, Duration: 60 s)
ABLB Test (Stimulus length: 500 ms or 1000 ms)
MLB Test (Stimulus length: 500 ms or 1000 ms)
Langenbeck Test (Effective masking noise: Narrow band noise)
Inputs Sinus or warble tone (pulsed and continuous)
Outputs Left, Right, Binaural, Bone (L+R)
Accuracy Frequency ± 1 %
Distortion Total Harmonic Distortion (THD): AC: < 2.5 %, BC: < 5.5 %
Precision Level Steps: 1 dB, 2 dB or 5 dB (selectable in settings)
Stimuli Note: For details regarding frequencies and levels see section 6.4.
Tone AC: Standard: 125 Hz to 8 kHz, High Frequency: 9 kHz to 16 kHz
BC: 125 Hz to 8000 Hz
Warble Tone 5 Hz sine ± 5 % modulation
Pediatric Special narrowband noise stimulus.
Noise The bandwidth is frequency depended: 125 Hz to 250 Hz – 29 %,
500 Hz – 24%, 750 Hz – 20%, 1 kHz – 17 %, 1.5 kHz – 13 %,
2 kHz 11 %, 3 kHz – 9 % from 4 kHz and up is fix 8 %
Pulse Tone 250 ms or 500 ms on/off time (selectable in settings)
Presentation Presenter or Interrupter
Level AC: -10 dB HL to 120 dB HL
AC HF: -20 dB HL to 90 dB HL
BC: -10 dB HL to 85 dB HL
Insert phones: -10 dB HL to 120 dB HL
Sound field speaker with Amplifier: -10 dB HL to 115 dB HL
Safety limit: Level > 100 dB HL
Calibration Calibration information and instructions are located in the
MA 42 Service Manual.
Speech Audiometry
Speech Tests SRT, WRS, MCL, UCL, SRT Aided, WRS Aided
Special Tests Speech Stenger
Master Hearing Aid (High pass filters of -6 dB, -12 dB, -18 dB, -24 dB
per octave with cut off frequency of 1 kHz, HFE filter (High Frequency
Emphasis): high pass filter of -12 dB per octave with cut off
frequencies of 1 kHz and 2 kHz, which results in -24 dB per octave)
Freiburger Speech Test (Germany only)
QuickSINTM (USA only)
8521193 Rev. 3 104 27/04/2022
AUDIOMETRY
Speech Signals Microphone (Mic), Wave or external audio device (AUX)
Speech Level AC: -10 dB HL to 100 dB HL
BC: -10 dB HL to 60 dB HL
Insert phones: -10 dB HL to 95 dB HL
Sound field speaker with Amplifier: -10 dB HL to 90 dB HL
Precision Level Steps: 1 dB, 2 dB or 5 dB (selectable in settings)
Frequency Sound Pressure Level: ± 3 dB for 125 Hz to 4000 Hz and
Response ± 5 dB for 6000 Hz to 16000 Hz
(Loudspeaker) Force Level: ± 4 dB for 125 Hz to 4000 Hz and
± 5 dB for higher frequencies
Distortion Total Harmonic Distortion (THD):
Headphones, insert earphones and bone conductor output: see
tone values
Loudspeaker output: 3 % at 80 dB, 10 % at 100 dB SPL
PRINTER
Thermal Type HM-E300
printer Display OLED display
Accessories USB Cable, Paper (2 rolls), Quick Guide
Connection USB
Battery 2300 mAh/7.4 V rechargeable Li-ion battery
5 days stand-by
Charger Output: DC 5 V/1A
Battery: 2300 mAh/7.4 V rechargeable Li-ion battery
Dimension W x D x H: 106.2 mm x 139.1 mm x 61.9 mm
(4.18 in x 5.48 in x 2.44 in)
Weight 475.8 g / 17.8 oz (without paper roll)
Paper Continuous paper
Paper Width: 80 mm
Paper Thickness: 0.053 mm to 0.100 mm
Paper Roller Diameter: ≤ 50 mm
To be printed on paper roll.
Printing time <5 s per test result
8521193 Rev. 3 105 27/04/2022

6.2 Connections
8 10 12 14 16
Figure 111 1 2 3 4 5 6 7 13 15
9 11
Table 18 Connections on Backside
CONNECTIONS
No Connection socket Specification
1 On/Off Power Switch
2 Power Supply External Power supply +12V 2A (center +12V)
Model UES24LCP-120200SPA
3 USB 2.0 A Host
4 USB 2.0 B Device
5 Patient Response Switch 2 kΩ 3.3V DC
6 Talk Back Microphone Input impedance 3.4 kΩ
Min. input level 0 VU 212 µVrms 1 kHz
Max. input level 0 VU 6.6 mVrms 1 kHz
7 Mic (Microphone) Input impedance 3.4 kΩ
Min. input level 0 VU 212 µVrms 1 kHz
Max. input level 0 VU 6.6 mVrms 1 kHz
8 Monitor Phone Max voltage level 2.4 Vrms
Load impedance 4 Ω or higher
9 AUX Input Input impedance 47 kΩ
Min. input level 0 VU 16 mVrms 1 kHz
Max. input level 0 VU 500 mVrms 1 kHz
10 Speaker Left Line Max. voltage level 3 Vrms
Load impedance 2 kΩ or higher
11 Speaker Right Line Max. voltage level 3 Vrms
Load impedance 2 kΩ or higher
12 Bone (Bone Conductor) Max. voltage level 6 Vrms
Load impedance 3.3 Ω or higher
13 Insert Phone Left Max. voltage level 3 Vrms
14 Insert Phone Right Max. voltage level 3 Vrms
15 Phone Left (Headphone) Max. voltage level 3 Vrms
16 Phone Right (Headphone) Max. voltage level 3 Vrms
8521193 Rev. 3 106 27/04/2022
6.3 Pin Assignment

Socket Pin I Pin O
Connector
No. (Inner) (Outer)
2 12 V Ground
DC socket
Socket
USB
No.
1. +5 VDC
2. Data -
3 3. Data +
4. Ground
1. +5 VDC
2. Data -
4 3. Data +
4. Ground
Socket
Connector Pin 1 Pin 2 Pin 3
No.
6 Ground Signal -
6.3 mm Stereo
12, 13,
14, 15, Ground Signal -
16
5 -
6.3 mm Mono
7 Ground DC bias Signal
8, 9 Ground Right Left

3.5 mm Stereo
10,11 Ground Signal -
RCA
8521193 Rev. 3 107 27/04/2022

6.4 Calibration Values and Maximum Levels

Calibration Values and Max Levels: Headphone DD45
Coupler IEC 60318-3, PTB Report 2009, DTU Report 2010
Fre- Tone/Ped. Tone/Ped. Sound
NBN NBN
quen- Noise Noise Attenuation GF - GC
RETSPL Max Level
cy RETSPL Max Level [dB] [dB]
dB re 20µPa [dB HL]
[Hz] dB re 20µPa [dB HL] ISO 8253-1
125 47.5 51.5 85/73 65 3 -21.5

250 27.0 31.0 105/93 85 5 -12.0
500 13.0 17.0 120/108 100 7 -7.0
750 6.5 11.5 120/108 105 - -
1000 6.0 12.0 120/108 105 15 -3.5
1500 8.0 14.0 120/108 105 - -
2000 8.0 14.0 120/108 105 26 -7.0
3000 8.0 14.0 120/108 105 - -
4000 9.0 14.0 120/108 105 32 -8.0
6000 20.5 25.5 120/108 95 - -
8000 12.0 17.0 120/108 95 24 -1.5
Speech
Speech Speech White
Signal Speech Noise
Equ. FF Noise Noise
Equ. FF
IEC 60645-1 RETSPL 20.0 3.5 20.0 3.5 0.0
IEC Max Level [dB HL] 100 110 95.0 105 120
ANSI S3.6 RETSPL 18.5 18.5 18.5 18.5 0.0
ANSI Max Level [dB HL] 100 95 95.0 90 120
JIS T 1201-2 RETSPL 14.0 3.5 14.0 3.5 n/a
JIS Max Level [dB HL] 106 110 101 105 n/a
8521193 Rev. 3 108 27/04/2022

Calibration Values and Max Levels: Headphone DD65 V2

Coupler IEC 60318-1, PTB Report 2018, AAU Report 2018
Tone/Ped. NBN Tone/Ped. Sound
Fre-
Noise RETSPL Noise Max NBN Attenuation GF - GC
quency
RETSPL dB re Max Level [dB HL] [dB] [dB]
[Hz]
dB re 20µPa 20µPa [dB HL] ISO 8253-1
125 30.5 34.5 80/68 65 8.3 -4.5

250 17.0 21.0 100/88 85 15.5 -4.5
500 8.0 12.0 110/98 95 26.1 -3.0
750 5.5 10.5 115/103 100 - -
1000 4.5 10.5 115/103 100 32.4 -1.5
1500 2.5 8.5 115/103 100 - -
2000 2.5 8.5 115/103 95 43.6 -2.5
3000 2.0 8.0 115/103 100 - -
4000 9.5 14.5 110/98 95 43.8 -9.5
6000 21.0 26.0 100/88 85 - -
8000 21.0 26.0 95/82 80 45.6 -4.5
Speech
Speech Speech White
Signal Speech Noise
Equ. FF Noise Noise
Equ. FF
IEC 60645-1 RETSPL 20.0 1.5 20.0 1.5 0.0
IEC Max Level [dB HL] 85 100 80 90 110
ANSI S3.6 RETSPL 17.0 16.5 17.0 16.5 0.0
ANSI Max Level [dB HL] 90 85 85 80 110
JIS T 1201-2 RETSPL 14.0 1.5 14.0 1.5 n/a
8521193 Rev. 3 109 27/04/2022

Calibration Values and Max Levels: Headphone HDA 300

Coupler IEC 60318-1 with adapter, ANSI 3.6 and ISO 389-8/ISO 389-5
Tone/Ped. Tone/Ped. SOUND
Fre- NBN NBN
Noise Noise ATTENUA- GF - GC
quency RETSPL dB Max Level
RETSPL dB re 20µPa Max Level TION [dB] [dB]
[Hz] [dB HL]
re 20µPa [dB HL] ISO 8253-1
125 27.0 31.0 110/98 75 12.4 -12.0

250 20.0 24.0 115/103 80 12.7 -11.5
500 8.0 12.0 120/118 90 9.4 -7.5
750 4.5 9.5 120/118 95 - -
1000 2.0 8.0 120/118 95 12.8 -1.0
1500 3.0 9.0 120/118 95 - -
2000 0.0 6.0 120/118 100 15.1 -2.0
3000 -3.0 3.0 120/118 105 - -
4000 -0.5 4.5 120/118 105 28.8 -4.5
6000 21.0 26.0 105/93 90 - -
8000 23.0 28.0 100/88 85 26.2 -10.0
9000 27.5 32.5 95/83 80 - -
10000 18.0 23.0 100/88 85 - -
11200 22.0 27.0 100/88 80 - -
12500 27.0 32.0 90/78 75 - -
14000 33.5 38.5 80/68 65 - -
16000 45.5 50.5 65/53 55 - -
Speech
Speech Speech White
Signal Speech Noise
Equ. FF Noise Noise
Equ. FF
IEC 60645-1 RETSPL 20.0 1.0 20.0 1.0 0
ANSI S3.6 RETSPL 14.5 16.0 14.5 16.0 0
JIS T 1201-2 RETSPL 14.0 1.0 14.0 1.0 n/a
8521193 Rev. 3 110 27/04/2022

Calibration Values and Max Levels: Headphone DD450

Coupler IEC 60318-1 with adapter, ANSI 3.6 and ISO 389-8/ISO 389-5
Tone/Ped. Tone/Ped. SOUND
Fre- NBN NBN
Noise Noise ATTENUA- GF - GC
quency RETSPL Max Level
RETSPL Max Level TION [dB] [dB]
[Hz] dB re 20µPa [dB HL]
dB re 20µPa [dB HL] ISO 8253-1
125 30.5 34.5 90/78 65 15 -5.0

250 18.0 22.0 105/93 80 16 -4.5
500 11.0 15.0 110/98 85 23 -2.5
750 6.0 11.0 115/103 90 - -
1000 5.5 11.5 115/103 90 29 -3.5
1500 5.5 11.5 105/93 90 - -
2000 4.5 10.5 110/98 90 32 -5.0
3000 2.5 8.5 110/98 90 - -
4000 9.5 14.5 105/93 90 46 -13.0
6000 17.0 22.0 100/88 85 - -
8000 17.5 22.5 95/83 80 44 -8.5
9000 19.0 24.0 95/83 80 - -
10000 22.0 27.0 90/78 75 - -
11200 23.0 28.0 90/78 75 - -
12500 27.5 32.5 85/73 70 - -
14000 35.0 40.0 75/63 65 - -
16000 56.0 61.0 55/43 45 - -
Speech
Speech Speech White
Signal Speech Noise
Equ. FF Noise Noise
Equ. FF
IEC 60645-1 RETSPL 20.0 3.5 20.0 3.5 0.0
ANSI S3.6 RETSPL 19.0 18.5 19.0 18.5 0.0
JIS T 1201-2 RETSPL 14.0 3.5 14.0 3.5 n/a
8521193 Rev. 3 111 27/04/2022

Calibration Values and Max Levels: Headphone HOLMCO 9501

Coupler IEC 60318-1, ANSI 3.6 and ISO 389-8
Tone/Ped. NBN Tone/Ped.
Sound
Frequency Noise RETSPL Noise Max NBN
Attenuation [dB]
[Hz] RETSPL dB re Max Level [dB HL]
ISO 8253-1
dB re 20µPa 20µPa [dB HL]
125 45.0 49.0 85/73 65 3

250 27.0 31.0 105/93 90 5
500 13.5 17.5 120/118 105 7
750 9.0 14.0 120/118 105 -
1000 7.5 13.5 120/118 105 15
1500 7.5 13.5 120/118 105 -
2000 9.0 15.0 120/118 105 26
3000 11.5 17.5 115/103 95 -
4000 12.0 17.0 115/103 95 32
6000 16.0 21.0 105/93 85 -
8000 15.5 20.5 105/93 90 24
Signal Speech Speech Noise White Noise
IEC 60645-1 RETSPL 20.0 20.0 0.0

IEC Max Level [dB HL] 110 110 120
ANSI S3.6 RETSPL 20.0 20.0 0.0
ANSI Max Level [dB HL] 110 110 120
JIS T 1201-2 RETSPL 14.0 14.0 n/a
JIS Max Level [dB HL] 116 116 n/a
8521193 Rev. 3 112 27/04/2022

Calibration values and Max Levels: Insert Phones IP30

Coupler (2cc) IEC 60318-5 made in accordance to ISO 389-2, ANSI S3.6
Tone/Ped. Tone/Ped. Sound
NBN
Frequency Noise Noise Max NBN Attenuation
RETSPL
[Hz] RETSPL Max Level [dB HL] [dB]
dB re 20µPa
dB re 20µPa [dB HL] ISO 8253-1
125 26.0 30.0 90/78 85 33

250 14.0 18.0 105/93 100 36
500 5.5 9.5 110/98 105 38
750 2.0 7.0 115/103 110 -
1000 0.0 6.0 120/118 110 37
1500 2.0 8.0 120/118 110 -
2000 3.0 9.0 120/118 110 33
3000 3.5 9.5 120/118 110 -
4000 5.5 10.5 115/103 105 40
6000 2.0 7.0 100/88 95 -
8000 0.0 5.0 90/78 90 43
IEC 60645-1 RETSPL 20.0 20.0 0

ANSI S3.6 RETSPL 12.5 12.5 0
JIS T 1201-2 RETSPL 14.0 14.0 n/a
8521193 Rev. 3 113 27/04/2022

Calibration values and Max Levels: Bone Conductor B71

Coupler IEC 60318-6, mastoid placement, ISO 389-3, ANSI S3.6
Tone/Ped. Tone/Ped.
NBN
Frequency Noise Noise Max NBN Air Radiation
RETSPL
[Hz] RETSPL Max Level [dB HL] [dB]
dB re 20µPa
dB re 20µPa [dB HL]
250 67.0 71.0 45/33 35 -

500 58.0 62.0 65/53 50 -
750 48.5 53.5 70/58 55 -
1000 42.5 48.5 70/58 60 -
1500 36.5 42.5 70/58 60 80
2000 31.0 37.0 70/58 65 -
3000 30.0 36.0 70/48 55 50
4000 35.5 40.5 70/48 55 -
6000 40.0 45.0 50/38 35 -
8000 40.0 45.0 40/28 35 -
IEC 60645-1 RETSPL 55 55 42.5

ANSI S3.6 RETSPL 55 55 42.5
JIS T 1201-2 RETSPL 49 49 n/a
8521193 Rev. 3 114 27/04/2022

Calibration values and Max Levels: Bone Conductor B81

Max
Frequency Noise RETSPL Noise Air Radiation
NBN
[Hz] RETSPL dB re Max Level [dB]
[dB HL]
250 67.0 71.0 45/33 35 -

500 58.0 62.0 70/58 55 -
750 48.5 53.5 75/63 60 -
1000 42.5 48.5 80/68 60 -
1500 36.5 42.5 85/73 70 80
2000 31.0 37.0 80/68 65 -
3000 30.0 36.0 75/63 55 50
4000 35.5 40.5 70/58 50 -
6000 40.0 45.0 50/38 40 -
8000 40.0 45.0 40/28 30 -
IEC 60645-1 RETSPL 55 55 42.5

8521193 Rev. 3 115 27/04/2022

Calibration values and Max Levels: Bone Conductor BKH10

Max
Frequency Noise RETSPL Noise Air Radiation
NBN
[Hz] RETSPL dB re Max Level [dB]
[dB HL]
125 82.5 86.5 40/28 25 -

250 67.0 71.0 50/38 35 -
500 58.0 62.0 55/43 40 -
750 48.5 53.5 60/48 45 -
1000 42.5 48.5 65/53 50 -
1500 36.5 42.5 70/58 55 0
2000 31.0 37.0 70/58 55 0
3000 30.0 36.0 70/58 55 0
4000 35.5 40.5 60/48 45 0
6000 40.0 45.0 55/43 40 0
8000 40.0 45.0 45/33 40 0
IEC 60645-1 RETSPL 55 55 42.5

8521193 Rev. 3 116 27/04/2022

Calibration values: Sound field

Reference equivalent threshold sound pressure level and maximum hearing levels
For SP90A, SP90, SP85A and AP70FF Amplifier
ANSI S3.6:2010 Sound Field max. SPL
For Sound Field max. HL
ISO 389-7:2005 subtract the selected
RETSPL value
Binaural to
Binaural Free Field Line
Monaural
Frequency Tone/Ped.
0° 45° 90° Correction NBN
[Hz] Noise
RETSPL RETSPL RETSPL RETSPL Max. SPL
Max. SPL [dB]
[dB] [dB] [dB] [dB] [dB]
125 22.0 21.5 21.0 2 102.0/90.0 97.0

250 11.5 10.5 9.5 2 106.5/94.5 101.5
500 4.5 1.5 0.0 2 104.5/92.5 99.5
750 2.5 -1.0 -2.5 2 102.5/90.5 97.5
1000 2.5 -1.5 -3.0 2 102.5/90.5 97.5
1500 2.5 -1.0 -2.5 2 102.5/90.5 97.5
2000 -1.5 -4.5 -3.5 2 103.5/91.5 98.5
3000 -6.0 -11.0 -8.5 2 104.0/92.0 94.0
4000 -5.5 -9.5 -5.0 2 104.5/92.5 99.5
6000 4.5 -3.0 -5.0 2 104.5/92.5 99.5
8000 12.5 7.0 4.0 2 92.5/80.5 87.5
White
0.0 -4.0 -5.5 2 - 100
Noise
Sound Field max.

ANSI S3.6:2010
SPL
For Sound Field max.
ISO 389-7:2005 HL subtract the
selected RETSPL value
Binaural to
Binaural Free Field Line
Monaural
0° 45° 90° 135° 180° Correction 0° - 45° - 90°
RETSPL RETSPL RETSPL RETSPL RETSPL RETSPL
Max. SPL [dB]
[dB] [dB] [dB] [dB] [dB] [dB]
Speech 15.0 11.0 9.5 10.0 13.0 2 100.0

Speech
15.0 11.0 9.5 10.0 13.0 2 100.0
Noise
Speech
17.5 13.5 12.0 12.5 15.5 2 97.5
WN
8521193 Rev. 3 117 27/04/2022
6.5 Electromagnetic Compatibility (EMC)

ESSENTIAL PERFORMANCE for this device is defined by the manufacturer as:
• This device does not have an ESSENTIAL PERFORMANCE
• Absence or loss of ESSENTIAL PERFORMANCE cannot lead to any
unacceptable immediate risk. Final diagnosis shall always be based on clinical
knowledge.
This device is in compliance with IEC 60601-1-2:2014, emission class B group 1
NOTICE: There are no deviations from the collateral standard and allowances uses.
NOTICE: All necessary instruction for maintaining compliance with regard to EMC can be
found in the general maintenance section in this instruction. No further steps required.
To ensure compliance with the EMC requirements as specified in IEC 60601-1-2, it is

essential to use only the accessories listed in the following table. Conformance to the
EMC requirements as specified in IEC 60601-1-2 is ensured if the cable types and
cable lengths are as specified.
Cable
Item Manufacturer Model Length Screened
[m] (Yes/No)
Audiometric Headphones RadioEar DD45 2.0 Yes
Audiometric Headphones RadioEar DD65v2 2.0 Yes
High Frequency Headphones RadioEar DD450 2.0 Yes
High Frequency Headphones Sennheiser HDA 300 2.0 Yes
Insert Earphone RadioEar IP30 2.0 Yes
Bone conductor RadioEar B71 2.0 No
Bone conductor RadioEar B81 2.0 No
Bone conductor MAICO BKH10 2.0 No
Monitor Headset
Sennheiser PC3.2 IA Ed 2.0 Yes
with microphone
Talk Back Microphone RadioEar EM400 2.0 Yes
Patient response switch RadioEar APS3 2.0 Yes
UES24LCP-
Power Supply (Wall plug) UE / Fuhua 1.5 No
120200SPA
USB cable for printer (A/micro) Sanibel 8105182 2.0 Yes
Printer HPRT HM-E300 - -
Electromagnetic Compatibility (EMC)

Portable and mobile RF communications equipment can affect the MA 42. Install and operate the MA 42 according to the EMC
information presented in this chapter.
The MA 42 has been tested for EMC emissions and immunity as a standalone MA 42. Do not use the MA 42 adjacent to or stacked with
other electronic equipment. If adjacent or stacked use is necessary, the user should verify normal operation in the configuration.
The use of accessories, transducers and cables other than those specified, with the exception of servicing parts sold by MAICO as
replacement parts for internal components, may result in increased EMISSIONS or decreased IMMUNITY of the device.
Anyone connecting additional equipment is responsible for making sure the system complies with the IEC 60601-1-2 standard.
Guidance and manufacturer’s declaration - electromagnetic emissions

The MA 42 is intended for use in the electromagnetic environment specified below. The customer or the user of the MA 42 should
assure that it is used in such an environment.
Emissions Test Compliance Electromagnetic environment - guidance
RF emissions Group 1 The MA 42 uses RF energy only for its internal function.
CISPR 11 Therefore, its RF emissions are very low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions Class B The MA 42 is suitable for use in all commercial, industrial, business, and
CISPR 11 residential environments.
Harmonic emissions Not Applicable
IEC 61000-3-2
Voltage fluctuations / Not applicable
flicker emissions
IEC 61000-3-3
Recommended separation distances between

portable and mobile RF communications equipment and the MA 42.
The MA 42 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or
the user of the MA 42 can help prevent electromagnetic interferences by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the MA 42 as recommended below, according to the maximum output
power of the communications equipment.
Separation distance according to frequency of transmitter
Rated Maximum output [m]
power of transmitter
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.7 GHz
[W]
d = 1.17√P d = 1.17√P d = 2.23√+P
0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.74
1 1.17 1.17 2.33
10 3.70 3.70 7.37
100 11.70 11.70 23.30
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be
estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
Note 1 At 80 MHz and 800 MHZ, the higher frequency range applies.
Note 2 These guidelines may not apply to all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity

The MA 42 is intended for use in the electromagnetic environment specified below. The customer or the user of the MA 42 should
assure that it is used in such an environment.
Immunity Test IEC 60601 Test level Compliance Electromagnetic environment - guidance
Electrostatic Floors should be wood, concrete or ceramic
± 8 kV contact ± 8 kV contact
Discharge (ESD) tile. If floors are covered with synthetic
material, the relative humidity should be
± 15 kV air ± 15 kV air
IEC 61000-4-2 greater than 30%.
± 2 kV for power supply lines Not applicable

Electrical fast
100kHz repetition frequency
transient/burst Mains power quality should be that of a
typical commercial or residential environment.
± 1 kV Line-to-line ± 1 kV Line-to-line
IEC61000-4-4
100kHz repetition frequency
Surge ± 1 kV Line-to-line
Mains power quality should be that of a
Not applicable
IEC 61000-4-5 ± 2 kV Line-to-ground
0% UT for 0.5 cycle
Mains power quality should be that of a
Voltage dips, short
0 % UT for 1 cycle typical commercial or residential environment.
interruptions and
If the user of the MA 42 requires continued
voltage variations on
and Not applicable operation during power mains interruptions, it
power supply lines
is recommended that the MA 42 be powered
70% UT from an uninterruptable power supply or its
IEC 61000-4-11
for 25/30 cycles battery.
Single phase: at 0°
Power frequency
Power frequency magnetic fields should be at
(50/60 Hz)
30 A/m 30 A/m levels characteristic of a typical location in a
IEC 61000-4-8
Note: UT is the A.C. mains voltage prior to application of the test level.
Guidance and manufacturer’s declaration — electromagnetic immunity

The MA 42 is intended for use in the electromagnetic environment specified below. The customer or the user of the MA 42 should assure
that it is used in such an environment,
Immunity test IEC / EN 60601 test level Compliance level Electromagnetic environment – guidance
Portable and mobile RF communications
equipment should be used no closer to any
parts of the MA 42, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency
of the transmitter.
Recommended separation distance:
Conducted RF 3 Vrms 3 Vrms d = 1,2 P

IEC / EN 61000-4-6 150kHz to 80 MHz
6 Vrms in ISM bands 6 Vrms
150kHz to 80 MHz
80 % AM at 1 kHz
Radiated RF 3 V/m 3 V/m d = 1, 2 P 80 MHz to 800 MHz
IEC / EN 61000-4-3 80 MHz to 2,7 GHz d = 2,3 P 800 MHz to 2,7 GHz
80 % AM at 1 kKz
Where P is the maximum output power rating
of the transmitter in watts (W) according to
the transmitter manufacturer and d is the
recommended separation distance in meters
(m).
Field strengths from fixed RF transmitters, as

determined by an electromagnetic site
survey,a should be less than the compliance
level in each frequency range.b
Interference may occur in the vicinity of

equipment marked with the following symbol:
NOTE1 At 80 MHz and 800 MHz, the higher frequency range applies
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.
a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur
radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which the MA 42 is used exceeds the applicable RF compliance level above, the MA 42 should be observed to verify normal
operation, If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the MA 42.
b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
6.6 Electrical Safety, EMC and Associated Standards
1. IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012(or IEC
60601-1: 2012 reprint)/ANSI/AAMI ES60601-1:2015+A2::2010+A1:2012/CAN/CSA-
C22.2 No. 60601-1:14: Medical electrical equipment - Part 1: General requirements for
basic safety and essential performance
2. IEC/EN 60601-1-2:2014: Medical Electrical Equipment, Part 1 - Electromagnetic
Compatibility - Requirements and Tests
3. General Safety and Performance Requirements of the current REGULATION (EU)
2017/745
4. 2011/65/EU of 8 June 2011 on the restriction of the use of certain hazardous
substances in electrical and electronic equipment (RoHS)
5. Directive 2002/96/EC of the European Parliament and of the Council of
27 January 2003 on waste electrical and electronic equipment (WEEE)
6.7 Checklist for subjective Audiometer Testing

Specifications are subject to change
MAICO Diagnostics GmbH

Sickingenstr. 70-71
10553 Berlin
Germany
Tel.: + 49 30 / 70 71 46-50
Fax: + 49 30 / 70 71 46-99
E-mail: sales@maico.biz
Internet: www.maico.biz

IFU Om-Ma42-En-2022

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Operation Manual

8521193 Rev. 3 1 27/04/2022

Title: MA 42 – Operation Manual

MAICO Diagnostics GmbH

Copyright © 2022 – MAICO Diagnostics.

8521193 Rev. 3 2 27/04/2022

1.1 Intended Use Statement

8521193 Rev. 3 3 27/04/2022

Section 5.9.6 License Management

8521193 Rev. 3 4 27/04/2022

1.4.8 Master Hearing Aid (MHA)

8521193 Rev. 3 6 27/04/2022

1.4.14 Freiburger Speech Test

1.4.16.2 Hearing Level (HL)

1.4.16.3 Most Comfortable Level (MCL)

1.4.16.4 Uncomfortable Level (UCL)

8521193 Rev. 3 7 27/04/2022

1.4.16.5 HL Aided (Configuration Dependent)

1.4.16.6 Speech Recognition Threshold (SRT)

1.4.16.7 Word Recognition Score (WRS)

1.4.16.8 SRT Aided and WRS Aided

8521193 Rev. 3 8 27/04/2022

For your Safety

2.1 How to read this Operation Manual

READ THIS ENTIRE MANUAL BEFORE ATTEMPTING TO USE THIS

The WARNING label identifies conditions or practices that may

CAUTION The CAUTION label identifies conditions or practices that could

The information sign displays alternative documents or

8521193 Rev. 3 9 27/04/2022

2.2 Customer Responsibility

This product and its components perform reliably only when

2.3 Manufacturer’s Liability

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2.4 Regulatory Symbols

Caution, consult accompanying documents

Warning, consult accompanying documents

Information sign (reference for more detailed information)

Return to authorized representative, special disposal required

REF Reference number

Refer to operation manual (mandatory)

Keep away from rain

Transport and storage temperature range

Transport and storage humidity limitations

CE label with notified body ID

Non-ionizing electromagnetic radiation

Direct Current (DC)

ETL listed mark

2.5 General Precautions

In case of emergency, disconnect the device from the

In case of emergency, disconnect the device from power

8521193 Rev. 3 12 27/04/2022

To transfer data to a PC, establishing a PC-connection via USB is

Establishing a Connection to a PC,

8521193 Rev. 3 13 27/04/2022

The device is not intended for operation in areas with an

To avoid the risk of electric shock, this equipment must only be

Prevent cable breakage: cables must not be bend or buckled.

2.7 Electromagnetic Compatibility (EMC)

Section 6.5 Electromagnetic Compatibility (EMC)

Portable RF communications equipment (including peripherals

8521193 Rev. 3 14 27/04/2022

2.8 Battery Safety

WARNING Batteries may explode or cause burns, if disassembled,