Appendix A

File No. 29/Misc/03/2020-DC(196)

Drugs Controller General (India)
Directorate General of Health Services
FDA Bhawan, Kotla Road, New Delhi.

Notice
Classification of Medical Devices Pertaining to ENT

Sr.
Medical Device Name
No.
1 Adenotome
2 Adenotome blade
3 Audiometer testing system
4 Audiometer
Evoked response auditory
5 B
stimulator
Behind-the-ear air-
6 transmitting amplified sound waves to the eardrum
conduction hearing aid
Risk
Intended Use
Class
Surgical instrument intended to dissect the
A
adenoids.
Intended to mount on adenotome and perform
B
dissection of adenoids.
An assembly of electronic reference devices
A
intended to calibrate an audiometer.
Intended for evaluation of hearing by generating
B
tones throughout the audible range
An evoked response auditory stimulator is a
device that produces a sound stimulus for use in
evoked response measurements or
electroencephalogram activation.
Intended to compensate for impaired hearing by
B
through air.

Behind-the-ear air- Intended to provide noise of sufficient intensity and

7 B
conduction tinnitus masker bandwidth to mask tinnitus.

Intended to provide ultrasonic broadband noise

Behind-the-ear bone-
8 and/or sweep-frequency stimuli noise of sufficient C
conduction tinnitus masker
intensity and bandwidth to mask tinnitus.
Intended to perform an integrity test on the
Cochlear implant
9 implantable portion of a cochlear implant (CI) C
assessment system
system in-situ.
Constructed to fit the curvature of the head so that
10 Ear bowl it will sit closely under the ear lobe and enable A
treatments of ear.
Intended to hold and confine the impression
material in opposition to the surfaces to be
11 Ear canal impression tray recorded, and to control the impression material A
while it sets to form the impression of the ear
canal.
12 Ear canal light Intended to illuminate the ear canal. A

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 Designed for cutting, scraping, scooping and
13 Ear excavator removing tissue during a surgical procedure in or A
around the ear.
Intended to reconstruct the external ear by
14 Ear prosthesis C
replacing damaged or missing tissue.
15 Ear wick Intended to minimize bleeding during ear surgery. A
Intended for recording the changes in electrical
potential or impedance, resulting from movement
16 Electroglottograph B
of the vocal cords during respiration and
phonation.
Designed for scraping within the ear canal (e.g.,
removing wax), and for procedures during middle
17 Endaural curette A
ear surgery (e.g., removal of the superior bony
rim).
Designed to support a patient in a seated position,
electrically control position in a way to facilitate
18 ENT chair, electric A
ear, nose, throat examination, treatment, and/or
minor surgery.
Designed to support a patient in a seated position,
mechanically control position in a way to facilitate
19 ENT chair, mechanical A
ear, nose, throat examination, treatment, and/or
minor surgery.
Intended to resect/debride soft and osseous
(bone) tissue in the nasal cavity or ear region
20 ENT shaver system during ear/nose/throat (ENT) or plastic surgery B
procedures; including functional endoscopic sinus
surgery (FESS).
Intended to magnify minute structures (e.g.,
nerves, vessels) in the performance of ear, nose,
21 ENT surgical microscope A
and/or throat (ENT) surgery requiring high
magnification and adjustable focusing.
Intended to illuminate sinus tissue during an
22 ENT transilluminator ear/nose/throat (ENT) procedure to render the A
tissue translucent for examination
Electroacoustic instrument designed to evaluate
the activity of the auditory pathway of the brain in
23 Evoked-potential audiometer B
response to an acoustic signal [auditory brainstem
response (ABR)] in patients.
Flexible endoscope intended for the visual
examination and treatment of the nasal passages,
Flexible fibreoptic
24 including the sinus openings, the pharyngeal end B
nasopharyngo laryngoscope
of the auditory tube, the larynx, and the vocal
cords.
Flexible endoscope intended for the visual
Flexible fibreoptic
25 examination and treatment of nasopharynx (the B
nasopharyngoscope
upper part of the throat behind the nose).

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 Flexible endoscope intended for the visual
26 Flexible fibreoptic rhinoscope B
examination and treatment of nasal cavity.
Flexible endoscope intended for the visual
examination and treatment of the paranasal
27 Flexible fibreoptic sinoscope B
sinuses during an ear/nose/throat (ENT)
intervention.
Flexible endoscope intended for the visual
examination and treatment of a cavity, particularly
28 Flexible video antroscope B
the pathological changes in the area of the
maxillary sinus.
Intended to evaluate the functional condition of the
middle ear by changing the air pressure in the
29 Impedance audiometer B
external auditory canal to measure and graph the
mobility characteristics of the tympanic membrane.
Surgical instrument specifically designed to
Nasal septum straightening straighten the nasal septum through grasping and
30 A
forceps manipulation of the bone/cartilage of the septum
during nasal reconstructive procedures.
Intended to be used in otology mainly for
31 Otoscope, endoscopic observation, diagnosis, and treatment of the outer A
and/or middle ear.
Intended for the removal of the tonsils during a
32 Tonsil knife A
surgical intervention.
Designed for opening abscesses or slitting up
33 Tracheal bistoury A
sinuses and/or fistulas in the trachea.
A middle ear mold is a preformed device that is
intended to be implanted to reconstruct the middle
34 Middle ear mold C
ear cavity during repair of the tympanic
membrane.
An implanted assembly of sterile devices intended
to compensate for impaired hearing by transmitting
Fully-implantable middle ear
35 vibrations to the middle ear. It is powered by a C
implant system
battery that is recharged inductively, via an
external device.
A device used for replacement and restoration of
36 Larynx prosthesis the laryngeal function, or for maintenance of C
patency of the larynx.
Device intended to control internal nasal bleeding
37 Epistaxis balloon by exerting pressure against the sphenopalatine B
artery.
The system is intended for use in dilating the
Eustachian tube balloon
38 cartilaginous portion of the Eustachian tube for B
dilation system
treating persistent Eustachian tube dysfunction.
Device is used for the purpose of coagulating and
Argon laser for otology, vaporizing soft and fibrous tissues, including
39 C
rhinology, and laryngology osseous tissue while performing ENT surgical
procedure.

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 Device intended for the surgical excision of tissue
Ear, nose, and throat from the ear, nose, and throat area while
40 microsurgical carbon dioxide performing microsurgical procedures to excise C
laser lesions and tumors of the vocal cords and adjacent
areas.
Device intended to examine or treat esophageal
Esophagoscope (flexible or malfunction symptoms, esophageal or mediastinal
41 B
rigid) disease, or to remove foreign bodies from the
esophagus.
Device intended to examine or treat tissue in the
Mediastinoscope and area separating the lungs for diagnosis of tumors
42 B
accessories and lesions and to determine whether excision of
certain organs or tissues is indicated.
A laryngostroboscope is a device that is intended
43 Laryngostroboscope to allow observation of glottic action during B
phonation.
A bone particle collector is a filtering device
intended to be inserted into a suction tube during
44 Bone particle collector A
the early stages of otologic surgery to collect bone
particles for future use.
A suction antichoke device is a device intended to
be used in an emergency situation to remove, by
45 Suction antichoke device the application of suction, foreign objects that C
obstruct a patient's airway to prevent asphyxiation
to the patient.
A tongs antichoke device is a device that is
intended to be used in an emergency situation to
46 Tongs antichoke device grasp and remove foreign objects that obstruct a C
patient's airway to prevent asphyxiation of the
patient.
A powered nasal irrigator is an AC-powered device
47 Powered nasal irrigator intended to wash the nasal cavity by means of a B
pressure-controlled pulsating stream of water.
An external nasal splint is a rigid or partially rigid
48 External nasal splint device intended for use externally for A
immobilization of parts of the nose.
An antistammering device intended to minimize a
user's involuntary hesitative or repetitive speech. It
49 Antistammering device B
also prevent the user from hearing the sounds of
his or her own voice
An external upper esophageal sphincter
External upper esophageal compression device is intended to apply external
50 sphincter compression pressure on the cricoid cartilage for the purpose of C
device reducing the symptoms of laryngopharyngeal
reflux disease.

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 A wireless air-conduction hearing aid is intended
Wireless air-conduction to compensate for impaired hearing that
51 B
hearing aid incorporates wireless technology in its
programming or use.
A hearing aid calibrator and analysis system is an
electronic reference device intended to calibrate
Hearing aid calibrator and and assess the electroacoustic frequency and
52 B
analysis system sound intensity characteristics emanating from a
hearing aid, master hearing aid, group hearing aid
or group auditory trainer.
A tympanic membrane contact hearing aid is a
prescription device that compensates for impaired
Tympanic membrane contact
53 hearing by vibrating the tympanic membrane B
hearing aid
through a transducer that is in direct contact with
the tympanic membrane.
A master hearing aid is an electronic device
54 Master hearing aid intended to simulate a hearing aid during B
audiometric testing.
The active implantable bone conduction hearing
system is intended to compensate for conductive
Active implantable bone
55 or mixed hearing losses by conveying amplified C
conduction hearing system
acoustic signals to the cochlea via mechanical
vibrations on the skull bone.
A battery-powered artificial larynx is an externally
Battery-powered artificial
56 applied device intended for use in the absence of B
larynx
the larynx to produce sound.
A nasal dilator is a device intended to provide
temporary relief from transient causes of breathing
57 Nasal dilator difficulties resulting from structural abnormalities A
and/or transient causes of nasal congestion
associated with reduced nasal airflow.
A transcutaneous air conduction hearing aid
Transcutaneous air
system is a wearable sound-amplifying device
58 conduction hearing aid C
intended to compensate for impaired hearing
system
without occluding the ear canal.
An acoustic chamber for audiometric testing is a
room that is intended for use in conducting
Acoustic chamber for
59 diagnostic hearing evaluations and that eliminates A
audiometric testing
sound reflections and provides isolation from
outside sounds.
A gustometer is a battery-powered device that
consists of two electrodes that are intended to
60 Gustometer B
provide galvanic stimulus resulting in taste
sensation.

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 A forcep with a spoon-(dish) like configuration at
the distal end, and is used to treat the ear, nose,
61 ENT cupped forceps A
and throat (ENT), and remove tissue from the
body.
A surgical instrument used to move the tongue to
62 Tongue depressor facilitate examination of surrounding organs and A
tissue.
A manually operated surgical device used to
63 Tonsillectome A
dissect the tonsils.
A hand-held manual surgical instrument intended
to be inserted into the naris for the removal of
64 ENT Nasal snare tissue, typically polyps, tumours, and other A
abnormal tissue from the nasal cavity during
ear/nose/throat (ENT) surgery
A portable, battery-powered, hand-held device
(non-endoscopic) primarily designed for
65 Otoscope, direct examination of the outer ear canal and tympanic A
membrane (eardrum) by direct viewing through the
ear opening.
A long, thin, hand-held manual surgical instrument
Soft-tissue surgical forceps, designed to facilitate grasping and manipulation of
66 A
alligator soft-tissues/anatomical structures [typically during
ear/nose/throat (ENT) surgery].
An ear, nose, and throat electric or pneumatic
surgical drill is a rotating drilling device, including
Ear, nose, and throat electric the handpiece, that is intended to drive various
67 B
or pneumatic surgical drill accessories, such as an ear, nose, and throat bur
for the controlled incision or removal of bone in the
ear, nose, and throat area.

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