CDSCO risk classification
ENT medical device classification
Every ent device in CDSCO's classification register, with its risk class under the Medical Devices Rules, 2017 and its intended use. 56 are Class A non-sterile, non-measuring devices, which are exempt from licensing but must be registered.
- Devices
- 128
- Class A
- 72
- Class B
- 35
- Class C
- 19
- Class D
- 2
ENT devices and their class
128 devices
Acoustic chamber for audiometric testing
ENT
Class ANon-sterile, non-measuringAn acoustic chamber for audiometric testing is a room that is intended for use in conducting diagnostic hearing evaluations and that eliminates sound reflections and provides isolation from outside sounds.
Active implantable bone conduction hearing system
ENT
Class CThe active implantable bone conduction hearing system is intended to compensate for conductive or mixed hearing losses by conveying amplified acoustic signals to the cochlea via mechanical vibrations on the skull bone.
Adenotome
ENT
Class ASurgical instrument intended to dissect the adenoids.
Adenotome blade
ENT
Class BIntended to mount on adenotome and perform dissection of adenoids.
Adenotome blade, reusable
ENT
Class ANon-sterile, non-measuringA blade intended to be mounted into the handle of an adenotome to excise the adenoids during an adenoidectomy. This is a reusable device.
Adenotome, reusable
ENT
Class ANon-sterile, non-measuringA hand-held manual surgical instrument intended to excise pharyngeal tonsils or adenoids during a procedure known as an adenoidectomy. This is a reusable, transient-use device.
An endolymphatic shunt tube with valve
ENT
Class CIt is a device that consists of a pressure-limiting valve associated with a tube intended to be implanted in the inner ear to relieve symptoms of vertigo and hearing loss.
Antistammering device
ENT
Class BAn antistammering device intended to minimize a user's involuntary hesitative or repetitive speech. It also prevent the user from hearing the sounds of his or her own voice
Argon laser for otology, rhinology, and laryngology
ENT
Class CDevice is used for the purpose of coagulating and vaporizing soft and fibrous tissues, including osseous tissue while performing ENT surgical procedure.
Audiometer
ENT
Class BIntended for evaluation of hearing by generating tones throughout the audible range
Audiometer testing system
ENT
Class AAn assembly of electronic reference devices intended to calibrate an audiometer.
Battery-powered artificial larynx
ENT
Class BA battery-powered artificial larynx is an externally applied device intended for use in the absence of the larynx to produce sound.
Behind-the-ear air- conduction hearing aid
ENT
Class BIntended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air.
Behind-the-ear air- conduction tinnitus masker
ENT
Class BIntended to provide noise of sufficient intensity and bandwidth to mask tinnitus.
Behind-the-ear bone- conduction tinnitus masker
ENT
Class CIntended to provide ultrasonic broadband noise and/or sweep-frequency stimuli noise of sufficient intensity and bandwidth to mask tinnitus.
Bone particle collector
ENT
Class AA bone particle collector is a filtering device intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.
Cochlear implant
ENT
Class DA cochlear implant is an implanted electronic hearing device, designed to produce useful hearing sensations to a person with severe to profound nerve deafness by electrically stimulating nerves inside the inner ear.
Cochlear implant assessment system
ENT
Class CIntended to perform an integrity test on the implantable portion of a cochlear implant (CI) system in-situ.
Ear bowl
ENT
Class ANon-sterile, non-measuringConstructed to fit the curvature of the head so that it will sit closely under the ear lobe and enable treatments of ear.
Ear canal impression tray
ENT
Class ANon-sterile, non-measuringIntended to hold and confine the impression material in opposition to the surfaces to be recorded, and to control the impression material while it sets to form the impression of the ear canal.
Ear canal light
ENT
Class ANon-sterile, non-measuringIntended to illuminate the ear canal.
Ear excavator
ENT
Class ADesigned for cutting, scraping, scooping and removing tissue during a surgical procedure in or around the ear.
Ear hook, reusable
ENT
Class ANon-sterile, non-measuringA hand-held, manual surgical instrument intended to be used in surgery of the middle ear. This is a reusable device intended for transient use.
Ear Irrigation kit
ENT
Class ANon-sterile, non-measuringA collection of non-sterile items intended to irrigate the ear canal with solution to clear wax and debris. It may consist of curette, forceps, a manually-operated flushing device (e.g., spray bottle, syringe, etc.) and accessory items (e.g., a cup to collect used irrigation solution). This is a reusable device.
Ear Mould
ENT
Class BA preformed device intended to fit in an ear canal and through which the amplified sound from a hearing aid is conveyed into the ear canal for compensating for hearing loss. This is a reusable device.
Ear prosthesis
ENT
Class CIntended to reconstruct the external ear by replacing damaged or missing tissue.
Ear speculum, reusable / Ear cannula, reusable
ENT
Class ANon-sterile, non-measuringA device that is hand-held and manually inserted into the ear canal to create a channel for examination, suction, irrigation, or the insertion of another surgical device during an ear/nose/throat (ENT) procedure. It might also be referred to as an ear probe. This is not intended for long-term use and cannot connect to high-risk active devices. This is a reusable device.
Ear wick
ENT
Class AIntended to minimize bleeding during ear surgery.
Ear, nose, and throat electric or pneumatic surgical drill
ENT
Class BAn ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur for the controlled incision or removal of bone in the ear, nose, and throat area.
Ear, nose, and throat microsurgical carbon dioxide laser
ENT
Class CDevice intended for the surgical excision of tissue from the ear, nose, and throat area while performing microsurgical procedures to excise lesions and tumors of the vocal cords and adjacent areas.
Earmould impression kit
ENT
Class ANon-sterile, non-measuringA collection of non-sterile, non-active supplies, instruments, and materials intended to be used to make an accurate impression of the folds and convolutions of cartilage that form the outer ear and its canal (i.e., an earmould). The mould of the ear is used to manufacture custom-made hearing devices such as hearing aids and earplugs.
Earmould impression material
ENT
Class ANon-sterile, non-measuringA silicone impression moulding material intended to take an impression to manufacture a shell or ear mould to the correct size to fit an individual's ear.
Electroglottograph
ENT
Class BIntended for recording the changes in electrical potential or impedance, resulting from movement of the vocal cords during respiration and phonation.
Elevator, ear/nose/throat
ENT
Class ANon-sterile, non-measuringA hand-held, manually-operated, surgical instrument intended to lift, position or pry anatomical structures or surgical material during ear/nose/throat (ENT) surgery. It does not have any additional intended uses. This is a reusable device.
Endaural curette
ENT
Class ADesigned for scraping within the ear canal (e.g., removing wax), and for procedures during middle ear surgery (e.g., removal of the superior bony rim).
Endaural wax extraction curette
ENT
Class ANon-sterile, non-measuringA hand-held, manual, non-surgical device intended to scrape within the ear canal primarily for the extraction of ear wax during an ear/nose/throat (ENT) procedure it is not intended for surgical scraping or manipulation of tissues.
Endolymphatic shunt
ENT
Class CIntended to be implanted to relieve the symptoms of vertigo.
Endolymphatic Shunt Tube
ENT
Class BDuring a surgical procedure in which it is placed in the membranous labyrinth of the inner ear to drain excess fluid.
ENT chair, electric
ENT
Class ADesigned to support a patient in a seated position, electrically control position in a way to facilitate ear, nose, throat examination, treatment, and/or minor surgery.
ENT chair, electric without operative unit
ENT
Class ANon-sterile, non-measuringIntended to support a patient in a seated position, electrically control position in a way to facilitate ear, nose, throat examination, treatment, and/or minor surgery. This does not include any diagnostic or surgical instruments.
ENT chair, mechanical
ENT
Class ADesigned to support a patient in a seated position, mechanically control position in a way to facilitate ear, nose, throat examination, treatment, and/or minor surgery.
ENT chair, mechanical without operative unit
ENT
Class ANon-sterile, non-measuringIntended to support a patient in a seated position, mechanically control position in a way to facilitate ear, nose, throat examination, treatment, and/or minor surgery. This does not include any diagnostic or surgical instruments.
ENT cupped forceps
ENT
Class AA forcep with a spoon-(dish) like configuration at the distal end, and is used to treat the ear, nose, and throat (ENT), and remove tissue from the body.
ENT foreign body extraction forceps, reusable
ENT
Class ANon-sterile, non-measuringA hand-held, manual, non-surgical device intended to be inserted into the nasal or ear canal to grip and extract a foreign body/debris (e.g., ear wax) during an ear/nose/throat (ENT) procedure it is not intended for surgical grasping or manipulation of tissues. This is a reusable device.
ENT illuminating foreign body extraction set
ENT
Class ANon-sterile, non-measuringA collection of devices which includes a foreign body extraction instrument (typically a curette or forceps), and an electrically-powered light source, and a magnifying lens intended to be inserted into the nasal or ear canal to grip and extract a foreign body/debris (e.g., ear wax) during an ear/nose/throat (ENT) procedure it is not intended for surgical grasping or manipulation of tissues. It is supplied non-sterile and is non- measuring.
ENT illuminator
ENT
Class ANon-sterile, non-measuringIntended to assist with examinations by illuminating regions of the eye mount or ear. It does not have a measuring function.
ENT Nasal snare
ENT
Class AA hand-held manual surgical instrument intended to be inserted into the naris for the removal of tissue, typically polyps, tumours, and other abnormal tissue from the nasal cavity during ear/nose/throat (ENT) surgery
ENT Nasal snare, reusable
ENT
Class ANon-sterile, non-measuringA hand-held manual surgical instrument intended to be inserted into the naris for the removal of tissue, typically polyps, tumours, and other abnormal tissue from the nasal cavity during ear/nose/throat (ENT) surgery. This is a reusable device. This is not an active device.
ENT shaver system
ENT
Class BIntended to resect/debride soft and osseous (bone) tissue in the nasal cavity or ear region during ear/nose/throat (ENT) or plastic surgery procedures; including functional endoscopic sinus surgery (FESS).
Class taken from Merged existing medical devices risk classification, entry ENT 20, because the register feed omits it.
ENT speculum holder
ENT
Class ANon-sterile, non-measuringA device intended to be used to secure an ear/nose/throat (ENT) speculum in a fixed position to enable a surgeon to remain hands- free during a surgical intervention. This is a reusable device.
ENT surgical excavator, reusable
ENT
Class ANon-sterile, non-measuringAn ear, nose, and throat reusable manual surgical instrument intended for use or to assist in use in surgical procedures to examine the bronchus, esophagus, trachea, larynx, pharynx, nasal and paranasal sinus, or ear. This is a reusable device intended to be sterilized prior to use.
ENT surgical microscope
ENT
Class ANon-sterile, non-measuringIntended to magnify minute structures (e.g., nerves, vessels) in the performance of ear, nose, and/or throat (ENT) surgery requiring high magnification and adjustable focusing.
ENT transilluminator
ENT
Class ANon-sterile, non-measuringIntended to illuminate sinus tissue during an ear/nose/throat (ENT) procedure to render the tissue translucent for examination
Epistaxis balloon
ENT
Class BDevice intended to control internal nasal bleeding by exerting pressure against the sphenopalatine artery.
Esophagoscope (flexible or rigid)
ENT
Class BDevice intended to examine or treat esophageal malfunction symptoms, esophageal or mediastinal disease, or to remove foreign bodies from the esophagus.
Eustachian Catheter
ENT
Class BIt is used to test Eustachian tube patency.
Eustachian tube balloon dilation system
ENT
Class BThe system is intended for use in dilating the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction.
Evoked response auditory stimulator
ENT
Class BAn evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.
Evoked-potential audiometer
ENT
Class BElectroacoustic instrument designed to evaluate the activity of the auditory pathway of the brain in response to an acoustic signal [auditory brainstem response (ABR)] in patients.
External nasal splint
ENT
Class ANon-sterile, non-measuringAn external nasal splint is a rigid or partially rigid device intended for use externally for immobilization of parts of the nose.
External upper esophageal sphincter compression device
ENT
Class CAn external upper esophageal sphincter compression device is intended to apply external pressure on the cricoid cartilage for the purpose of reducing the symptoms of laryngopharyngeal reflux disease.
Flexible fibreoptic nasopharyngo laryngoscope
ENT
Class BFlexible endoscope intended for the visual examination and treatment of the nasal passages, including the sinus openings, the pharyngeal end of the auditory tube, the larynx, and the vocal cords.
Flexible fibreoptic nasopharyngoscope
ENT
Class BFlexible endoscope intended for the visual examination and treatment of nasopharynx (the upper part of the throat behind the nose).
Flexible fibreoptic rhinoscope
ENT
Class BFlexible endoscope intended for the visual examination and treatment of nasal cavity.
Flexible fibreoptic sinoscope
ENT
Class BFlexible endoscope intended for the visual examination and treatment of the paranasal sinuses during an ear/nose/throat (ENT) intervention.
Flexible video antroscope
ENT
Class BFlexible endoscope intended for the visual examination and treatment of a cavity, particularly the pathological changes in the area of the maxillary sinus.
Forceps, ear/nose/throat/ENT forceps, reusable
ENT
Class ANon-sterile, non-measuringA general-purpose ear/nose/throat (ENT) manual surgical instrument intended to facilitate the grasping, holding, or manipulation of anatomical structures (e.g., trachea, ear) or devices (e.g., cochlear implant electrode array) during ENT procedures. This is a transient-use, reusable device intended to be sterilized prior to use.
Fully-implantable middle ear implant system
ENT
Class CAn implanted assembly of sterile devices intended to compensate for impaired hearing by transmitting vibrations to the middle ear. It is powered by a battery that is recharged inductively, via an external device.
Gustometer
ENT
Class BA gustometer is a battery-powered device that consists of two electrodes that are intended to provide galvanic stimulus resulting in taste sensation.
Hearing aid calibrator and analysis system
ENT
Class BA hearing aid calibrator and analysis system is an electronic reference device intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid, master hearing aid, group hearing aid or group auditory trainer.
Hearing Aid Sound Delivery System
ENT
Class BA component of a Behind-the-ear (BTE) hearing aid consisting of a receiver encased in an ear mould, intended to transmit amplified sound waves from a compatible hearing aid to the ear canal to support moderate to severe hearing loss. This is a reusable device.
Hearing Prosthesis System
ENT
Class CThe prostheses are intended for partial ossicular replacement to restore functionality to the middle ear.
Hook, surgical, rhinoplasty, reusable
ENT
Class ANon-sterile, non-measuringA hand-held, manual surgical instrument intended to be used in plastic surgery of the nose. This is a reusable device intended for transient use.
Impedance audiometer
ENT
Class BIntended to evaluate the functional condition of the middle ear by changing the air pressure in the external auditory canal to measure and graph the mobility characteristics of the tympanic membrane.
In-the-ear Air Conduction Hearing Aid
ENT
Class BA battery-powered device intended to compensate for impaired hearing by amplifying sound waves and transmitting them to the eardrum via air conduction. It typically consists of a miniature microphone, amplifier, and speaker (receiver) contained in a case that fits completely inside the outer ear (in-the-ear (ITE)).
Infant acoustic earmuffs, ENT
ENT
Class ANon-sterile, non-measuringA device intended to cover ears of neonates/infants to provide noise insulation in a special care unit.
Intranasal Splint, non-bioabsorbable
ENT
Class AA sterile, non-biodegradable/non-absorbable device intended to be temporarily placed via a nostril into the nasal cavity after surgery or trauma to help minimize bleeding by tamponade effect. It may also be used to prevent adhesions between the mucosal surfaces, and/or to provide support to the surrounding tissues during the healing period. It is not an implant. This is a single-use device intended for short-term.
Lacrimal tube insertion hook/pusher, reusable
ENT
Class ANon-sterile, non-measuringA hand-held manual instrument intended for introducing a lacrimal tube/stent into the canaliculi, nasolacrimal duct, and/or nasal cavity through the corner of the eye, during a lacrimal intubation procedure for treating pathologies of the tear drainage system. This is a reusable device.
Laryngeal knife, reusable
ENT
Class ANon-sterile, non-measuringA hand-held manual surgical instrument intended to cut and dissect laryngeal tissue, including the vocal cords, during ear/nose/throat (ENT) surgery. This is a reusable device intended to be sterilized prior to use.
Laryngeal mirror, reusable
ENT
Class ANon-sterile, non-measuringA hand-held manual surgical instrument with a mirror or a surface sufficiently polished to reflect enough undiffused light to form a virtual image of an object placed before it at the distal end, intended to be used for a laryngeal examination. This is a reusable device.
Laryngostroboscope
ENT
Class BA laryngostroboscope is a device that is intended to allow observation of glottic action during phonation.
Larynx prosthesis
ENT
Class CA device used for replacement and restoration of the laryngeal function, or for maintenance of patency of the larynx.
Master hearing aid
ENT
Class BA master hearing aid is an electronic device intended to simulate a hearing aid during audiometric testing.
Mastoid chisel, reusable
ENT
Class ANon-sterile, non-measuringA hand-held, manual surgical instrument intended to cut and shape the mastoid process (the large projection of the temporal bone of the skull found immediately behind each ear) during ear/nose/throat (ENT) surgery. This is a reusable device.
Mediastinoscope and accessories
ENT
Class BDevice intended to examine or treat tissue in the area separating the lungs for diagnosis of tumors and lesions and to determine whether excision of certain organs or tissues is indicated.
Middle ear chisel, reusable
ENT
Class ANon-sterile, non-measuringA hand-held surgical instrument intended for manually cutting or contouring the bones of the middle ear, otological microsurgery, stapedotomy, and related ear/nose/throat (ENT) surgery. This is a reusable device.
Middle ear malleus nipper/ hook/anvil, reusable
ENT
Class ANon-sterile, non-measuringA hand-held manual surgical instrument intended to be used to cut the malleus (hammer-shaped lateral bone in the middle ear). This is a reusable device intended for transient use.
Middle ear mold
ENT
Class CA middle ear mold is a preformed device that is intended to be implanted to reconstruct the middle ear cavity during repair of the tympanic membrane.
Middle ear pick, reusable
ENT
Class ANon-sterile, non-measuringA fine, hand-held manual surgical instrument intended to be used to manipulate the structures of the middle ear (e.g., the stapes). This is a reusable device intended for transient use.
Nasal aspirator, manual
ENT
Class ANon-sterile, non-measuringA portable, hand-held, manual suction device intended to enable an adult to gently suction and clear excessive mucus from the nasal passages of an infant or child to facilitate easier breathing.
Nasal chisel, reusable
ENT
Class ANon-sterile, non-measuringA hand-held surgical instrument intended for manually cutting or shaping nasal bones, otological microsurgery, stapedotomy, and related ear/nose/throat (ENT) surgery. This is a reusable device.
Nasal dilator
ENT
Class ANon-sterile, non-measuringA nasal dilator is a device intended to provide temporary relief from transient causes of breathing difficulties resulting from structural abnormalities and/or transient causes of nasal congestion associated with reduced nasal airflow.
Nasal Irrigation kit
ENT
Class ANon-sterile, non-measuringA collection of non-sterile instruments intended to cleanse or flush the nasal passages and sinus cavity with saline for postoperative, preventive, or symptomatic nasal care.
Nasal irrigation kit, pediatric
ENT
Class ANon-sterile, non-measuringA collection of non-sterile instruments intended to irrigate the nasal passages of infants and young children.
Nasal scissors, reusable
ENT
Class ANon-sterile, non-measuringA hand-held, manual, surgical instrument used to cut tissue during ear/nose/throat (ENT) or plastic surgery in or on the nose and its associated structures. This is a transient-use reusable device intended for transient use.
Nasal septum straightening forceps
ENT
Class ANon-sterile, non-measuringSurgical instrument specifically designed to straighten the nasal septum through grasping and manipulation of the bone/cartilage of the septum during nasal reconstructive procedures.
Nasal speculum, reusable
ENT
Class ANon-sterile, non-measuringA hand-held surgical instrument intended to be inserted into a nostril and manually expanded to maximally open the nostril by stretching the tissue around the nasal orifice, allowing access for examination or ear/nose/throat (ENT) surgical intervention. This is a reusable device.
Nasogastric tube holder, intranasal, short-term use
ENT
Class ANon-sterile, non-measuringA non-sterile, non-surgically invasive, device intended to be used with enteral feeding tubes to prevent inadvertent removal or displacement of the tubes for adult patients. Not intended for long- term use.
Nasogastric tube holder, non-sterile
ENT
Class ANon-sterile, non-measuringThis device is intended to secure nasogastric tubes to skin near and around the nose.
Nebulizer
ENT
Class CIt is device used to administer medications in the form of mist to inhale for respiratory disorders.
Otoscope cover, non-sterile
ENT
Class ANon-sterile, non-measuringA device intended to fit onto and cover an otoscope to form a physical barrier protecting patients against cross contamination.
Otoscope, direct
ENT
Class ANon-sterile, non-measuringA portable, battery-powered, hand-held device (non-endoscopic) primarily designed for examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening.
Otoscope, endoscopic
ENT
Class AIntended to be used in otology mainly for observation, diagnosis, and treatment of the outer and/or middle ear.
Powered nasal irrigator
ENT
Class BA powered nasal irrigator is an AC-powered device intended to wash the nasal cavity by means of a pressure-controlled pulsating stream of water.
Retractor, ear/nose/throat, reusable
ENT
Class ANon-sterile, non-measuringA manual surgical instrument intended for separating or drawing aside the margins of a surgical incision made during ear/nose/throat (ENT) surgery or various structures of these anatomical locations. This is a reusable device for transient use only.
Rigid Optical Sinoscope
ENT
Class BAn endoscope with a rigid inserted portion intended for the visual examination, diagnosis and treatment of the paranasal sinuses during an ear/nose/throat (ENT) intervention. It is inserted through a naris. It may be used in connection with a camera and external light source.
Scissors, ear/ Alligator scissors, reusable
ENT
Class ANon-sterile, non-measuringA long, thin, hand-held manual surgical instrument intended to cut tissue during ear surgery it is not intended for insertion through an endoscope. This is a reusable device for transient use.
Scissors, tonsil, reusable
ENT
Class ANon-sterile, non-measuringA hand-held surgical instrument intended to cut tonsil tissue during ear/nose/throat (ENT) surgery. This is a reusable device intended for transient use.
Scissors, wire cutting, ENT
ENT
Class ANon-sterile, non-measuringA hand-held manual surgical instrument intended to cut wire used to construct ossicular replacements. This is a reusable device.
Self-retaining ear speculum, reusable
ENT
Class ANon-sterile, non-measuringA hand-held manual instrument intended for expanding or stretching the tissue around the ear orifice when inserted and opened, typically during ear/nose/throat (ENT) intervention. It does not have any additional features/intended purposes and cannot connect to high-risk active devices. This is a reusable device.
Soft-tissue surgical forceps, alligator
ENT
Class AA long, thin, hand-held manual surgical instrument designed to facilitate grasping and manipulation of soft-tissues/anatomical structures [typically during ear/nose/throat (ENT) surgery].
Suction antichoke device
ENT
Class CA suction antichoke device is a device intended to be used in an emergency situation to remove, by the application of suction, foreign objects that obstruct a patients airway to prevent asphyxiation to the patient.
Tongs antichoke device
ENT
Class CA tongs antichoke device is a device that is intended to be used in an emergency situation to grasp and remove foreign objects that obstruct a patients airway to prevent asphyxiation of the patient.
Tongue depressor
ENT
Class ANon-sterile, non-measuringA surgical instrument used to move the tongue to facilitate examination of surrounding organs and tissue.
Tongue-retaining sleep- disordered breathing orthosis
ENT
Class ANon-sterile, non-measuringA removable intraoral device intended to alleviate sleep-disordered breathing conditions (e.g., snoring, obstructive sleep apnoea) by retention of the tongue, frequently keeping the tongue in a forward position during sleep.
Tonsil knife
ENT
Class AIntended for the removal of the tonsils during a surgical intervention.
Tonsil knife, reusable
ENT
Class ANon-sterile, non-measuringA hand-held, manual surgical instrument intended to be used in surgery of the anatomical features of the tonsils and their remoal. This is a reusable device.
Tonsil Suction Tube
ENT
Class BUsed to suck out stones in tonsils.
Tonsillectome
ENT
Class AA manually operated surgical device used to dissect the tonsils.
Total ossicular replacement prosthesis
ENT
Class DIt is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear.
Tracheal bistoury
ENT
Class ADesigned for opening abscesses or slitting up sinuses and/or fistulas in the trachea.
Tracheal bistoury, reusable
ENT
Class ANon-sterile, non-measuringA hand-held, manual surgical instrument intended for opening abscesses or slitting up sinuses and/or fistulas in the trachea. This is a reusable device.
Transcutaneous air conduction hearing aid system
ENT
Class CA transcutaneous air conduction hearing aid system is a wearable sound-amplifying device intended to compensate for impaired hearing without occluding the ear canal.
Tuning fork, ENT
ENT
Class ANon-sterile, non-measuringA non-powered, non-invasive device intended to test the hearing acuity of a patient, to diagnose hearing disorders, and to test for vibratory sense.
Tympanic membrane contact hearing aid
ENT
Class BA tympanic membrane contact hearing aid is a prescription device that compensates for impaired hearing by vibrating the tympanic membrane through a transducer that is in direct contact with the tympanic membrane.
Tympanostomy Tube
ENT
Class CIt is a small tube inserted into the eardrum in order to keep the middle ear aerated for a prolonged period of time, and to prevent the accumulation of fluid in the middle ear.
Voice / laryngeal Prosthesis
ENT
Class CThe device is intended to direct pulmonary air flow to the pharynx in the absence of the larynx, for permitting esophageal speech.
Wireless air-conduction hearing aid
ENT
Class BA wireless air-conduction hearing aid is intended to compensate for impaired hearing that incorporates wireless technology in its programming or use.
Data from CDSCO's online system for medical devices, retrieved 2026-10-31.
Sources
- Risk Classification Approved Device Details, CDSCO online system for medical devices. Retrieved 31 October 2026.
- Merged existing medical devices risk classification, CDSCO public notice, 1 January 2025.
See the full source list and how the data is compiled on the main classification page. This is a reference aid, not legal or regulatory advice.
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