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Earlens Tympanic Lens, Right
Details
Device typeTympanic membrane contact hearing aid tympanic transducer: An electronic component of a tympanic membrane (TM) contact hearing aid intended to be placed in direct contact with the TM and to convert signals into vibrations, which are then passed along the normal sound conduction pathway in the middle ear. The TM transducer is non-surgically placed by a healthcare professional in a clinical setting and is intended to remain in situ indefinitely. The hearing aid is intended to compensate for mild/severe sensorineural impaired hearing by transmitting transduced sound waves, via light waves or an oscillating electromagnetic field, to a vibrator component in direct contact with the TM.
FDA categoryTympanic Membrane Direct Contact Hearing Aid
Device ID00850013007578
Catalog numberITL01R
AvailabilityPrescription
MRI safetyMR Unsafe