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Tympanic Membrane Direct Contact Hearing Aid

FDA product code PLK · 2 cleared devices

Class 2 Ear, Nose, Throat
Regulation
21 CFR 874.3315
Review panel
EN
Implant
Yes
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2016-04-06 – 2019-01-25

A tympanic membrane contact hearing aid is intended to compensate for impaired hearing by transmitting amplified sound by vibrating the tympanic membrane through a transducer that is in direct contact with the tympanic membrane.

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