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Hearing Aid, Air Conduction, Transcutaneous System

FDA product code NIX · 1 cleared devices

Class 2 Ear, Nose, Throat
Regulation
21 CFR 874.3950
Review panel
EN
Implant
Yes
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2004-08-20 – 2004-08-20

The transcutaneous air conduction hearing aid system is a wearable sound-amplifying device that is intended to compensate for impaired hearing. It consists of an air conduction hearing aid attached to a surgically fitted tube system. The tube creates an air channel through the soft tissue between outer ear canal and the post-auricular region of the pinna (ear). The air conduction hearing aid attaches to the post-auricular opening of the tube, thereby transmiting amplified sound to the ear canal without occluding the canal.

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