Hearing Aid, Air Conduction, Transcutaneous System
The Transcutaneous Air Conduction Hearing Aid System is a wearable sound-amplifying device intended to compensate for impaired hearing, consisting of an air conduction hearing aid attached to a surgically fitted tube system that creates an air channel through soft tissue between the outer ear canal and the post-auricular region, transmitting amplified sound to the ear canal without occluding it. It is classified as FDA Class 2 (Special Controls), requiring 510(k) clearance, under product code NIX and regulation 21 CFR 874.3950 in the Ear, Nose, and Throat specialty. Notably, the device is flagged as an implant due to the surgically fitted tube component, though it is not life-sustaining.
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Basic Information
- Product Code
- NIX
- Device Class
- FDA class 2
- Regulation Number
- 874.3950
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- Submission Type
- 1
Device Characteristics
Definition
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.