NIX
- Product code
- NIX
- Device name
- Hearing Aid, Air Conduction, Transcutaneous System
- Device class
- Class 2
- 21 CFR
- 21 CFR 874.3950
- Medical specialty
- Ear, Nose, Throat
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 2
FDA classification 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.
Official FDA classification page: NIX
Classification and pathway per current FDA publications. Data from openFDA (CC0).