NIX — Hearing Aid, Air Conduction, Transcutaneous System Class II
FDA product code NIX covers "Hearing Aid, Air Conduction, Transcutaneous System", a Class II medical device regulated under 21 CFR 874.3950. Submissions are reviewed by the Ear, Nose, Throat panel. Devices under this code are implants. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NIX
- Device Class
- Class II
- Regulation Number
- 874.3950
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- Yes
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.