FDA product code NIX: Hearing Aid, Air Conduction, Transcutaneous System
NIX is the FDA product code for hearing aid, air conduction, transcutaneous system. It is a Class II device, regulated under 21 CFR 874.3950 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 1 510(k) submission under NIX. The average 510(k) review took 126 days (median 126). 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Hearing Aid, Air Conduction, Transcutaneous System |
| Device class | Class II |
| Regulation | 21 CFR 874.3950 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every NIX clearance
Top NIX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Gyrus Ent LLC | 1 | 2004-08-20 |
Most recent NIX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K040996 | Gyrus Ent LLC | RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING AID SYSTEM | 2004-08-20 | 126 |
Recalls for NIX devices
openFDA lists no recalls for product code NIX.
Frequently asked questions
What is FDA product code NIX?
NIX is the FDA product code for hearing aid, air conduction, transcutaneous system. It is a Class II device, regulated under 21 CFR 874.3950 and reviewed by the Ear, Nose and Throat panel.
What device class is NIX?
Class II, regulation 21 CFR 874.3950. Typical premarket route: 510(k).
How long does a 510(k) take for product code NIX?
Across 1 cleared submissions the average was 126 days from receipt to decision (median 126).
Which companies have the most NIX clearances?
Gyrus Ent LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NIX
- Run a recall and safety report across every NIX manufacturer
- Watch product code NIX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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