FDA product code OSM: Hearing Aid, Air-Conduction With Wireless Technology, Prescription
OSM is the FDA product code for hearing aid, air-conduction with wireless technology, prescription. It is a Class II device, regulated under 21 CFR 874.3305 and reviewed by the Ear, Nose and Throat panel. Devices under OSM reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
A wireless air-conduction hearing aid is a wearable sound-amplifying device, intended to compensate for impaired hearing that incorporates wireless technology in its programming or use. This is a prescprition hearing aid.
Classification
| Field | Value |
|---|---|
| Device name | Hearing Aid, Air-Conduction With Wireless Technology, Prescription |
| Device class | Class II |
| Regulation | 21 CFR 874.3305 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) exempt |
Recalls for OSM devices
openFDA lists no recalls for product code OSM.
Frequently asked questions
What is FDA product code OSM?
OSM is the FDA product code for hearing aid, air-conduction with wireless technology, prescription. It is a Class II device, regulated under 21 CFR 874.3305 and reviewed by the Ear, Nose and Throat panel.
What device class is OSM?
Class II, regulation 21 CFR 874.3305. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code OSM
- Run a recall and safety report across every OSM manufacturer
- Watch product code OSM 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.
All Ear, Nose and Throat product codes · FDA product code lookup · 510(k) database search · 510(k) review times