OSM — Hearing Aid, Air-Conduction With Wireless Technology, Prescription Class II
FDA product code OSM covers "Hearing Aid, Air-Conduction With Wireless Technology, Prescription", a Class II medical device regulated under 21 CFR 874.3305. Submissions are reviewed by the Ear, Nose, Throat panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- OSM
- Device Class
- Class II
- Regulation Number
- 874.3305
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN100025 | office research in clinical amplifiction | WIDEXLINK IN CLEAR SERIES HEARING AIDS | March 31, 2011 |