OSM
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Hearing Aid, Air-Conduction With Wireless Technology, Prescription
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3305
- Medical specialty
- Ear, Nose, Throat
- FDA 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.
- Adverse events (MAUDE)
- 2021: 16 · 2022: 101 · 2023: 158 · 2024: 188 · 2025: 73 · 2026: 55
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| WIDEXLINK IN CLEAR SERIES HEARING AIDS (DEN100025) | Office Research IN Clinical Amplifiction | 2011-03-31 |
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Every clearance here is in the API, with alerts when new ones post.