Bernafon 185786
Bernafon 185786 is a hearing aid/implant system remote control (FDA Class II; FDA product code OSM, Hearing aid, air conduction with wireless technology) made by Bernafon, Inc., listed in FDA GUDID since 5 Jan 2018 (UDI-DI 05711584083192), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number05711584083192 | Date5 Jan 2018 | StatusListed |
Official records
- AccessGUDID record 05711584083192
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Bernafon
- Generic name
- Hearing aid/implant system remote control
- Model / reference
- 185786
- Primary DI / UDI-DI
- 05711584083192
- FDA product code
- OSM
- GMDN term
- Hearing aid/implant system remote control
- Device class
- Class II
- Regulation number
- 874.3305
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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- STARKEY STARLINK REMOTE CONTROL 2.0 by Starkey Laboratories Inc.