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Bernafon 139771

by Bernafon, Inc.

Bernafon 139771 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 23 Jul 2018 (UDI-DI 05711584094044), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05711584094044 UDI-DI Date23 Jul 2018ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Bernafon
Generic name
Hearing aid/implant system remote control
Model / reference
139771
Primary DI / UDI-DI
05711584094044
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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Properties

  • Premarket exempt
Other properties (14, all answered No)