Skip to content

Bernafon 153897

by Bernafon, Inc.

Bernafon 153897 is a Class II device made by Bernafon, Inc., listed in FDA GUDID since 21 Sep 2016 (UDI-DI 05711584055533), 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 Number05711584055533 UDI-DI Date21 Sep 2016ListedStatusListed 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  • Withdrawn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
Air-conduction hearing aid, in-the-ear
Model / reference
153897
Primary DI / UDI-DI
05711584055533
FDA product code
OSM
GMDN term
Air-conduction hearing aid, in-the-ear
Device class
Class II
Regulation number
874.3305
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Air-conduction hearing aid, in-the-ear

Other devices from Bernafon, Inc.

See all devices from Bernafon, Inc. →

Properties

  • Prescription use
  • Premarket exempt
  • Serial number
Other properties (12, all answered No)