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Bernafon 132561

by Bernafon, Inc.

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.

Overview

Bernafon is a battery-powered acoustic device designed to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. This compact, in-the-canal (ITC) or completely-in-the-canal (CIC) hearing aid offers mild to moderately-severe hearing loss treatment with programmable adjustments for computerized changes.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05711584050880 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  • Withdrawn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, canal
Model / reference
132561
Primary DI / UDI-DI
05711584050880
FDA product code
LRB
GMDN term
Air-conduction hearing aid, canal
Device class
Class I
Regulation number
874.3300
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Air-conduction hearing aid, canal

Similar devices in this category

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Properties

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