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Phonak 063-0446-01

by Phonak AG

Phonak 063-0446-01 is an air-conduction hearing aid (FDA Class II; FDA product code OSM, Hearing aid, air conduction with wireless technology) made by Phonak AG, listed in FDA GUDID since 12 Sep 2016 (UDI-DI 07612847943728), registry data as of 12 Nov 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 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07612847943728 UDI-DI Date12 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  • Withdrawn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
Phonak
Generic name
Air-conduction hearing aid, in-the-ear
Model / Ref / Catalog
063-0446-01
Primary DI / UDI-DI
07612847943728
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 Phonak AG

See all devices from Phonak AG →

Properties

  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)