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Oticon 158594

by Oticon A/S

Oticon 158594 is a Class II device made by Oticon A/S, listed in FDA GUDID since 5 Oct 2016 (UDI-DI 05707131296931), registry data as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05707131296931 UDI-DI Date5 Oct 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  • Withdrawn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
Oticon
Generic name
Air-conduction hearing aid, canal
Model / reference
158594
Primary DI / UDI-DI
05707131296931
FDA product code
OSM
GMDN term
Air-conduction hearing aid, canal
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, canal

Other devices from Oticon A/S

See all devices from Oticon A/S →

Properties

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