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HearYou HearYou ONE

by Otc Hearing 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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860010946206 UDI-DI Date15 Oct 2023ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
HearYou
Generic Name
Air-conduction hearing aid, behind-the-ear
Model / Reference
HearYou ONE
Primary DI / UDI-DI
00860010946206
FDA Product Code
QUF
GMDN Term
Air-conduction hearing aid, behind-the-ear
Device Class
Class I
Regulation Number
874.3300
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Related devices

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

Properties

  • Single Use
  • Over-the-Counter
  • Premarket Exempt
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No