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Birdsong 280746

by Sbo Hearing A/S

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

Overview

Birdsong AOXT5 MNR T SABE is a battery-powered acoustic device designed to compensate for impaired hearing in mild to profound loss, using amplified sound waves transmitted through an air-conduction setup. This non-invasive, receiver-in-the-ear (RITE) device can be programmed to adjust hearing levels based on individual needs.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05714464160174 UDI-DI Date5 Jan 2025ListedStatusListed 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  • Withdrawn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
Birdsong
Generic Name
Air-conduction hearing aid, receiver-in-the-ear
Model / Reference
280746
Primary DI / UDI-DI
05714464160174
FDA Product Code
OSM, KLW
GMDN Term
Air-conduction hearing aid, receiver-in-the-ear
Device Class
Class II
Regulation Number
874.3305, 874.3400
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Related devices

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

Other devices from Sbo Hearing A/S

See all devices from Sbo Hearing A/S →

Properties

  • Prescription Use
  • Serial Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No