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Audiosync Via Edge Ai 2400 Bte R

by Starkey Laboratories Inc.

Audiosync Via Edge Ai 2400 Bte R is a Class II device made by Starkey Laboratories Inc., listed in FDA GUDID since 11 Mar 2020 (UDI-DI 00842318178046), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00842318178046 UDI-DI Date11 Mar 2020ListedStatusListed 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  • Withdrawn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
Audiosync
Generic name
Tinnitus masking application software
Model / Ref / Catalog
AUDIOSYNC VIA EDGE AI 2400 BTE R, 63196-J, 63207-J
Primary DI / UDI-DI
00842318178046
FDA product code
OSM, KLW
GMDN term
Tinnitus masking application software
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, behind-the-earTinnitus masking application software

Other devices from Starkey Laboratories Inc.

See all devices from Starkey Laboratories Inc. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)