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AudioSync Aris AI mRIC R (TIER DEMO)

by Starkey Laboratories Inc.

AudioSync Aris AI mRIC R (TIER DEMO) is a Class II device made by Starkey Laboratories Inc., listed in FDA GUDID since 27 Aug 2025 (UDI-DI 00840388210772), 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 Number00840388210772 UDI-DI Date27 Aug 2025ListedStatusListed 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  • Withdrawn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 / reference
AudioSync Aris AI mRIC R (TIER DEMO)
Primary DI / UDI-DI
00840388210772
FDA product code
KLW, OSM
GMDN term
Tinnitus masking application software
Device class
Class II
Regulation number
874.3400, 874.3305
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Air-conduction hearing aid, receiver-in-canalTinnitus 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)