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Model TM2-BEHIND-THE-EAR Tinnitus

by Starkey Laboratories, Inc.

510(k) K792214

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK792214 Date27 Nov 1979ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
BWF
Device class
Class II
Regulation
21 CFR Part 868.5690
Advisory committee
Anesthesiology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Model Tm2-Behind-The-Ear Tinnitus is a medical device designed to assist individuals experiencing tinnitus, which is the sensation of prolonged noise or ringing in the ears. It is worn behind the ear to provide relief for patients associated with this condition.

This device has received FDA 510(k) clearance under the submission number K792214. It is manufactured by Starkey Laboratories, Inc. and is categorized under the anesthesiology medical specialty.

Other devices from Starkey Laboratories Inc.

See all devices from Starkey Laboratories Inc. →

Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of the Model TM2-Behind-The-Ear Tinnitus?

    This device is designed to assist individuals who experience tinnitus, which is defined as the sensation of prolonged ringing or noise in the ears. It is worn behind the ear to provide relief for patients associated with this condition.

  • Who is the manufacturer of this tinnitus device?

    The Model TM2-Behind-The-Ear Tinnitus is manufactured by Starkey Laboratories, Inc., located in McHenry, Illinois.

  • Has this device received regulatory authorization?

    Yes, this device has received FDA 510(k) clearance under the submission number K792214. This indicates that the device was found to be substantially equivalent to other legally marketed devices.