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Tinnitus Phase-Out Masker

by Tinnitus Control, Inc.

510(k) K061111

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK061111 Date16 May 2006ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
Tinnitus Phase-Out
510(k) Number
FDA Product Code
KLW
Device Class
Class II
Regulation
21 CFR Part 874.3400
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Tinnitus Phase-Out Masker is a tinnitus masker, classified as a Class II device under FDA regulation 874.3400. It is designed to mitigate tinnitus symptoms by delivering personalized sound therapy to help patients manage auditory perceptions.

This device is supplied as a reusable treatment unit paired with custom-recorded sound files. It is intended for use in clinical or home settings and requires no specific sterility beyond standard hygiene practices. Authorized under FDA 510(k) clearance (K061111), it adheres to regulatory standards for ear, nose, and throat applications, with no MRI safety restrictions noted.

Other devices from Tinnitus Control, Inc.

  • Tinnitus Rx

    Class II

Questions

AI-generated answers, 19 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 Tinnitus Phase-Out Masker and how does it work?

    The Tinnitus Phase-Out Masker is designed to help patients manage tinnitus symptoms by delivering personalized sound therapy. It works by providing auditory stimulation that can help mask or reduce the perception of tinnitus, allowing users to regain a sense of auditory comfort. The device is reusable and paired with custom-recorded sound files tailored to the user’s needs.

  • Is the Tinnitus Phase-Out Masker intended for use in clinical settings only, or can it also be used at home?

    The device is approved for use in both clinical and home settings. Its design allows flexibility for patients to manage their tinnitus symptoms in environments where they spend the most time, whether that’s a healthcare facility or their personal residence.

  • How is the Tinnitus Phase-Out Masker supplied, and what should I know about its maintenance?

    The device comes as a reusable treatment unit paired with custom-recorded sound files. Since it is reusable, standard hygiene practices should be followed to ensure cleanliness and proper functionality. No specific sterility requirements beyond general cleanliness are mentioned in the documentation.

  • Are there any restrictions on using the Tinnitus Phase-Out Masker with MRI machines?

    The documentation does not mention any MRI safety restrictions for the Tinnitus Phase-Out Masker, meaning it should not interfere with MRI procedures. However, always verify with your facility’s MRI safety protocols before use, as individual settings may vary.

  • What regulatory pathway was followed for the approval of the Tinnitus Phase-Out Masker?

    The device was cleared through the FDA’s 510(k) pathway, specifically under the classification of a Class II medical device (regulatory number 874.3400). It was determined to be substantially equivalent to a predicate device and received a special clearance (K061111) in 2006, with the Ear, Nose, and Throat (EN) advisory committee overseeing the review.