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ANMP (Acoustic Neuro Modulation Protocol)

by Tinnitech, Ltd.

510(k) K030791

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 · Traditional NumberK030791 Date17 Apr 2003ClearedStatusActive

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  • Withdrawn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)

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, 6 Oct 2026

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

ANMP (Acoustic Neuro Modulation Protocol) is a tinnitus masker device classified under medical specialty Ear, Nose, Throat. It is a substantially equivalent device cleared via the traditional 510(k) pathway under product code KLW and regulation number 874.3400.

The device is supplied as a system comprising two mini compact discs and a portable stereo MP3 mini compact disc player with earphones. The discs contain prerecorded relaxation music and sounds spectrally adjusted to the patient's audiogram, including tinnitus masking sounds and selected musical sounds to promote relaxation and habituation. It is intended for use in clinical or personal settings as part of tinnitus management.

Questions

AI-generated answers, 6 Oct 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 ANMP device used for?

    The ANMP (Acoustic Neuro Modulation Protocol) device is intended for use in clinical or personal settings as part of tinnitus management, providing tinnitus masking sounds and relaxation music spectrally adjusted to the patient's audiogram to promote habituation.

  • How is the ANMP device supplied and what does it include?

    The ANMP device is supplied as a system comprising two mini compact discs and a portable stereo MP3 mini compact disc player with earphones, where the discs contain prerecorded relaxation music and sounds spectrally adjusted to the patient's audiogram.

  • Is the ANMP device reusable or single-use?

    The ANMP device is designed for repeated use, as it includes a portable stereo MP3 player and mini compact discs that can be used multiple times in clinical or personal settings for ongoing tinnitus management.