KLW · Class II · 21 CFR 874.3400

FDA Product Code KLW: Masker, Tinnitus

Leading manufacturers include Starkey Laboratories, Inc., Gn Resound A/S and Audifon-USA, Inc..

78
Total
78
Cleared
114d
Avg days
1977
Since
Declining activity - 2 submissions in the last 2 years vs 4 in the prior period
Review times increasing: avg 145d recently vs 113d historically

FDA 510(k) Cleared Masker, Tinnitus Devices (Product Code KLW)

78 devices
1–24 of 78
Cleared Aug 13, 2026
Levo Gen 2 Tinnitus Therapy System
K260413
Levo Medical Corporation
Ear, Nose, Throat · 185d
Cleared Jun 10, 2026
Tinnitus Therapy
K260614
Sivantos GmbH
Ear, Nose, Throat · 105d
Cleared Feb 27, 2024
Peace N Quiet (0.7.0)
K233435
Pnq Health
Ear, Nose, Throat · 137d
Cleared Jun 30, 2023
Tinearity G1 (6103)
K223694
Duearity AB
Ear, Nose, Throat · 203d
Cleared Feb 01, 2023
Tinnitogram Signal Generator
K221168
Goldenear Company, Inc.
Ear, Nose, Throat · 285d
Cleared Jan 04, 2023
SilentCloud
K221125
Aureliym GmbH
Ear, Nose, Throat · 261d
Cleared Jun 19, 2020
Multiflex Tinnitus Technology
K201370
Starkey Laboratories, Inc.
Ear, Nose, Throat · 28d
Cleared Feb 20, 2020
Tinnitus Sound Generator Module
K193303
GN Hearing A/S
Ear, Nose, Throat · 83d
Cleared Nov 30, 2018
Tinnitus Sound Generator Module
K180495
GN Hearing A/S
Ear, Nose, Throat · 277d
Cleared Jul 13, 2018
Tinnitus Sound Generator Module
K181586
GN Hearing A/S
Ear, Nose, Throat · 28d
Cleared Oct 19, 2017
audifon Tinnitus-Module
K171243
Audiofon USA, Inc.
Ear, Nose, Throat · 174d
Cleared May 17, 2017
TinniLogic Mobile Tinnitus Management Device
K163094
Jiangsu Betterlife Medical Co., Ltd.
Ear, Nose, Throat · 194d
Cleared Sep 28, 2016
Sound Options Tinnitus Treatment
K161562
Sound Options Tinnitus Treatments, Inc.
Ear, Nose, Throat · 114d
Cleared Aug 23, 2016
HyperSound Tinnitus Module
K161331
Turtle Beach Corporation
Ear, Nose, Throat · 103d
Cleared Jan 20, 2016
Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System
K151558
Neurotherapies Reset GmbH
Ear, Nose, Throat · 224d
Cleared Oct 09, 2015
REVE134
K151719
Kw Ear Lab, Inc.
Ear, Nose, Throat · 106d
Cleared Jul 27, 2015
Serenity
K150014
Sanuthera, Inc.
Ear, Nose, Throat · 203d
Cleared May 14, 2015
Tinnitus Sound Generator Module
K150171
Gn Resound A/S
Ear, Nose, Throat · 108d
Cleared Apr 13, 2015
SoundCure Serenade Tinnitus Treatment System
K150065
Soundcure, Inc.
Ear, Nose, Throat · 90d
Cleared Jul 18, 2014
LEVO TINNITUS MASKING SOFTWARE DEVICE
K140845
Otoharmonics Corp
Ear, Nose, Throat · 107d
Cleared Mar 25, 2014
SOLACE SOUND GENERATORS
K132965
Amplisound Hearing Products & Services
Ear, Nose, Throat · 186d
Cleared Mar 18, 2014
TINNITUS SOUNDSUPPORT
K133308
Oticon A/S
Ear, Nose, Throat · 141d
Cleared Jan 03, 2014
WAVE 2G, SOUL
K130937
Hansaton Akustik GmbH
Ear, Nose, Throat · 274d
Cleared Nov 21, 2013
AUDIFON ARRIVA CIC, IS, IS+, M, S, S+, X TRT, AUDIFON VICO, AUDIFON PRADO, AUDIFON ELIA, CIC, IS, IS+, M, S TRT
K130514
Audifon-USA, Inc.
Ear, Nose, Throat · 267d

About Product Code KLW - Regulatory Context

510(k) Submission Activity

78 total 510(k) submissions under product code KLW since 1977, with 78 receiving FDA clearance (average review time: 114 days).

Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 4 in the prior period.

FDA 510(k) Review Time - KLW Product Code

Recent submissions under KLW have taken an average of 145 days to reach a decision - up from 113 days historically. Manufacturers should account for longer review timelines in current project planning.

KLW devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →