ClearanceBrief
Panels › Ear, Nose, Throat › Product code KLW · Class 2

Masker, Tinnitus

Regulation 874.3400

2510(k)s in 12 months (78 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
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Top companies in KLW

Company510(k)sRecalls
Starkey Laboratories100
Audifon GmbH & Co. KG40
GN Hearing A/S30
Gn Resound A/S30
Siemens Hearing Instruments, Inc.30
Audiotrone20
Marpac, Inc.20
Soundcure, Inc.20
Tinnitus Control, Inc.20
Tinnitus Treatment Centers, Inc.20
Decided510(k)Device and applicantCode
Aug 13, 2026K260413Levo Gen 2 Tinnitus Therapy System
Levo Medical Corporation, CA
KLW
Jun 10, 2026K260614Tinnitus Therapy
Sivantos GmbH, DE
KLW
Feb 27, 2024K233435Peace N Quiet (0.7.0)
Pnq Health
KLW
Jun 30, 2023K223694Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)
Duearity AB, SE
KLW
Feb 1, 2023K221168Tinnitogram Signal Generator
Goldenear Company, Inc.
KLW
Jan 4, 2023K221125SilentCloud
Aureliym GmbH, DE
KLW
Jun 19, 2020K201370Multiflex Tinnitus Technology
Starkey Laboratories, Inc.
KLW
Feb 20, 2020K193303Tinnitus Sound Generator Module
GN Hearing A/S, DK
KLW
Nov 30, 2018K180495Tinnitus Sound Generator Module
GN Hearing A/S, DK
KLW
Jul 13, 2018K181586Tinnitus Sound Generator Module
GN Hearing A/S, DK
KLW
Oct 19, 2017K171243audifon Tinnitus-Module
Audiofon USA, Inc.
KLW
May 17, 2017K163094TinniLogic Mobile Tinnitus Management Device
Jiangsu Betterlife Medical Co., Ltd., CN
KLW
Sep 28, 2016K161562Sound Options Tinnitus Treatment
Sound Options Tinnitus Treatments, Inc., CA
KLW
Aug 23, 2016K161331HyperSound Tinnitus Module
Turtle Beach Corporation
KLW
Jan 20, 2016K151558Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System
Neurotherapies Reset GmbH, DE
KLW
Oct 9, 2015K151719REVE134
Kw Ear Lab, Inc.
KLW
Jul 27, 2015K150014Serenity
Sanuthera, Inc.
KLW
May 14, 2015K150171Tinnitus Sound Generator Module
Gn Resound A/S, DK
KLW
Apr 13, 2015K150065SoundCure Serenade Tinnitus Treatment System
Soundcure, Inc.
KLW
Jul 18, 2014K140845LEVO TINNITUS MASKING SOFTWARE DEVICE
Otoharmonics Corp
KLW
Mar 25, 2014K132965SOLACE SOUND GENERATORS
Amplisound Hearing Products & Services
KLW
Mar 18, 2014K133308TINNITUS SOUNDSUPPORT
Oticon A/S, DK
KLW
Jan 3, 2014K130937WAVE 2G, SOUL
Hansaton Akustik GmbH, DE
KLW
Nov 21, 2013K130514AUDIFON ARRIVA CIC, IS, IS+, M, S, S+, X TRT, AUDIFON VICO, AUDIFON PRADO, AUDIFON ELIA, CIC, IS, IS+, M, S TRT
Audifon-USA, Inc.
KLW
Sep 12, 2013K130417AUDIFON SUENO CIC, AUDIFON SUENO S, AUDIFON SUENO T CIC, AUDIFON SUENO T S
Audifon-USA, Inc.
KLW
May 7, 2013K130494UNITRON TINNITUS MASKER FEATURE
Unitron Hearing
KLW
Feb 11, 2013K123450PHONAK TINNITUS BALANCE
Phonak, LLC
KLW
Oct 31, 2012K122876MULTIFLEX TINNITUS TECHNOLOGY
Starkey Laboratories
KLW
Dec 16, 2011K112752TINNITUS THERAPY SYSTEM ANM T30 CR
Anm Adaptive Neuromodulation GmbH, DE
KLW
Aug 24, 2011K111293SOUNDCURE SERENADE TINNITUS TREATMENT SYSTEM
Soundcure, Inc.
KLW
May 5, 2011K110973IE-ZEN (IN CLEAR SERIES HEARING AID)
Widex USA
KLW
May 3, 2011K110932TINNITUS SOUND GENERATOR MODULE
Gn Resound A/S, DK
KLW
Dec 22, 2010K093715EVOK 900 SERIES HEARING AID/TINNITUS MASKER OPTION DEVICE
Magnatone Hearing Aid Corp. Dba Persona Medical
KLW
Aug 12, 2009K091552SWITCH TRT
Audifon GmbH & Co. KG
KLW
Feb 19, 2009K083488JUMP S+ TRT, JUMP CIC TRT, JUMP S TRT, JUMP C TRT
Audifon-USA, Inc.
KLW
Jun 27, 2008K080955ZEN PROGRAM (MIND 440 HEARING AID)
Widex Hearing Aid Co., Inc.
KLW
Mar 13, 2008K073636TINNITUS SOUND GENERATOR MODULE
Gn Resound A/S, DK
KLW
Jul 13, 2007K070599CUSTOMIZED SOUND THERAPY (CST)
Tinnitus Otosound Products, LLC
KLW
Jun 29, 2007K070648THE INHIBITOR, MODEL 001
Melmedtronics, Inc.
KLW
Jun 30, 2006K061459TRANQUIL TRI-BTE
General Hearing Instruments, Inc.
KLW
May 16, 2006K061111TINNITUS PHASE-OUT
Tinnitus Control, Inc.
KLW
Jan 28, 2005K043274NEUROMONICS TINNITUS TREATMENT
Neuromonics Pty, Ltd., AU
KLW
Jul 1, 2004K041302REFUGE SOUND GENERATOR
Micro-Ear Technology, Inc.
KLW
Apr 12, 2004K040330QUIESCENCE
Spectral Visualization & Development, Inc., CA
KLW
Sep 17, 2003K030180CRESCENT TINNITUS RETAINING SOUND GENERATOR
Starkey Laboratories, Inc.
KLW
Jul 24, 2003K031624TINNITUS RX
Tinnitus Control, Inc.
KLW
Apr 17, 2003K030791ANMP (ACOUSTIC NEURO MODULATION PROTOCOL)
Tinnitech, Ltd., AU
KLW
Jul 13, 2002K021202ULTRAQUIET
Sound Technique System, LLC
KLW
May 21, 2002K013827TST - SUPPRESSOR MODEL #1000
Neurosim Limited, AU
KLW
Apr 5, 2002K013253HISONIC-TRD TINNITUS RELIEF DEVICE
Hearing Innovations, Inc.
KLW

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