Product Code: KLW FDA class 2 21 CFR 874.3400

Masker, Tinnitus

Ear, Nose, Throat

A Tinnitus Masker is an ear, nose, and throat device worn in or around the ear that generates a broad-spectrum or narrowband sound to mask or reduce the perception of tinnitus (ringing or noise in the ears), providing relief for affected patients. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket notification. The product code is KLW and the applicable regulation is 21 CFR 874.3400 in the Ear, Nose, and Throat specialty. This device is eligible for third-party review.

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FEI Numbers

Registration Numbers

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Basic Information

Product Code: KLW
Device Class: FDA class 2
Regulation Number: 874.3400
Medical Specialty: Ear, Nose, Throat
Review Panel: EN
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 77 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K260614	Tinnitus Therapy	Jun 10, 2026	Substantially Equivalent	Sivantos GmbH
K233435	Peace N Quiet (0.7.0)	Feb 27, 2024	Substantially Equivalent	Pnq Health
K223694	Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)	Jun 30, 2023	Substantially Equivalent	Duearity AB
K221168	Tinnitogram Signal Generator	Feb 01, 2023	Substantially Equivalent	Goldenear Company, Inc.
K221125	SilentCloud	Jan 04, 2023	Substantially Equivalent	Aureliym GmbH
K201370	Multiflex Tinnitus Technology	Jun 19, 2020	Substantially Equivalent	Starkey Laboratories, Inc.
K193303	Tinnitus Sound Generator Module	Feb 20, 2020	Substantially Equivalent	GN Hearing A/S
K180495	Tinnitus Sound Generator Module	Nov 30, 2018	Substantially Equivalent	GN Hearing A/S
K181586	Tinnitus Sound Generator Module	Jul 13, 2018	Substantially Equivalent	GN Hearing A/S
K171243	audifon Tinnitus-Module	Oct 19, 2017	Substantially Equivalent	Audiofon USA, Inc.
K163094	TinniLogic Mobile Tinnitus Management Device	May 17, 2017	Substantially Equivalent	Jiangsu Betterlife Medical Co., Ltd.
K161562	Sound Options Tinnitus Treatment	Sep 28, 2016	Substantially Equivalent	Sound Options Tinnitus Treatments, Inc.
K161331	HyperSound Tinnitus Module	Aug 23, 2016	Substantially Equivalent	Turtle Beach Corporation
K151558	Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System	Jan 20, 2016	Substantially Equivalent	Neurotherapies Reset GmbH
K151719	REVE134	Oct 09, 2015	Substantially Equivalent	Kw Ear Lab, Inc.
K150014	Serenity	Jul 27, 2015	Substantially Equivalent	Sanuthera, Inc.
K150171	Tinnitus Sound Generator Module	May 14, 2015	Substantially Equivalent	Gn Resound A/S
K150065	SoundCure Serenade Tinnitus Treatment System	Apr 13, 2015	Substantially Equivalent	Soundcure, Inc.
K140845	LEVO TINNITUS MASKING SOFTWARE DEVICE	Jul 18, 2014	Substantially Equivalent	Otoharmonics Corp
K132965	SOLACE SOUND GENERATORS	Mar 25, 2014	Substantially Equivalent	Amplisound Hearing Products & Services
K133308	TINNITUS SOUNDSUPPORT	Mar 18, 2014	Substantially Equivalent	Oticon A/S
K130937	WAVE 2G, SOUL	Jan 03, 2014	Substantially Equivalent	Hansaton Akustik GmbH
K130514	AUDIFON ARRIVA CIC, IS, IS+, M, S, S+, X TRT, AUDIFON VICO, AUDIFON PRADO, AUDIFON ELIA, CIC, IS, IS+, M, S TRT	Nov 21, 2013	Substantially Equivalent	Audifon-USA, Inc.
K130417	AUDIFON SUENO CIC, AUDIFON SUENO S, AUDIFON SUENO T CIC, AUDIFON SUENO T S	Sep 12, 2013	Substantially Equivalent	Audifon-USA, Inc.
K130494	UNITRON TINNITUS MASKER FEATURE	May 07, 2013	Substantially Equivalent	Unitron Hearing
K123450	PHONAK TINNITUS BALANCE	Feb 11, 2013	Substantially Equivalent	Phonak, LLC
K122876	MULTIFLEX TINNITUS TECHNOLOGY	Oct 31, 2012	Substantially Equivalent	Starkey Laboratories
K112752	TINNITUS THERAPY SYSTEM ANM T30 CR	Dec 16, 2011	Substantially Equivalent	Anm Adaptive Neuromodulation GmbH
K111293	SOUNDCURE SERENADE TINNITUS TREATMENT SYSTEM	Aug 24, 2011	Substantially Equivalent	Soundcure, Inc.
K110973	IE-ZEN (IN CLEAR SERIES HEARING AID)	May 05, 2011	Substantially Equivalent	Widex USA
K110932	TINNITUS SOUND GENERATOR MODULE	May 03, 2011	Substantially Equivalent	Gn Resound A/S
K093715	EVOK 900 SERIES HEARING AID/TINNITUS MASKER OPTION DEVICE	Dec 22, 2010	Substantially Equivalent	Magnatone Hearing Aid Corp. Dba Persona Medical
K091552	SWITCH TRT	Aug 12, 2009	Substantially Equivalent	Audifon GmbH & Co. KG
K083488	JUMP S+ TRT, JUMP CIC TRT, JUMP S TRT, JUMP C TRT	Feb 19, 2009	Substantially Equivalent	Audifon-USA, Inc.
K080955	ZEN PROGRAM (MIND 440 HEARING AID)	Jun 27, 2008	Substantially Equivalent	Widex Hearing Aid Co., Inc.
K073636	TINNITUS SOUND GENERATOR MODULE	Mar 13, 2008	Substantially Equivalent	Gn Resound A/S
K070599	CUSTOMIZED SOUND THERAPY (CST)	Jul 13, 2007	Substantially Equivalent	Tinnitus Otosound Products, LLC
K070648	THE INHIBITOR, MODEL 001	Jun 29, 2007	Substantially Equivalent	Melmedtronics, Inc.
K061459	TRANQUIL TRI-BTE	Jun 30, 2006	Substantially Equivalent	General Hearing Instruments, Inc.
K061111	TINNITUS PHASE-OUT	May 16, 2006	Substantially Equivalent	Tinnitus Control, Inc.
K043274	NEUROMONICS TINNITUS TREATMENT	Jan 28, 2005	Substantially Equivalent	Neuromonics Pty, Ltd.
K041302	REFUGE SOUND GENERATOR	Jul 01, 2004	Substantially Equivalent	Micro-Ear Technology, Inc.
K040330	QUIESCENCE	Apr 12, 2004	Substantially Equivalent	Spectral Visualization & Development, Inc.
K030180	CRESCENT TINNITUS RETAINING SOUND GENERATOR	Sep 17, 2003	Substantially Equivalent	Starkey Laboratories, Inc.
K031624	TINNITUS RX	Jul 24, 2003	Substantially Equivalent	Tinnitus Control, Inc.
K030791	ANMP (ACOUSTIC NEURO MODULATION PROTOCOL)	Apr 17, 2003	Substantially Equivalent	Tinnitech, Ltd.
K021202	ULTRAQUIET	Jul 13, 2002	Substantially Equivalent	Sound Technique System, LLC
K013827	TST - SUPPRESSOR MODEL #1000	May 21, 2002	Substantially Equivalent	Neurosim Limited
K013253	HISONIC-TRD TINNITUS RELIEF DEVICE	Apr 05, 2002	Substantially Equivalent	Hearing Innovations, Inc.
K011364	CUSTOM TCI (TINNITUS CONTROL INSTRUMENT)	Jun 07, 2001	Substantially Equivalent	Siemens Hearing Instruments, Inc.
K011366	CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)	Jun 01, 2001	Substantially Equivalent	Siemens Hearing Instruments, Inc.
K003559	TCI (TINNITUS CONTROL INSTRUMENT)	Apr 26, 2001	Substantially Equivalent	Siemens Hearing Instruments, Inc.
K982451	TTCGHI-T AND TTCTN3-T-T	May 07, 1999	Substantially Equivalent	Tinnitus Treatment Centers, Inc.
K982432	PILLOW MASKER, C2007M, C2008M,CE2000, WONDER EAR, MINI WONDER EAR, PT-2SM, PT-3SM, PT-3LFM, PT-3HFM, PT3CM, PT5-SM, PT5-	Jan 25, 1999	Substantially Equivalent	Tinnitus Treatment Centers, Inc.
K984243	TELEX TINNITUS-COMPANION	Jan 21, 1999	Substantially Equivalent	Telex Communications, Inc.
K981704	AUREX-3	Aug 05, 1998	Substantially Equivalent	Adm Tronics Unltd, Inc.
K974501	DIGITAL TINNITUS MASKING SYSTEM	Jan 20, 1998	Substantially Equivalent	Petroff Audio Technologies
K964216	STARKEY TM-3, TM-5 HIGH FREQUENCY TINNITUS MASKER	Dec 06, 1996	Substantially Equivalent	Starkey Laboratories, Inc.
K963995	STARKEY MA-3 AIR CONDUCTION COMBINATION HEARING AID/TINNITUS MASKER	Nov 26, 1996	Substantially Equivalent	Starkey Laboratories, Inc.
K963838	STARKEY TM AIR CONDUCTION TINNITUS MASKER	Nov 26, 1996	Substantially Equivalent	Starkey Laboratories, Inc.
K941834	AUDITORY CASSETTE	Oct 31, 1994	Substantially Equivalent	Ltmlt, Inc.
K940567	MODEL#1550 MARSONA(R) TINNITUS MASKER	Jul 06, 1994	Substantially Equivalent	Marpac, Inc.
K924991	MICRO MASKER	Jun 14, 1993	Substantially Equivalent	Associated Hearing Instruments
K922572	321Q MINIMUM ENERGY TINNITUS SUPPRESSOR	Nov 02, 1992	Substantially Equivalent	Microbio-Medics, Inc.
K802750	NUVOX BEDSIDE TINNITUS MASKER	Dec 31, 1980	Substantially Equivalent	Hal-Hen Co., Inc.
K802234	BEDSIDE TINNITUS MASKER #1500	Oct 10, 1980	Substantially Equivalent	Marpac, Inc.
K800702	TA-641 TINNITUS INSTRUMENT	May 08, 1980	Substantially Equivalent	Audiotrone
K800784	MINUET MASKER; JUBILEE MASKER	Apr 29, 1980	Substantially Equivalent	Beltone Electronics Corp.
K800701	T-570 TINNITUS MASKER	Apr 10, 1980	Substantially Equivalent	Audiotrone
K791790	MODEL TM5 BEHIND EAR TINNITUS MASKER	Oct 26, 1979	Substantially Equivalent	Starkey Laboratories, Inc.
K791142	HEARING AID, MODEL MA-1	Sep 28, 1979	Substantially Equivalent	Starkey Laboratories, Inc.
K791071	MODEL MA3 BEHIND-THE-EAR MASKER/HEARING	Jul 03, 1979	Substantially Equivalent	Starkey Laboratories, Inc.
K790190	TINNITUS MASKERS MODEL S584	Feb 12, 1979	Substantially Equivalent	Vican Instrument Co.
K781798	TINNITUS MASKER	Nov 03, 1978	Substantially Equivalent	Starkey Laboratories, Inc.
K780546	BEHIND-THE-EAR MASKING AMPLIFIER,735S	Apr 10, 1978	Substantially Equivalent	Danavox, Inc.
K771769	TINNITUS MASKERS, MODELS S564&S574	Jan 03, 1978	Substantially Equivalent	Vicon Instrument Co.
K770938	TINNITUS AID, MODEL S244	Jun 28, 1977	Substantially Equivalent	Vicon Instrument Co.