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Masker, Tinnitus

FDA product code KLW · 70 cleared devices

Class 2 Ear, Nose, Throat

Regulation: 21 CFR 874.3400
Review panel: EN
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-06-28 – 2026-08-13

KLW 2026-08-13

Levo Gen 2 Tinnitus Therapy System

Applicant Levo Medical Corporation

K number K260413

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KLW 2026-06-10

Tinnitus Therapy

Applicant Sivantos GmbH

K number K260614

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KLW 2024-02-27

Peace N Quiet (0.7.0)

Applicant Pnq Health

K number K233435

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KLW 2023-06-30

Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)

Applicant Duearity AB

K number K223694

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KLW 2023-02-01

Tinnitogram Signal Generator

Applicant Goldenear Company, Inc.

K number K221168

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KLW 2023-01-04

SilentCloud

Applicant Aureliym GmbH

K number K221125

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KLW 2020-06-19

Multiflex Tinnitus Technology

Applicant Starkey Laboratories, Inc.

K number K201370

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KLW 2020-02-20

Tinnitus Sound Generator Module

Applicant GN Hearing A/S

K number K193303

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KLW 2018-11-30

Tinnitus Sound Generator Module

Applicant GN Hearing A/S

K number K180495

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KLW 2018-07-13

Tinnitus Sound Generator Module

Applicant GN Hearing A/S

K number K181586

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KLW 2017-10-19

audifon Tinnitus-Module

Applicant Audiofon USA, Inc.

K number K171243

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KLW 2017-05-17

TinniLogic Mobile Tinnitus Management Device

Applicant Jiangsu Betterlife Medical Co., Ltd.

K number K163094

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KLW 2016-09-28

Sound Options Tinnitus Treatment

Applicant Sound Options Tinnitus Treatments, Inc.

K number K161562

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KLW 2016-08-23

HyperSound Tinnitus Module

Applicant Turtle Beach Corporation

K number K161331

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KLW 2016-01-20

Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System

Applicant Neurotherapies Reset GmbH

K number K151558

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KLW 2013-11-21

AUDIFON ARRIVA CIC, IS, IS+, M, S, S+, X TRT, AUDIFON VICO, AUDIFON PRADO, AUDIFON ELIA, CIC, IS, IS+, M, S TRT

Applicant Audifon-USA, Inc.

K number K130514

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KLW 2013-09-12

AUDIFON SUENO CIC, AUDIFON SUENO S, AUDIFON SUENO T CIC, AUDIFON SUENO T S

Applicant Audifon-USA, Inc.

K number K130417

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KLW 2013-05-07

UNITRON TINNITUS MASKER FEATURE

Applicant Unitron Hearing

K number K130494

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KLW 2013-02-11

PHONAK TINNITUS BALANCE

Applicant Phonak, LLC

K number K123450

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KLW 2012-10-31

MULTIFLEX TINNITUS TECHNOLOGY

Applicant Starkey Laboratories

K number K122876

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KLW 2011-12-16

TINNITUS THERAPY SYSTEM ANM T30 CR

Applicant Anm Adaptive Neuromodulation GmbH

K number K112752

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KLW 2011-08-24

SOUNDCURE SERENADE TINNITUS TREATMENT SYSTEM

Applicant Soundcure, Inc.

K number K111293

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KLW 2011-05-05

IE-ZEN (IN CLEAR SERIES HEARING AID)

Applicant Widex USA

K number K110973

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KLW 2011-05-03

TINNITUS SOUND GENERATOR MODULE

Applicant Gn Resound A/S

K number K110932

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KLW 2010-12-22

EVOK 900 SERIES HEARING AID/TINNITUS MASKER OPTION DEVICE

Applicant Magnatone Hearing Aid Corp. Dba Persona Medical

K number K093715

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KLW 2009-08-12

SWITCH TRT

Applicant Audifon GmbH & Co. KG

K number K091552

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KLW 2009-02-19

JUMP S+ TRT, JUMP CIC TRT, JUMP S TRT, JUMP C TRT

Applicant Audifon-USA, Inc.

K number K083488

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KLW 2008-06-27

ZEN PROGRAM (MIND 440 HEARING AID)

Applicant Widex Hearing Aid Co., Inc.

K number K080955

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KLW 2008-03-13

TINNITUS SOUND GENERATOR MODULE

Applicant Gn Resound A/S

K number K073636

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KLW 2007-07-13

CUSTOMIZED SOUND THERAPY (CST)

Applicant Tinnitus Otosound Products, LLC

K number K070599

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KLW 2007-06-29

THE INHIBITOR, MODEL 001

Applicant Melmedtronics, Inc.

K number K070648

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KLW 2006-06-30

TRANQUIL TRI-BTE

Applicant General Hearing Instruments, Inc.

K number K061459

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KLW 2006-05-16

TINNITUS PHASE-OUT

Applicant Tinnitus Control, Inc.

K number K061111

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KLW 2005-01-28

NEUROMONICS TINNITUS TREATMENT

Applicant Neuromonics Pty, Ltd.

K number K043274

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KLW 2004-07-01

REFUGE SOUND GENERATOR

Applicant Micro-Ear Technology, Inc.

K number K041302

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KLW 2004-04-12

QUIESCENCE

Applicant Spectral Visualization & Development, Inc.

K number K040330

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KLW 2003-09-17

CRESCENT TINNITUS RETAINING SOUND GENERATOR

Applicant Starkey Laboratories, Inc.

K number K030180

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KLW 2003-07-24

TINNITUS RX

Applicant Tinnitus Control, Inc.

K number K031624

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KLW 2003-04-17

ANMP (ACOUSTIC NEURO MODULATION PROTOCOL)

Applicant Tinnitech, Ltd.

K number K030791

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KLW 2002-07-13

ULTRAQUIET

Applicant Sound Technique System, LLC

K number K021202

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KLW 2002-05-21

TST - SUPPRESSOR MODEL #1000

Applicant Neurosim Limited

K number K013827

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KLW 2002-04-05

HISONIC-TRD TINNITUS RELIEF DEVICE

Applicant Hearing Innovations, Inc.

K number K013253

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KLW 2001-06-07

CUSTOM TCI (TINNITUS CONTROL INSTRUMENT)

Applicant Siemens Hearing Instruments, Inc.

K number K011364

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KLW 2001-06-01

CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)

Applicant Siemens Hearing Instruments, Inc.

K number K011366

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KLW 2001-04-26

TCI (TINNITUS CONTROL INSTRUMENT)

Applicant Siemens Hearing Instruments, Inc.

K number K003559

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KLW 1999-05-07

TTCGHI-T AND TTCTN3-T-T

Applicant Tinnitus Treatment Centers, Inc.

K number K982451

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KLW 1999-01-25

PILLOW MASKER, C2007M, C2008M,CE2000, WONDER EAR, MINI WONDER EAR, PT-2SM, PT-3SM, PT-3LFM, PT-3HFM, PT3CM, PT5-SM, PT5-

Applicant Tinnitus Treatment Centers, Inc.

K number K982432

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KLW 1999-01-21

TELEX TINNITUS-COMPANION

Applicant Telex Communications, Inc.

K number K984243

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KLW 1998-08-05

AUREX-3

Applicant Adm Tronics Unltd, Inc.

K number K981704

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KLW 1998-01-20

DIGITAL TINNITUS MASKING SYSTEM

Applicant Petroff Audio Technologies

K number K974501

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KLW 1996-12-06

STARKEY TM-3, TM-5 HIGH FREQUENCY TINNITUS MASKER

Applicant Starkey Laboratories, Inc.

K number K964216

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KLW 1996-11-26

STARKEY MA-3 AIR CONDUCTION COMBINATION HEARING AID/TINNITUS MASKER

Applicant Starkey Laboratories, Inc.

K number K963995

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KLW 1996-11-26

STARKEY TM AIR CONDUCTION TINNITUS MASKER

Applicant Starkey Laboratories, Inc.

K number K963838

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KLW 1994-10-31

AUDITORY CASSETTE

Applicant Ltmlt, Inc.

K number K941834

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KLW 1994-07-06

MODEL#1550 MARSONA(R) TINNITUS MASKER

Applicant Marpac, Inc.

K number K940567

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KLW 1993-06-14

MICRO MASKER

Applicant Associated Hearing Instruments

K number K924991

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KLW 1992-11-02

321Q MINIMUM ENERGY TINNITUS SUPPRESSOR

Applicant Microbio-Medics, Inc.

K number K922572

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KLW 1980-12-31

NUVOX BEDSIDE TINNITUS MASKER

Applicant Hal-Hen Co., Inc.

K number K802750

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KLW 1980-10-10

BEDSIDE TINNITUS MASKER #1500

Applicant Marpac, Inc.

K number K802234

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KLW 1980-05-08

TA-641 TINNITUS INSTRUMENT

Applicant Audiotrone

K number K800702

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KLW 1980-04-29

MINUET MASKER; JUBILEE MASKER

Applicant Beltone Electronics Corp.

K number K800784

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KLW 1980-04-10

T-570 TINNITUS MASKER

Applicant Audiotrone

K number K800701

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KLW 1979-10-26

MODEL TM5 BEHIND EAR TINNITUS MASKER

Applicant Starkey Laboratories, Inc.

K number K791790

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KLW 1979-09-28

HEARING AID, MODEL MA-1

Applicant Starkey Laboratories, Inc.

K number K791142

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KLW 1979-07-03

MODEL MA3 BEHIND-THE-EAR MASKER/HEARING

Applicant Starkey Laboratories, Inc.

K number K791071

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KLW 1979-02-12

TINNITUS MASKERS MODEL S584

Applicant Vican Instrument Co.

K number K790190

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KLW 1978-11-03

TINNITUS MASKER

Applicant Starkey Laboratories, Inc.

K number K781798

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KLW 1978-04-10

BEHIND-THE-EAR MASKING AMPLIFIER,735S

Applicant Danavox, Inc.

K number K780546

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KLW 1978-01-03

TINNITUS MASKERS, MODELS S564&S574

Applicant Vicon Instrument Co.

K number K771769

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KLW 1977-06-28

TINNITUS AID, MODEL S244

Applicant Vicon Instrument Co.

K number K770938

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