Atlas FDA

KLW

77 FDA 510(k) clearances · Product code

88 daysmedian time to decision
256 days90th percentile
77clearances measured

FDA profile

Official device name
Masker, Tinnitus
Device class
Class II (moderate risk)
Regulation
21 CFR 874.3400
Medical specialty
Ear, Nose, Throat
Flags
Third-party review eligible
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RecordFirmDate
Tinnitus Therapy (K260614)Sivantos GmbH2026-06-10
Peace N Quiet (0.7.0) (K233435)Pnq Health2024-02-27
Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042) (K223694)Duearity AB2023-06-30
Tinnitogram Signal Generator (K221168)Goldenear Company, Inc.2023-02-01
SilentCloud (K221125)Aureliym GmbH2023-01-04
Multiflex Tinnitus Technology (K201370)Starkey Laboratories, Inc.2020-06-19
Tinnitus Sound Generator Module (K193303)GN Hearing A/S2020-02-20
Tinnitus Sound Generator Module (K180495)GN Hearing A/S2018-11-30
Tinnitus Sound Generator Module (K181586)GN Hearing A/S2018-07-13
audifon Tinnitus-Module (K171243)Audiofon USA, Inc.2017-10-19
TinniLogic Mobile Tinnitus Management Device (K163094)Jiangsu Betterlife Medical Co., Ltd.2017-05-17
Sound Options Tinnitus Treatment (K161562)Sound Options Tinnitus Treatments, Inc.2016-09-28
HyperSound Tinnitus Module (K161331)Turtle Beach Corporation2016-08-23
Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System (K151558)Neurotherapies Reset GmbH2016-01-20
REVE134 (K151719)Kw Ear Lab, Inc.2015-10-09
Serenity (K150014)Sanuthera, Inc.2015-07-27
Tinnitus Sound Generator Module (K150171)Gn Resound A/S2015-05-14
SoundCure Serenade Tinnitus Treatment System (K150065)Soundcure, Inc.2015-04-13
LEVO TINNITUS MASKING SOFTWARE DEVICE (K140845)Otoharmonics Corp2014-07-18
SOLACE SOUND GENERATORS (K132965)Amplisound Hearing Products & Services2014-03-25
TINNITUS SOUNDSUPPORT (K133308)Oticon A/S2014-03-18
WAVE 2G, SOUL (K130937)Hansaton Akustik GmbH2014-01-03
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.2013-11-21
AUDIFON SUENO CIC, AUDIFON SUENO S, AUDIFON SUENO T CIC, AUDIFON SUENO T S (K130417)Audifon-USA, Inc.2013-09-12
UNITRON TINNITUS MASKER FEATURE (K130494)Unitron Hearing2013-05-07
PHONAK TINNITUS BALANCE (K123450)Phonak, LLC2013-02-11
MULTIFLEX TINNITUS TECHNOLOGY (K122876)Starkey Laboratories2012-10-31
TINNITUS THERAPY SYSTEM ANM T30 CR (K112752)Anm Adaptive Neuromodulation GmbH2011-12-16
SOUNDCURE SERENADE TINNITUS TREATMENT SYSTEM (K111293)Soundcure, Inc.2011-08-24
IE-ZEN (IN CLEAR SERIES HEARING AID) (K110973)Widex USA2011-05-05
TINNITUS SOUND GENERATOR MODULE (K110932)Gn Resound A/S2011-05-03
EVOK 900 SERIES HEARING AID/TINNITUS MASKER OPTION DEVICE (K093715)Magnatone Hearing Aid Corp. Dba Persona Medical2010-12-22
SWITCH TRT (K091552)Audifon GmbH & Co. KG2009-08-12
JUMP S+ TRT, JUMP CIC TRT, JUMP S TRT, JUMP C TRT (K083488)Audifon-USA, Inc.2009-02-19
ZEN PROGRAM (MIND 440 HEARING AID) (K080955)Widex Hearing Aid Co., Inc.2008-06-27
TINNITUS SOUND GENERATOR MODULE (K073636)Gn Resound A/S2008-03-13
CUSTOMIZED SOUND THERAPY (CST) (K070599)Tinnitus Otosound Products, LLC2007-07-13
THE INHIBITOR, MODEL 001 (K070648)Melmedtronics, Inc.2007-06-29
TRANQUIL TRI-BTE (K061459)General Hearing Instruments, Inc.2006-06-30
TINNITUS PHASE-OUT (K061111)Tinnitus Control, Inc.2006-05-16
NEUROMONICS TINNITUS TREATMENT (K043274)Neuromonics Pty, Ltd.2005-01-28
REFUGE SOUND GENERATOR (K041302)Micro-Ear Technology, Inc.2004-07-01
QUIESCENCE (K040330)Spectral Visualization & Development, Inc.2004-04-12
CRESCENT TINNITUS RETAINING SOUND GENERATOR (K030180)Starkey Laboratories, Inc.2003-09-17
TINNITUS RX (K031624)Tinnitus Control, Inc.2003-07-24
ANMP (ACOUSTIC NEURO MODULATION PROTOCOL) (K030791)Tinnitech, Ltd.2003-04-17
ULTRAQUIET (K021202)Sound Technique System, LLC2002-07-13
TST - SUPPRESSOR MODEL #1000 (K013827)Neurosim Limited2002-05-21
HISONIC-TRD TINNITUS RELIEF DEVICE (K013253)Hearing Innovations, Inc.2002-04-05
CUSTOM TCI (TINNITUS CONTROL INSTRUMENT) (K011364)Siemens Hearing Instruments, Inc.2001-06-07
CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) (K011366)Siemens Hearing Instruments, Inc.2001-06-01
TCI (TINNITUS CONTROL INSTRUMENT) (K003559)Siemens Hearing Instruments, Inc.2001-04-26
TTCGHI-T AND TTCTN3-T-T (K982451)Tinnitus Treatment Centers, Inc.1999-05-07
PILLOW MASKER, C2007M, C2008M,CE2000, WONDER EAR, MINI WONDER EAR, PT-2SM, PT-3SM, PT-3LFM, PT-3HFM, PT3CM, PT5-SM, PT5- (K982432)Tinnitus Treatment Centers, Inc.1999-01-25
TELEX TINNITUS-COMPANION (K984243)Telex Communications, Inc.1999-01-21
AUREX-3 (K981704)Adm Tronics Unltd, Inc.1998-08-05
DIGITAL TINNITUS MASKING SYSTEM (K974501)Petroff Audio Technologies1998-01-20
STARKEY TM-3, TM-5 HIGH FREQUENCY TINNITUS MASKER (K964216)Starkey Laboratories, Inc.1996-12-06
STARKEY MA-3 AIR CONDUCTION COMBINATION HEARING AID/TINNITUS MASKER (K963995)Starkey Laboratories, Inc.1996-11-26
STARKEY TM AIR CONDUCTION TINNITUS MASKER (K963838)Starkey Laboratories, Inc.1996-11-26
AUDITORY CASSETTE (K941834)Ltmlt, Inc.1994-10-31
MODEL#1550 MARSONA(R) TINNITUS MASKER (K940567)Marpac, Inc.1994-07-06
MICRO MASKER (K924991)Associated Hearing Instruments1993-06-14
321Q MINIMUM ENERGY TINNITUS SUPPRESSOR (K922572)Microbio-Medics, Inc.1992-11-02
NUVOX BEDSIDE TINNITUS MASKER (K802750)Hal-Hen Co., Inc.1980-12-31
BEDSIDE TINNITUS MASKER #1500 (K802234)Marpac, Inc.1980-10-10
TA-641 TINNITUS INSTRUMENT (K800702)Audiotrone1980-05-08
MINUET MASKER; JUBILEE MASKER (K800784)Beltone Electronics Corp.1980-04-29
T-570 TINNITUS MASKER (K800701)Audiotrone1980-04-10
MODEL TM5 BEHIND EAR TINNITUS MASKER (K791790)Starkey Laboratories, Inc.1979-10-26
HEARING AID, MODEL MA-1 (K791142)Starkey Laboratories, Inc.1979-09-28
MODEL MA3 BEHIND-THE-EAR MASKER/HEARING (K791071)Starkey Laboratories, Inc.1979-07-03
TINNITUS MASKERS MODEL S584 (K790190)Vican Instrument Co.1979-02-12
TINNITUS MASKER (K781798)Starkey Laboratories, Inc.1978-11-03
BEHIND-THE-EAR MASKING AMPLIFIER,735S (K780546)Danavox, Inc.1978-04-10
TINNITUS MASKERS, MODELS S564&S574 (K771769)Vicon Instrument Co.1978-01-03
TINNITUS AID, MODEL S244 (K770938)Vicon Instrument Co.1977-06-28

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Every clearance here is in the API, with alerts when new ones post.