FDA 510(k) Applications for Medical Device Product Code "KLW"
(Masker, Tinnitus)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K981704 | ADM TRONICS UNLTD, INC. | AUREX-3 | 08/05/1998 |
| K132965 | AMPLISOUND HEARING PRODUCTS & SERVICES | SOLACE SOUND GENERATORS | 03/25/2014 |
| K112752 | ANM ADAPTIVE NEUROMODULATION GMBH | TINNITUS THERAPY SYSTEM ANM T30 CR | 12/16/2011 |
| K091552 | AUDIFON GMBH & CO. KG | SWITCH TRT | 08/12/2009 |
| K130514 | AUDIFON-USA INC. | AUDIFON ARRIVA CIC, IS, IS+, M, S, S+, X TRT, AUDIFON VICO, AUDIFON PRADO, AUDIFON ELIA, CIC, IS, IS+, M, S TRT | 11/21/2013 |
| K130417 | AUDIFON-USA INC. | AUDIFON SUENO CIC, AUDIFON SUENO S, AUDIFON SUENO T CIC, AUDIFON SUENO T S | 09/12/2013 |
| K083488 | AUDIFON-USA INC. | JUMP S+ TRT, JUMP CIC TRT, JUMP S TRT, JUMP C TRT | 02/19/2009 |
| K171243 | audiofon USA Inc. | audifon Tinnitus-Module | 10/19/2017 |
| K221125 | Aureliym GmBH | SilentCloud | 01/04/2023 |
| K223694 | Duearity AB | Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042) | 06/30/2023 |
| K061459 | GENERAL HEARING INSTRUMENTS, INC. | TRANQUIL TRI-BTE | 06/30/2006 |
| K180495 | GN Hearing A/S | Tinnitus Sound Generator Module | 11/30/2018 |
| K181586 | GN Hearing A/S | Tinnitus Sound Generator Module | 07/13/2018 |
| K193303 | GN Hearing A/S | Tinnitus Sound Generator Module | 02/20/2020 |
| K110932 | GN RESOUND A/S | TINNITUS SOUND GENERATOR MODULE | 05/03/2011 |
| K073636 | GN RESOUND A/S | TINNITUS SOUND GENERATOR MODULE | 03/13/2008 |
| K150171 | GN RESOUND A/S | Tinnitus Sound Generator Module | 05/14/2015 |
| K221168 | Goldenear Company, Inc. | Tinnitogram Signal Generator | 02/01/2023 |
| K130937 | HANSATON AKUSTIK GMBH | WAVE 2G, SOUL | 01/03/2014 |
| K013253 | HEARING INNOVATIONS, INC. | HISONIC-TRD TINNITUS RELIEF DEVICE | 04/05/2002 |
| K163094 | JIANGSU BETTERLIFE MEDICAL CO., LTD. | TinniLogic Mobile Tinnitus Management Device | 05/17/2017 |
| K151719 | KW EAR LAB, INC | REVE134 | 10/09/2015 |
| K093715 | MAGNATONE HEARING AID CORP. DBA PERSONA MEDICAL | EVOK 900 SERIES HEARING AID/TINNITUS MASKER OPTION DEVICE | 12/22/2010 |
| K070648 | MELMEDTRONICS, INC. | THE INHIBITOR, MODEL 001 | 06/29/2007 |
| K041302 | MICRO-EAR TECHNOLOGY, INC. | REFUGE SOUND GENERATOR | 07/01/2004 |
| K043274 | NEUROMONICS PTY LTD | NEUROMONICS TINNITUS TREATMENT | 01/28/2005 |
| K013827 | NEUROSIM LIMITED | TST - SUPPRESSOR MODEL #1000 | 05/21/2002 |
| K151558 | NEUROTHERAPIES RESET GMBH. | Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System | 01/20/2016 |
| K133308 | OTICON A/S | TINNITUS SOUNDSUPPORT | 03/18/2014 |
| K140845 | OTOHARMONICS CORP | LEVO TINNITUS MASKING SOFTWARE DEVICE | 07/18/2014 |
| K974501 | PETROFF AUDIO TECHNOLOGIES | DIGITAL TINNITUS MASKING SYSTEM | 01/20/1998 |
| K123450 | PHONAK LLC | PHONAK TINNITUS BALANCE | 02/11/2013 |
| K150014 | SANUTHERA, INC. | Serenity | 07/27/2015 |
| K011364 | SIEMENS HEARING INSTRUMENTS, INC. | CUSTOM TCI (TINNITUS CONTROL INSTRUMENT) | 06/07/2001 |
| K011366 | SIEMENS HEARING INSTRUMENTS, INC. | CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) | 06/01/2001 |
| K003559 | SIEMENS HEARING INSTRUMENTS, INC. | TCI (TINNITUS CONTROL INSTRUMENT) | 04/26/2001 |
| K161562 | Sound Options Tinnitus Treatments Inc. | Sound Options Tinnitus Treatment | 09/28/2016 |
| K021202 | SOUND TECHNIQUE SYSTEM, LLC | ULTRAQUIET | 07/13/2002 |
| K111293 | SOUNDCURE INC | SOUNDCURE SERENADE TINNITUS TREATMENT SYSTEM | 08/24/2011 |
| K150065 | SoundCure, Inc. | SoundCure Serenade Tinnitus Treatment System | 04/13/2015 |
| K040330 | SPECTRAL VISUALIZATION & DEVELOPMENT, INC. | QUIESCENCE | 04/12/2004 |
| K122876 | STARKEY LABORATORIES | MULTIFLEX TINNITUS TECHNOLOGY | 10/31/2012 |
| K030180 | STARKEY LABORATORIES, INC. | CRESCENT TINNITUS RETAINING SOUND GENERATOR | 09/17/2003 |
| K201370 | Starkey Laboratories, Inc. | Multiflex Tinnitus Technology | 06/19/2020 |
| K963995 | STARKEY LABORATORIES, INC. | STARKEY MA-3 AIR CONDUCTION COMBINATION HEARING AID/TINNITUS MASKER | 11/26/1996 |
| K963838 | STARKEY LABORATORIES, INC. | STARKEY TM AIR CONDUCTION TINNITUS MASKER | 11/26/1996 |
| K964216 | STARKEY LABORATORIES, INC. | STARKEY TM-3, TM-5 HIGH FREQUENCY TINNITUS MASKER | 12/06/1996 |
| K984243 | TELEX COMMUNICATIONS, INC. | TELEX TINNITUS-COMPANION | 01/21/1999 |
| K030791 | TINNITECH LTD | ANMP (ACOUSTIC NEURO MODULATION PROTOCOL) | 04/17/2003 |
| K061111 | TINNITUS CONTROL, INC. | TINNITUS PHASE-OUT | 05/16/2006 |
| K031624 | TINNITUS CONTROL, INC. | TINNITUS RX | 07/24/2003 |
| K070599 | TINNITUS OTOSOUND PRODUCTS, LLC | CUSTOMIZED SOUND THERAPY (CST) | 07/13/2007 |
| K982432 | TINNITUS TREATMENT CENTERS, INC. | PILLOW MASKER, C2007M, C2008M,CE2000, WONDER EAR, MINI WONDER EAR, PT-2SM, PT-3SM, PT-3LFM, PT-3HFM, PT3CM, PT5-SM, PT5- | 01/25/1999 |
| K982451 | TINNITUS TREATMENT CENTERS, INC. | TTCGHI-T AND TTCTN3-T-T | 05/07/1999 |
| K161331 | TURTLE BEACH CORPORATION | HyperSound Tinnitus Module | 08/23/2016 |
| K130494 | UNITRON HEARING | UNITRON TINNITUS MASKER FEATURE | 05/07/2013 |
| K080955 | WIDEX HEARING AID CO., INC. | ZEN PROGRAM (MIND 440 HEARING AID) | 06/27/2008 |
| K110973 | WIDEX USA | IE-ZEN (IN CLEAR SERIES HEARING AID) | 05/05/2011 |
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