FDA Product Code
FDA Product Code KLW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ear, Nose, Throat
- 21 CFR Citation
- 874.3400
510(k) Clearances — 78 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260413 | Levo Gen 2 Tinnitus Therapy System | Levo Medical Corporation | 2026-08-13 | Traditional | PDF ↗ |
| K260614 | Tinnitus Therapy | Sivantos GmbH | 2026-06-10 | Special | PDF ↗ |
| K233435 | Peace N Quiet (0.7.0) | Pnq Health | 2024-02-27 | Traditional | PDF ↗ |
| K223694 | Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042) | Duearity AB | 2023-06-30 | Traditional | PDF ↗ |
| K221168 | Tinnitogram Signal Generator | Goldenear Company, Inc. | 2023-02-01 | Traditional | PDF ↗ |
| K221125 | SilentCloud | Aureliym GmbH | 2023-01-04 | Traditional | PDF ↗ |
| K201370 | Multiflex Tinnitus Technology | Starkey Laboratories, Inc. | 2020-06-19 | Special | PDF ↗ |
| K193303 | Tinnitus Sound Generator Module | GN Hearing A/S | 2020-02-20 | Special | PDF ↗ |
| K180495 | Tinnitus Sound Generator Module | GN Hearing A/S | 2018-11-30 | Traditional | PDF ↗ |
| K181586 | Tinnitus Sound Generator Module | GN Hearing A/S | 2018-07-13 | Special | PDF ↗ |
| K171243 | audifon Tinnitus-Module | Audiofon USA, Inc. | 2017-10-19 | Abbreviated | PDF ↗ |
| K163094 | TinniLogic Mobile Tinnitus Management Device | Jiangsu Betterlife Medical Co., Ltd. | 2017-05-17 | Traditional | PDF ↗ |
| K161562 | Sound Options Tinnitus Treatment | Sound Options Tinnitus Treatments, Inc. | 2016-09-28 | Traditional | PDF ↗ |
| K161331 | HyperSound Tinnitus Module | Turtle Beach Corporation | 2016-08-23 | Traditional | PDF ↗ |
| K151558 | Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System | Neurotherapies Reset GmbH | 2016-01-20 | Traditional | PDF ↗ |
| K151719 | REVE134 | Kw Ear Lab, Inc. | 2015-10-09 | Traditional | PDF ↗ |
| K150014 | Serenity | Sanuthera, Inc. | 2015-07-27 | Traditional | PDF ↗ |
| K150171 | Tinnitus Sound Generator Module | Gn Resound A/S | 2015-05-14 | Special | PDF ↗ |
| K150065 | SoundCure Serenade Tinnitus Treatment System | Soundcure, Inc. | 2015-04-13 | Traditional | PDF ↗ |
| K140845 | LEVO TINNITUS MASKING SOFTWARE DEVICE | Otoharmonics Corp | 2014-07-18 | Traditional | PDF ↗ |
| K132965 | SOLACE SOUND GENERATORS | Amplisound Hearing Products & Services | 2014-03-25 | Abbreviated | PDF ↗ |
| K133308 | TINNITUS SOUNDSUPPORT | Oticon A/S | 2014-03-18 | Traditional | PDF ↗ |
| K130937 | WAVE 2G, SOUL | Hansaton Akustik GmbH | 2014-01-03 | Traditional | PDF ↗ |
| K130514 | AUDIFON ARRIVA CIC, IS, IS+, M, S, S+, X TRT, AUDIFON VICO, AUDIFON PRADO, AUDIFON ELIA, CIC, IS, IS+, M, S TRT | Audifon-USA, Inc. | 2013-11-21 | Abbreviated | PDF ↗ |
| K130417 | AUDIFON SUENO CIC, AUDIFON SUENO S, AUDIFON SUENO T CIC, AUDIFON SUENO T S | Audifon-USA, Inc. | 2013-09-12 | Abbreviated | PDF ↗ |
| K130494 | UNITRON TINNITUS MASKER FEATURE | Unitron Hearing | 2013-05-07 | Abbreviated | PDF ↗ |
| K123450 | PHONAK TINNITUS BALANCE | Phonak, LLC | 2013-02-11 | Abbreviated | PDF ↗ |
| K122876 | MULTIFLEX TINNITUS TECHNOLOGY | Starkey Laboratories | 2012-10-31 | Traditional | PDF ↗ |
| K112752 | TINNITUS THERAPY SYSTEM ANM T30 CR | Anm Adaptive Neuromodulation GmbH | 2011-12-16 | Traditional | PDF ↗ |
| K111293 | SOUNDCURE SERENADE TINNITUS TREATMENT SYSTEM | Soundcure, Inc. | 2011-08-24 | Traditional | PDF ↗ |
| K110973 | IE-ZEN (IN CLEAR SERIES HEARING AID) | Widex USA | 2011-05-05 | Special | PDF ↗ |
| K110932 | TINNITUS SOUND GENERATOR MODULE | Gn Resound A/S | 2011-05-03 | Special | PDF ↗ |
| K093715 | EVOK 900 SERIES HEARING AID/TINNITUS MASKER OPTION DEVICE | Magnatone Hearing Aid Corp. Dba Persona Medical | 2010-12-22 | Abbreviated | PDF ↗ |
| K091552 | SWITCH TRT | Audifon GmbH & Co. KG | 2009-08-12 | Abbreviated | PDF ↗ |
| K083488 | JUMP S+ TRT, JUMP CIC TRT, JUMP S TRT, JUMP C TRT | Audifon-USA, Inc. | 2009-02-19 | Abbreviated | PDF ↗ |
| K080955 | ZEN PROGRAM (MIND 440 HEARING AID) | Widex Hearing Aid Co., Inc. | 2008-06-27 | Traditional | PDF ↗ |
| K073636 | TINNITUS SOUND GENERATOR MODULE | Gn Resound A/S | 2008-03-13 | Traditional | PDF ↗ |
| K070599 | CUSTOMIZED SOUND THERAPY (CST) | Tinnitus Otosound Products, LLC | 2007-07-13 | Abbreviated | PDF ↗ |
| K070648 | THE INHIBITOR, MODEL 001 | Melmedtronics, Inc. | 2007-06-29 | Traditional | PDF ↗ |
| K061459 | TRANQUIL TRI-BTE | General Hearing Instruments, Inc. | 2006-06-30 | Special | PDF ↗ |
| K061111 | TINNITUS PHASE-OUT | Tinnitus Control, Inc. | 2006-05-16 | Special | PDF ↗ |
| K043274 | NEUROMONICS TINNITUS TREATMENT | Neuromonics Pty, Ltd. | 2005-01-28 | Traditional | PDF ↗ |
| K041302 | REFUGE SOUND GENERATOR | Micro-Ear Technology, Inc. | 2004-07-01 | Traditional | PDF ↗ |
| K040330 | QUIESCENCE | Spectral Visualization & Development, Inc. | 2004-04-12 | Traditional | PDF ↗ |
| K030180 | CRESCENT TINNITUS RETAINING SOUND GENERATOR | Starkey Laboratories, Inc. | 2003-09-17 | Traditional | PDF ↗ |
| K031624 | TINNITUS RX | Tinnitus Control, Inc. | 2003-07-24 | Traditional | PDF ↗ |
| K030791 | ANMP (ACOUSTIC NEURO MODULATION PROTOCOL) | Tinnitech, Ltd. | 2003-04-17 | Traditional | PDF ↗ |
| K021202 | ULTRAQUIET | Sound Technique System, LLC | 2002-07-13 | Traditional | PDF ↗ |
| K013827 | TST - SUPPRESSOR MODEL #1000 | Neurosim Limited | 2002-05-21 | Traditional | PDF ↗ |
| K013253 | HISONIC-TRD TINNITUS RELIEF DEVICE | Hearing Innovations, Inc. | 2002-04-05 | Traditional | PDF ↗ |
| K011364 | CUSTOM TCI (TINNITUS CONTROL INSTRUMENT) | Siemens Hearing Instruments, Inc. | 2001-06-07 | Traditional | PDF ↗ |
| K011366 | CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) | Siemens Hearing Instruments, Inc. | 2001-06-01 | Traditional | PDF ↗ |
| K003559 | TCI (TINNITUS CONTROL INSTRUMENT) | Siemens Hearing Instruments, Inc. | 2001-04-26 | Traditional | PDF ↗ |
| K982451 | TTCGHI-T AND TTCTN3-T-T | Tinnitus Treatment Centers, Inc. | 1999-05-07 | Traditional | PDF ↗ |
| K982432 | PILLOW MASKER, C2007M, C2008M,CE2000, WONDER EAR, MINI WONDER EAR, PT-2SM, PT-3SM, PT-3LFM, PT-3HFM, PT3CM, PT5-SM, PT5- | Tinnitus Treatment Centers, Inc. | 1999-01-25 | Traditional | PDF ↗ |
| K984243 | TELEX TINNITUS-COMPANION | Telex Communications, Inc. | 1999-01-21 | Traditional | PDF ↗ |
| K981704 | AUREX-3 | Adm Tronics Unltd, Inc. | 1998-08-05 | Traditional | PDF ↗ |
| K974501 | DIGITAL TINNITUS MASKING SYSTEM | Petroff Audio Technologies | 1998-01-20 | Traditional | PDF ↗ |
| K964216 | STARKEY TM-3, TM-5 HIGH FREQUENCY TINNITUS MASKER | Starkey Laboratories, Inc. | 1996-12-06 | Traditional | PDF ↗ |
| K963838 | STARKEY TM AIR CONDUCTION TINNITUS MASKER | Starkey Laboratories, Inc. | 1996-11-26 | Traditional | PDF ↗ |
| K963995 | STARKEY MA-3 AIR CONDUCTION COMBINATION HEARING AID/TINNITUS MASKER | Starkey Laboratories, Inc. | 1996-11-26 | Traditional | PDF ↗ |
| K941834 | AUDITORY CASSETTE | Ltmlt, Inc. | 1994-10-31 | Traditional | PDF ↗ |
| K940567 | MODEL#1550 MARSONA(R) TINNITUS MASKER | Marpac, Inc. | 1994-07-06 | Traditional | PDF ↗ |
| K924991 | MICRO MASKER | Associated Hearing Instruments | 1993-06-14 | Traditional | PDF ↗ |
| K922572 | 321Q MINIMUM ENERGY TINNITUS SUPPRESSOR | Microbio-Medics, Inc. | 1992-11-02 | Traditional | PDF ↗ |
| K802750 | NUVOX BEDSIDE TINNITUS MASKER | Hal-Hen Co., Inc. | 1980-12-31 | Traditional | PDF ↗ |
| K802234 | BEDSIDE TINNITUS MASKER #1500 | Marpac, Inc. | 1980-10-10 | Traditional | PDF ↗ |
| K800702 | TA-641 TINNITUS INSTRUMENT | Audiotrone | 1980-05-08 | Traditional | PDF ↗ |
| K800784 | MINUET MASKER; JUBILEE MASKER | Beltone Electronics Corp. | 1980-04-29 | Traditional | PDF ↗ |
| K800701 | T-570 TINNITUS MASKER | Audiotrone | 1980-04-10 | Traditional | PDF ↗ |
| K791790 | MODEL TM5 BEHIND EAR TINNITUS MASKER | Starkey Laboratories, Inc. | 1979-10-26 | Traditional | PDF ↗ |
| K791142 | HEARING AID, MODEL MA-1 | Starkey Laboratories, Inc. | 1979-09-28 | Traditional | PDF ↗ |
| K791071 | MODEL MA3 BEHIND-THE-EAR MASKER/HEARING | Starkey Laboratories, Inc. | 1979-07-03 | Traditional | PDF ↗ |
| K790190 | TINNITUS MASKERS MODEL S584 | Vican Instrument Co. | 1979-02-12 | Traditional | PDF ↗ |
| K781798 | TINNITUS MASKER | Starkey Laboratories, Inc. | 1978-11-03 | Traditional | PDF ↗ |
| K780546 | BEHIND-THE-EAR MASKING AMPLIFIER,735S | Danavox, Inc. | 1978-04-10 | Traditional | PDF ↗ |
| K771769 | TINNITUS MASKERS, MODELS S564&S574 | Vicon Instrument Co. | 1978-01-03 | Traditional | PDF ↗ |
| K770938 | TINNITUS AID, MODEL S244 | Vicon Instrument Co. | 1977-06-28 | Traditional | PDF ↗ |
Product code KLW · Class II · Ear, Nose, Throat. Data: openFDA.