Masker, Tinnitus
FDA product code KLW · Class II (moderate risk) · 21 CFR 874.3400 · Ear, Nose, Throat
78510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Starkey Laboratories, Inc. 10
- Gn Resound A/S 3
- GN Hearing A/S 3
- Audifon-USA, Inc. 3
- Siemens Hearing Instruments, Inc. 3
- Tinnitus Control, Inc. 2
- Audiotrone 2
- Marpac, Inc. 2
- Soundcure, Inc. 2
- Vicon Instrument Co. 2
- Tinnitus Treatment Centers, Inc. 2
- Ltmlt, Inc. 1
- Neurosim Limited 1
- Levo Medical Corporation 1
- Adm Tronics Unltd, Inc. 1
- Petroff Audio Technologies 1
- Associated Hearing Instruments 1
- Microbio-Medics, Inc. 1
- Hal-Hen Co., Inc. 1
- Vican Instrument Co. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260413 | Levo Gen 2 Tinnitus Therapy SystemKLW · Traditional | Levo Medical Corporation | 08/13/2026SE |
| K260614 | Tinnitus TherapyKLW · Special | Sivantos GmbH | 06/10/2026SE |
| K233435 | Peace N Quiet (0.7.0)KLW · Traditional | Pnq Health | 02/27/2024SE |
| K223694 | Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)KLW · Traditional | Duearity AB | 06/30/2023SE |
| K221168 | Tinnitogram Signal GeneratorKLW · Traditional | Goldenear Company, Inc. | 02/01/2023SE |
| K221125 | SilentCloudKLW · Traditional | Aureliym GmbH | 01/04/2023SE |
| K201370 | Multiflex Tinnitus TechnologyKLW · Special | Starkey Laboratories, Inc. | 06/19/2020SE |
| K193303 | Tinnitus Sound Generator ModuleKLW · Special | GN Hearing A/S | 02/20/2020SE |
| K180495 | Tinnitus Sound Generator ModuleKLW · Traditional | GN Hearing A/S | 11/30/2018SE |
| K181586 | Tinnitus Sound Generator ModuleKLW · Special | GN Hearing A/S | 07/13/2018SE |
| K171243 | audifon Tinnitus-ModuleKLW · Abbreviated | Audiofon USA, Inc. | 10/19/2017SE |
| K163094 | TinniLogic Mobile Tinnitus Management DeviceKLW · Traditional | Jiangsu Betterlife Medical Co., Ltd. | 05/17/2017SE |
| K161562 | Sound Options Tinnitus TreatmentKLW · Traditional | Sound Options Tinnitus Treatments, Inc. | 09/28/2016SE |
| K161331 | HyperSound Tinnitus ModuleKLW · Traditional | Turtle Beach Corporation | 08/23/2016SE |
| K151558 | Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro SystemKLW · Traditional | Neurotherapies Reset GmbH | 01/20/2016SE |
| K151719 | REVE134KLW · Traditional | Kw Ear Lab, Inc. | 10/09/2015SE |
| K150014 | SerenityKLW · Traditional | Sanuthera, Inc. | 07/27/2015SE |
| K150171 | Tinnitus Sound Generator ModuleKLW · Special | Gn Resound A/S | 05/14/2015SE |
| K150065 | SoundCure Serenade Tinnitus Treatment SystemKLW · Traditional | Soundcure, Inc. | 04/13/2015SE |
| K140845 | Levo Tinnitus Masking Software DeviceKLW · Traditional | Otoharmonics Corp | 07/18/2014SE |
| K132965 | Solace Sound GeneratorsKLW · Abbreviated | Amplisound Hearing Products & Services | 03/25/2014SE |
| K133308 | Tinnitus SoundsupportKLW · Traditional | Oticon A/S | 03/18/2014SE |
| K130937 | Wave 2G, SoulKLW · Traditional | Hansaton Akustik GmbH | 01/03/2014SE |
| K130514 | Audifon Arriva Cic, Is, Is+, M, S, S+, X TRT, Audifon Vico, Audifon Prado, Audifon Elia…KLW · Abbreviated | Audifon-USA, Inc. | 11/21/2013SE |
| K130417 | Audifon Sueno Cic, Audifon Sueno S, Audifon Sueno T Cic, Audifon Sueno T SKLW · Abbreviated | Audifon-USA, Inc. | 09/12/2013SE |
| K130494 | Unitron Tinnitus Masker FeatureKLW · Abbreviated | Unitron Hearing | 05/07/2013SE |
| K123450 | Phonak Tinnitus BalanceKLW · Abbreviated | Phonak, LLC | 02/11/2013SE |
| K122876 | Multiflex Tinnitus TechnologyKLW · Traditional | Starkey Laboratories | 10/31/2012SE |
| K112752 | Tinnitus Therapy System Anm T30 CRKLW · Traditional | Anm Adaptive Neuromodulation GmbH | 12/16/2011SE |
| K111293 | Soundcure Serenade Tinnitus Treatment SystemKLW · Traditional | Soundcure, Inc. | 08/24/2011SE |
| K110973 | Ie-Zen (in Clear Series Hearing Aid)KLW · Special | Widex USA | 05/05/2011SE |
| K110932 | Tinnitus Sound Generator ModuleKLW · Special | Gn Resound A/S | 05/03/2011SE |
| K093715 | Evok 900 Series Hearing Aid/Tinnitus Masker Option DeviceKLW · Abbreviated | Magnatone Hearing Aid Corp. Dba Persona Medical | 12/22/2010SE |
| K091552 | Switch TRTKLW · Abbreviated | Audifon GmbH & Co. KG | 08/12/2009SE |
| K083488 | Jump S+ TRT, Jump Cic TRT, Jump S TRT, Jump C TRTKLW · Abbreviated | Audifon-USA, Inc. | 02/19/2009SE |
| K080955 | Zen Program (Mind 440 Hearing Aid)KLW · Traditional | Widex Hearing Aid Co., Inc. | 06/27/2008SE |
| K073636 | Tinnitus Sound Generator ModuleKLW · Traditional | Gn Resound A/S | 03/13/2008SE |
| K070599 | Customized Sound Therapy (CST)KLW · Abbreviated | Tinnitus Otosound Products, LLC | 07/13/2007SE |
| K070648 | The Inhibitor, Model 001KLW · Traditional | Melmedtronics, Inc. | 06/29/2007SE |
| K061459 | Tranquil Tri-BteKLW · Special | General Hearing Instruments, Inc. | 06/30/2006SE |
| K061111 | Tinnitus Phase-OutKLW · Special | Tinnitus Control, Inc. | 05/16/2006SE |
| K043274 | Neuromonics Tinnitus TreatmentKLW · Traditional | Neuromonics Pty, Ltd. | 01/28/2005SE |
| K041302 | Refuge Sound GeneratorKLW · Traditional | Micro-Ear Technology, Inc. | 07/01/2004SE |
| K040330 | QuiescenceKLW · Traditional | Spectral Visualization & Development, Inc. | 04/12/2004SE |
| K030180 | Crescent Tinnitus Retaining Sound GeneratorKLW · Traditional | Starkey Laboratories, Inc. | 09/17/2003SE |
| K031624 | Tinnitus RXKLW · Traditional | Tinnitus Control, Inc. | 07/24/2003SE |
| K030791 | Anmp (Acoustic Neuro Modulation Protocol)KLW · Traditional | Tinnitech, Ltd. | 04/17/2003SE |
| K021202 | UltraquietKLW · Traditional | Sound Technique System, LLC | 07/13/2002SE |
| K013827 | TST - Suppressor Model #1000KLW · Traditional | Neurosim Limited | 05/21/2002SE |
| K013253 | Hisonic-Trd Tinnitus Relief DeviceKLW · Traditional | Hearing Innovations, Inc. | 04/05/2002SE |
| K011364 | Custom Tci (Tinnitus Control Instrument)KLW · Traditional | Siemens Hearing Instruments, Inc. | 06/07/2001SE |
| K011366 | Custom Tci-Combi (Tinnitus Control Instrument Combination)KLW · Traditional | Siemens Hearing Instruments, Inc. | 06/01/2001SE |
| K003559 | Tci (Tinnitus Control Instrument)KLW · Traditional | Siemens Hearing Instruments, Inc. | 04/26/2001SE |
| K982451 | Ttcghi-T and TTCTN3-T-TKLW · Traditional | Tinnitus Treatment Centers, Inc. | 05/07/1999SE |
| K982432 | Pillow Masker, C2007M, C2008M,CE2000, Wonder Ear, Mini Wonder Ear, PT-2SM, PT-3SM…KLW · Traditional | Tinnitus Treatment Centers, Inc. | 01/25/1999SE |
| K984243 | Telex Tinnitus-CompanionKLW · Traditional | Telex Communications, Inc. | 01/21/1999SE |
| K981704 | AUREX-3KLW · Traditional | Adm Tronics Unltd, Inc. | 08/05/1998SE |
| K974501 | Digital Tinnitus Masking SystemKLW · Traditional | Petroff Audio Technologies | 01/20/1998SE |
| K964216 | Starkey TM-3, TM-5 High Frequency Tinnitus MaskerKLW · Traditional | Starkey Laboratories, Inc. | 12/06/1996SE |
| K963995 | Starkey MA-3 Air Conduction Combination Hearing Aid/Tinnitus MaskerKLW · Traditional | Starkey Laboratories, Inc. | 11/26/1996SE |
| K963838 | Starkey TM Air Conduction Tinnitus MaskerKLW · Traditional | Starkey Laboratories, Inc. | 11/26/1996SE |
| K941834 | Auditory CassetteKLW · Traditional | Ltmlt, Inc. | 10/31/1994SE |
| K940567 | MODEL#1550 Marsona(R) Tinnitus MaskerKLW · Traditional | Marpac, Inc. | 07/06/1994SE |
| K924991 | Micro MaskerKLW · Traditional | Associated Hearing Instruments | 06/14/1993SE |
| K922572 | 321Q Minimum Energy Tinnitus SuppressorKLW · Traditional | Microbio-Medics, Inc. | 11/02/1992SE |
| K802750 | Nuvox Bedside Tinnitus MaskerKLW · Traditional | Hal-Hen Co., Inc. | 12/31/1980SE |
| K802234 | Bedside Tinnitus Masker #1500KLW · Traditional | Marpac, Inc. | 10/10/1980SE |
| K800702 | TA-641 Tinnitus InstrumentKLW · Traditional | Audiotrone | 05/08/1980SE |
| K800784 | Minuet Masker; Jubilee MaskerKLW · Traditional | Beltone Electronics Corp. | 04/29/1980SE |
| K800701 | T-570 Tinnitus MaskerKLW · Traditional | Audiotrone | 04/10/1980SE |
| K791790 | Model TM5 Behind Ear Tinnitus MaskerKLW · Traditional | Starkey Laboratories, Inc. | 10/26/1979SE |
| K791142 | Hearing Aid, Model MA-1KLW · Traditional | Starkey Laboratories, Inc. | 09/28/1979SE |
| K791071 | Model MA3 Behind-The-Ear Masker/HearingKLW · Traditional | Starkey Laboratories, Inc. | 07/03/1979SE |
| K790190 | Tinnitus Maskers Model S584KLW · Traditional | Vican Instrument Co. | 02/12/1979SE |
| K781798 | Tinnitus MaskerKLW · Traditional | Starkey Laboratories, Inc. | 11/03/1978SE |
| K780546 | Behind-The-Ear Masking AMPLIFIER,735SKLW · Traditional | Danavox, Inc. | 04/10/1978SE |
| K771769 | Tinnitus Maskers, Models S564&S574KLW · Traditional | Vicon Instrument Co. | 01/03/1978SE |
| K770938 | Tinnitus Aid, Model S244KLW · Traditional | Vicon Instrument Co. | 06/28/1977SE |