Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KLW — Predicate Candidate Screening
77 FDA 510(k) clearances under this product code; the 50 most recent screened below.
88 daysmedian FDA review time
256 days90th percentile
77clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260614 | Tinnitus Therapy | Sivantos GmbH | 2026-06-10 | 105 | 0 |
| K233435 | Peace N Quiet (0.7.0) | Pnq Health | 2024-02-27 | 137 | 0 |
| K223694 | Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042) | Duearity AB | 2023-06-30 | 203 | 0 |
| K221168 | Tinnitogram Signal Generator | Goldenear Company, Inc. | 2023-02-01 | 285 | 0 |
| K221125 | SilentCloud | Aureliym GmbH | 2023-01-04 | 261 | 0 |
| K201370 | Multiflex Tinnitus Technology | Starkey Laboratories, Inc. | 2020-06-19 | 28 | 0 |
| K193303 | Tinnitus Sound Generator Module | GN Hearing A/S | 2020-02-20 | 83 | 0 |
| K180495 | Tinnitus Sound Generator Module | GN Hearing A/S | 2018-11-30 | 277 | 0 |
| K181586 | Tinnitus Sound Generator Module | GN Hearing A/S | 2018-07-13 | 28 | 0 |
| K171243 | audifon Tinnitus-Module | Audiofon USA, Inc. | 2017-10-19 | 174 | 0 |
| K163094 | TinniLogic Mobile Tinnitus Management Device | Jiangsu Betterlife Medical Co., Ltd. | 2017-05-17 | 194 | 0 |
| K161562 | Sound Options Tinnitus Treatment | Sound Options Tinnitus Treatments, Inc. | 2016-09-28 | 114 | 0 |
| K161331 | HyperSound Tinnitus Module | Turtle Beach Corporation | 2016-08-23 | 103 | 0 |
| K151558 | Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus | Neurotherapies Reset GmbH | 2016-01-20 | 224 | 0 |
| K151719 | REVE134 | Kw Ear Lab, Inc. | 2015-10-09 | 106 | 0 |
| K150014 | Serenity | Sanuthera, Inc. | 2015-07-27 | 203 | 0 |
| K150171 | Tinnitus Sound Generator Module | Gn Resound A/S | 2015-05-14 | 108 | 0 |
| K150065 | SoundCure Serenade Tinnitus Treatment System | Soundcure, Inc. | 2015-04-13 | 90 | 0 |
| K140845 | LEVO TINNITUS MASKING SOFTWARE DEVICE | Otoharmonics Corp | 2014-07-18 | 107 | 0 |
| K132965 | SOLACE SOUND GENERATORS | Amplisound Hearing Products & Services | 2014-03-25 | 186 | 0 |
| K133308 | TINNITUS SOUNDSUPPORT | Oticon A/S | 2014-03-18 | 141 | 0 |
| K130937 | WAVE 2G, SOUL | Hansaton Akustik GmbH | 2014-01-03 | 274 | 0 |
| K130514 | AUDIFON ARRIVA CIC, IS, IS+, M, S, S+, X TRT, AUDIFON VICO, | Audifon-USA, Inc. | 2013-11-21 | 267 | 0 |
| K130417 | AUDIFON SUENO CIC, AUDIFON SUENO S, AUDIFON SUENO T CIC, AUD | Audifon-USA, Inc. | 2013-09-12 | 205 | 0 |
| K130494 | UNITRON TINNITUS MASKER FEATURE | Unitron Hearing | 2013-05-07 | 70 | 0 |
| K123450 | PHONAK TINNITUS BALANCE | Phonak, LLC | 2013-02-11 | 94 | 0 |
| K122876 | MULTIFLEX TINNITUS TECHNOLOGY | Starkey Laboratories | 2012-10-31 | 42 | 0 |
| K112752 | TINNITUS THERAPY SYSTEM ANM T30 CR | Anm Adaptive Neuromodulation GmbH | 2011-12-16 | 86 | 0 |
| K111293 | SOUNDCURE SERENADE TINNITUS TREATMENT SYSTEM | Soundcure, Inc. | 2011-08-24 | 110 | 0 |
| K110973 | IE-ZEN (IN CLEAR SERIES HEARING AID) | Widex USA | 2011-05-05 | 29 | 0 |
| K110932 | TINNITUS SOUND GENERATOR MODULE | Gn Resound A/S | 2011-05-03 | 29 | 0 |
| K093715 | EVOK 900 SERIES HEARING AID/TINNITUS MASKER OPTION DEVICE | Magnatone Hearing Aid Corp. Dba Persona Medical | 2010-12-22 | 386 | 0 |
| K091552 | SWITCH TRT | Audifon GmbH & Co. KG | 2009-08-12 | 77 | 0 |
| K083488 | JUMP S+ TRT, JUMP CIC TRT, JUMP S TRT, JUMP C TRT | Audifon-USA, Inc. | 2009-02-19 | 86 | 0 |
| K080955 | ZEN PROGRAM (MIND 440 HEARING AID) | Widex Hearing Aid Co., Inc. | 2008-06-27 | 85 | 0 |
| K073636 | TINNITUS SOUND GENERATOR MODULE | Gn Resound A/S | 2008-03-13 | 78 | 0 |
| K070599 | CUSTOMIZED SOUND THERAPY (CST) | Tinnitus Otosound Products, LLC | 2007-07-13 | 133 | 0 |
| K070648 | THE INHIBITOR, MODEL 001 | Melmedtronics, Inc. | 2007-06-29 | 113 | 0 |
| K061459 | TRANQUIL TRI-BTE | General Hearing Instruments, Inc. | 2006-06-30 | 35 | 0 |
| K061111 | TINNITUS PHASE-OUT | Tinnitus Control, Inc. | 2006-05-16 | 25 | 0 |
| K043274 | NEUROMONICS TINNITUS TREATMENT | Neuromonics Pty, Ltd. | 2005-01-28 | 63 | 0 |
| K041302 | REFUGE SOUND GENERATOR | Micro-Ear Technology, Inc. | 2004-07-01 | 48 | 0 |
| K040330 | QUIESCENCE | Spectral Visualization & Development, Inc. | 2004-04-12 | 61 | 0 |
| K030180 | CRESCENT TINNITUS RETAINING SOUND GENERATOR | Starkey Laboratories, Inc. | 2003-09-17 | 243 | 0 |
| K031624 | TINNITUS RX | Tinnitus Control, Inc. | 2003-07-24 | 62 | 0 |
| K030791 | ANMP (ACOUSTIC NEURO MODULATION PROTOCOL) | Tinnitech, Ltd. | 2003-04-17 | 36 | 0 |
| K021202 | ULTRAQUIET | Sound Technique System, LLC | 2002-07-13 | 88 | 0 |
| K013827 | TST - SUPPRESSOR MODEL #1000 | Neurosim Limited | 2002-05-21 | 183 | 0 |
| K013253 | HISONIC-TRD TINNITUS RELIEF DEVICE | Hearing Innovations, Inc. | 2002-04-05 | 189 | 0 |
| K011364 | CUSTOM TCI (TINNITUS CONTROL INSTRUMENT) | Siemens Hearing Instruments, Inc. | 2001-06-07 | 34 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda