Product code KLW
- Device name
- Masker, Tinnitus
- Medical specialty
- Ear, Nose, Throat
- Device class
- 2
- Regulation number
- 874.3400
- Review panel
- EN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260614 | Tinnitus Therapy | Sivantos GmbH | 2026-06-10 |
| K233435 | Peace N Quiet (0.7.0) | Pnq Health | 2024-02-27 |
| K223694 | Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042) | Duearity AB | 2023-06-30 |
| K221168 | Tinnitogram Signal Generator | Goldenear Company, Inc. | 2023-02-01 |
| K221125 | SilentCloud | Aureliym GmbH | 2023-01-04 |
| K201370 | Multiflex Tinnitus Technology | Starkey Laboratories, Inc. | 2020-06-19 |
| K193303 | Tinnitus Sound Generator Module | GN Hearing A/S | 2020-02-20 |
| K180495 | Tinnitus Sound Generator Module | GN Hearing A/S | 2018-11-30 |
| K181586 | Tinnitus Sound Generator Module | GN Hearing A/S | 2018-07-13 |
| K171243 | audifon Tinnitus-Module | Audiofon USA, Inc. | 2017-10-19 |
| K163094 | TinniLogic Mobile Tinnitus Management Device | Jiangsu Betterlife Medical Co., Ltd. | 2017-05-17 |
| K161562 | Sound Options Tinnitus Treatment | Sound Options Tinnitus Treatments, Inc. | 2016-09-28 |
| K161331 | HyperSound Tinnitus Module | Turtle Beach Corporation | 2016-08-23 |
| K151558 | Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System | Neurotherapies Reset GmbH | 2016-01-20 |
| K151719 | REVE134 | Kw Ear Lab, Inc. | 2015-10-09 |
| K150014 | Serenity | Sanuthera, Inc. | 2015-07-27 |
| K150171 | Tinnitus Sound Generator Module | Gn Resound A/S | 2015-05-14 |
| K150065 | SoundCure Serenade Tinnitus Treatment System | Soundcure, Inc. | 2015-04-13 |
| K140845 | LEVO TINNITUS MASKING SOFTWARE DEVICE | Otoharmonics Corp | 2014-07-18 |
| K132965 | SOLACE SOUND GENERATORS | Amplisound Hearing Products & Services | 2014-03-25 |
| K133308 | TINNITUS SOUNDSUPPORT | Oticon A/S | 2014-03-18 |
| K130937 | WAVE 2G, SOUL | Hansaton Akustik GmbH | 2014-01-03 |
| 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 |
| K130417 | AUDIFON SUENO CIC, AUDIFON SUENO S, AUDIFON SUENO T CIC, AUDIFON SUENO T S | Audifon-USA, Inc. | 2013-09-12 |
| K130494 | UNITRON TINNITUS MASKER FEATURE | Unitron Hearing | 2013-05-07 |
| K123450 | PHONAK TINNITUS BALANCE | Phonak, LLC | 2013-02-11 |
| K122876 | MULTIFLEX TINNITUS TECHNOLOGY | Starkey Laboratories | 2012-10-31 |
| K112752 | TINNITUS THERAPY SYSTEM ANM T30 CR | Anm Adaptive Neuromodulation GmbH | 2011-12-16 |
| K111293 | SOUNDCURE SERENADE TINNITUS TREATMENT SYSTEM | Soundcure, Inc. | 2011-08-24 |
| K110973 | IE-ZEN (IN CLEAR SERIES HEARING AID) | Widex USA | 2011-05-05 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05714878800291 | MIRACLE EAR | Ws Audiology Usa, Inc. | 2026-07-29 |
| 05714878800307 | MIRACLE EAR | Ws Audiology Usa, Inc. | 2026-07-29 |
| 05714878800314 | MIRACLE EAR | Ws Audiology Usa, Inc. | 2026-07-29 |
| 05714878800352 | MIRACLE EAR | Ws Audiology Usa, Inc. | 2026-07-29 |
| 07613389842067 | Moxi S7-RX | Sonova AG | 2026-07-26 |
| 07613389842036 | Moxi S7-RX | Sonova AG | 2026-07-26 |
| 07613389842074 | Moxi S9-RX | Sonova AG | 2026-07-26 |
| 07613389842081 | Moxi S9-RX | Sonova AG | 2026-07-26 |
| 07613389842098 | Moxi S9-RX | Sonova AG | 2026-07-26 |
| 07613389842104 | Moxi S9-RX | Sonova AG | 2026-07-26 |
| 07613389842111 | Moxi S-RX FLEX:TRIAL | Sonova AG | 2026-07-26 |
| 07613389843682 | Relate5.0 Platinum RIC RX | Sonova AG | 2026-07-26 |
| 07613389843699 | Relate5.0 RIC RX DEMO | Sonova AG | 2026-07-26 |
| 07613389844627 | Relate5.0 Gold RIC RX | Sonova AG | 2026-07-26 |
| 07613389844634 | Relate5.0 Gold RIC RX | Sonova AG | 2026-07-26 |
| 07613389844641 | Relate5.0 Gold RIC RX | Sonova AG | 2026-07-26 |
| 07613389844658 | Relate5.0 Platinum RIC RX | Sonova AG | 2026-07-26 |
| 07613389842050 | Moxi S7-RX | Sonova AG | 2026-07-26 |
| 07613389842043 | Moxi S7-RX | Sonova AG | 2026-07-26 |
| 07613389842029 | Moxi S7-RX | Sonova AG | 2026-07-26 |
| 07613389842012 | Moxi S7-RX | Sonova AG | 2026-07-26 |
| 07613389840605 | Moxi S9-RX | Sonova AG | 2026-07-26 |
| 07613389840599 | Moxi S9-RX | Sonova AG | 2026-07-26 |
| 00840388220641 | NuEar NE NXG AI | Starkey Laboratories, Inc. | 2026-07-02 |
| 00840388220719 | NuEar NE Series AI | Starkey Laboratories, Inc. | 2026-07-02 |
| 00840388220733 | NuEar NE Series AI | Starkey Laboratories, Inc. | 2026-07-02 |
| 00840388220726 | NuEar NE Series AI | Starkey Laboratories, Inc. | 2026-07-02 |
| 00840388220702 | NuEar NE NXG AI | Starkey Laboratories, Inc. | 2026-07-02 |
| 00840388220696 | NuEar NE NXG AI | Starkey Laboratories, Inc. | 2026-07-02 |
| 00840388220689 | NuEar NE NXG AI | Starkey Laboratories, Inc. | 2026-07-02 |