KLW · Masker, Tinnitus
Ear, Nose, Throat · 21 CFR 874.3400 · Class 2
Overview
| Product Code | KLW |
|---|---|
| Device Name | Masker, Tinnitus |
| Regulation | 21 CFR 874.3400 |
| Device Class | Class 2 |
| Review Panel | Ear, Nose, Throat |
| 3rd-Party Reviewable | Yes |
Identification
A tinnitus masker is an electronic device intended to generate noise of sufficient intensity and bandwidth to mask ringing in the ears or internal head noises. Because the device is able to mask internal noises, it is also used as an aid in hearing external noises and speech.
Classification Rationale
Class II. The special control for this device is patient labeling regarding:(1) Hearing health care professional diagnosis, fitting of the device, and followup care, (2) Risks, (3) Benefits, (4) Warnings for safe use, and (5) Specifications.
Special Controls
The special control for this device is patient labeling regarding:(1) Hearing health care professional diagnosis, fitting of the device, and followup care, (2) Risks, (3) Benefits, (4) Warnings for safe use, and (5) Specifications.
Recent Cleared Devices (20 of 76)
Showing 20 most recent of 76 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K233435 | Peace N Quiet (0.7.0) | Pnq Health | Feb 27, 2024 | SESE |
| K223694 | Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042) | Duearity AB | Jun 30, 2023 | SESE |
| K221168 | Tinnitogram Signal Generator | Goldenear Company, Inc. | Feb 1, 2023 | SESE |
| K221125 | SilentCloud | Aureliym GmbH | Jan 4, 2023 | SESE |
| K201370 | Multiflex Tinnitus Technology | Starkey Laboratories, Inc. | Jun 19, 2020 | SESE |
| K193303 | Tinnitus Sound Generator Module | GN Hearing A/S | Feb 20, 2020 | SESE |
| K180495 | Tinnitus Sound Generator Module | GN Hearing A/S | Nov 30, 2018 | SESE |
| K181586 | Tinnitus Sound Generator Module | GN Hearing A/S | Jul 13, 2018 | SESE |
| K171243 | audifon Tinnitus-Module | Audiofon USA, Inc. | Oct 19, 2017 | SESE |
| K163094 | TinniLogic Mobile Tinnitus Management Device | Jiangsu Betterlife Medical Co., Ltd. | May 17, 2017 | SESE |
| K161562 | Sound Options Tinnitus Treatment | Sound Options Tinnitus Treatments, Inc. | Sep 28, 2016 | SESE |
| K161331 | HyperSound Tinnitus Module | Turtle Beach Corporation | Aug 23, 2016 | SESE |
| K151558 | Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System | Neurotherapies Reset GmbH | Jan 20, 2016 | SESE |
| K151719 | REVE134 | Kw Ear Lab, Inc. | Oct 9, 2015 | SESE |
| K150014 | Serenity | Sanuthera, Inc. | Jul 27, 2015 | SESE |
| K150171 | Tinnitus Sound Generator Module | Gn Resound A/S | May 14, 2015 | SESE |
| K150065 | SoundCure Serenade Tinnitus Treatment System | Soundcure, Inc. | Apr 13, 2015 | SESE |
| K140845 | LEVO TINNITUS MASKING SOFTWARE DEVICE | Otoharmonics Corp | Jul 18, 2014 | SESE |
| K132965 | SOLACE SOUND GENERATORS | Amplisound Hearing Products & Services | Mar 25, 2014 | SESE |
| K133308 | TINNITUS SOUNDSUPPORT | Oticon A/S | Mar 18, 2014 | SESE |
Top Applicants
- Starkey Laboratories, Inc. — 9 clearances
- Audifon-USA, Inc. — 3 clearances
- GN Hearing A/S — 3 clearances
- Gn Resound A/S — 3 clearances
- Siemens Hearing Instruments, Inc. — 3 clearances
