510(k) · Cleared
ClearedHyperSound Tinnitus Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Turtle Beach Corporation · KLW Masker, Tinnitus
Cleared on Aug 23, 2016 as substantially equivalent to K110932 (Gn Resound A/S, 2011) and 1 other predicate after a 103-day review. Its family tree reaches back 5 generations to 1998.
- Decided
- Aug 23, 2016
- Review
- 103 days
- Class
- Class II
- Product code
- KLW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K974501 (1998). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK974501 Digital Tinnitus Masking SystemPetroff Audio Technologies · 1998
- 4 generations backK030791 Anmp (Acoustic Neuro Modulation Protocol)Tinnitech, Ltd. · 2003
- 3 generations backK040330 QuiescenceSpectral Visualization & Development, Inc. · 2004
- 2 generations backK073636 Tinnitus Sound Generator ModuleGn Resound A/S · 2008
- 1 generation backK110932 Tinnitus Sound Generator ModuleGn Resound A/S · 2011
- This deviceK161331 HyperSound Tinnitus ModuleTurtle Beach Corporation · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K974501 | Digital Tinnitus Masking System | Petroff Audio Technologies | 1998 | — |
| −4 | K030791 | Anmp (Acoustic Neuro Modulation Protocol) | Tinnitech, Ltd. | 2003 | — |
| −3 | K040330 | Quiescence | Spectral Visualization & Development, Inc. | 2004 | — |
| −2 | K073636 | Tinnitus Sound Generator Module | Gn Resound A/S | 2008 | — |
| −1 | K110932 | Tinnitus Sound Generator Module | Gn Resound A/S | 2011 | — |
| 0 (this device) | K161331 | HyperSound Tinnitus Module | Turtle Beach Corporation | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2011 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KLW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KLW device
- #1 K260413 Levo Gen 2 Tinnitus Therapy Systemscore 11.8 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K110932 | Tinnitus Sound Generator ModuleSummary page 4…Name: Tinnitus Masker Classification Regulation: 21 C.F.R. 874.3400 Product Code: KLW Predicate Devices: K110932 GN Resound Tinnitus Sound Generator K111293 SoundCure™ Serenade™ Tinni… | 2011 |
| * | K111293 | Soundcure Serenade Tinnitus Treatment SystemSummary page 4…Product Code: KLW Predicate Devices: K110932 GN Resound Tinnitus Sound Generator K111293 SoundCure™ Serenade™ Tinnitus Treatment System INDICATION FOR… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 5 companies; a new generation was cleared every 3.9 years on median.
- None of the 8 ancestors has a recall.
- 6 other devices also cite its predicate K110932.
How does its category compare?
All KLW devicesKLW Masker, Tinnitus: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · KLW
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · KLW
261in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KLW
No recall names KLW since 2007.
Adverse event reports per year · KLW
4in 2015
MAUDE reports naming product code KLW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 1 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 4 | 58 | 0 | 1 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 4 | 150 | 0 | 0 |
| 2014 | 4 | 164 | 0 | 0 |
| 2015 | 4 | 107 | 0 | 4 |
| 2016 | 3 | 114 | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 3 | 261 | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The HyperSound Tinnitus Module is indicated for patient home use in the temporary relief of tinnitus symptoms. The device is available in HyperSound Clear 500P audio systems to generate and deliver personalized sound output to tinnitus patients with or without hearing loss and with or without hearing aids. Any fitting of the device must be done by a hearing care professional. The target population is primarily adults (18 years or older).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161331 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161331: HyperSound Tinnitus Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161331
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026