510(k) · Cleared
ClearedUnitron Tinnitus Masker Feature
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Unitron Hearing · KLW Masker, Tinnitus
Cleared on May 7, 2013 as substantially equivalent to K110932 (Gn Resound A/S, 2011) after a 70-day review. Its family tree reaches back 5 generations to 1998. 1 later device descends from it.
- Decided
- May 7, 2013
- Review
- 70 days
- Class
- Class II
- Product code
- KLW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K974501 (1998). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- 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 deviceK130494 Unitron Tinnitus Masker FeatureUnitron Hearing · 2013
- Descendant · cites it directly · 0 of its ownK150014 SerenitySanuthera, Inc. · 2015
Most influential descendants
Showing 1 of 1 · See all- K150014SerenitySanuthera, Inc. · 2015 · cites it directly0descendants
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) | K130494 | Unitron Tinnitus Masker Feature | Unitron Hearing | 2013 | — |
| +1 | K150014 | Serenity | Sanuthera, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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? (1)
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 1…11 Classification Name: Tinnitus Masker Product Code: KLW Regulation Number: 21 CFR §874.3400 Tinnitus Masker Predicate Device(s): K110932, GN ReSound Tinnitus Sound Generator Module Description of Device: Unitron's Tinnitus Masker feature is a noise generator a… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150014 | Serenity | 2015 | 0 |
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 15 years and passes through 5 companies; a new generation was cleared every 3.1 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K150014 (Sanuthera, Inc., 2015) has gone furthest, with 0 descendants of its own.
- 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. 2013, 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?
Unitron's tinnitus masker is a broadband sound generator available in Unitron Era hearing aid platforms. It provides a means of sound enrichment therapy that can be used as part of a personalized tinnitus management program to provide temporary relief from tinnitus. Tinnitus masker is intended for adults 18 years of age or older who have both hearing loss and tinnitus. The tinnitus masker within the air conduction hearing instrument is fitted by a…
Read the full statement (122 words)
Unitron's tinnitus masker is a broadband sound generator available in Unitron Era hearing aid platforms. It provides a means of sound enrichment therapy that can be used as part of a personalized tinnitus management program to provide temporary relief from tinnitus.
Tinnitus masker is intended for adults 18 years of age or older who have both hearing loss and tinnitus. The tinnitus masker within the air conduction hearing instrument is fitted by a hearing health care professional familiar with diagnosis and management of tinnitus.
The underlying principle of sound enrichment is to provide supplementary noise stimulation which can help defocus your attention from your tinnitus and avoid negative reactions. Sound enrichment coupled with instructional counseling, is an established approach to managing tinnitus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130494 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130494: Unitron Tinnitus Masker Feature.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130494
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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