510(k) · Cleared
ClearedSolace Sound Generators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amplisound Hearing Products & Services · KLW Masker, Tinnitus
Cleared on Mar 25, 2014 as substantially equivalent to K073636 (Gn Resound A/S, 2008) and 1 other predicate after a 186-day review. Its family tree reaches back 4 generations to 1998.
- Decided
- Mar 25, 2014
- Review
- 186 days
- Class
- Class II
- Product code
- KLW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K974501 (1998). 12 ancestors in all, the oldest K791790 (1979). No later device cites it as a predicate yet.
- Root · 4 generations backK974501 Digital Tinnitus Masking SystemPetroff Audio Technologies · 1998
- 3 generations backK030791 Anmp (Acoustic Neuro Modulation Protocol)Tinnitech, Ltd. · 2003
- 2 generations backK040330 QuiescenceSpectral Visualization & Development, Inc. · 2004
- 1 generation backK073636 Tinnitus Sound Generator ModuleGn Resound A/S · 2008
- This deviceK132965 Solace Sound GeneratorsAmplisound Hearing Products & Services · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K974501 | Digital Tinnitus Masking System | Petroff Audio Technologies | 1998 | — |
| −3 | K030791 | Anmp (Acoustic Neuro Modulation Protocol) | Tinnitech, Ltd. | 2003 | — |
| −2 | K040330 | Quiescence | Spectral Visualization & Development, Inc. | 2004 | — |
| −1 | K073636 | Tinnitus Sound Generator Module | Gn Resound A/S | 2008 | — |
| 0 (this device) | K132965 | Solace Sound Generators | Amplisound Hearing Products & Services | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 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 |
|---|---|---|---|
| * | K073636 | Tinnitus Sound Generator ModuleSummary page 1…ASSIFICATION NAME: 21 CFR 874.3400 (Tinnitus Masker Class 11) PRODUCT CODE: KLW PREDICATE DEVICES: Resound TSG Module K073636 TTC's GHI-T &TN3-TTinnitus Masker K982451… | 2008 |
| * | K982451 | Ttcghi-T and TTCTN3-T-TSummary page 1…ODUCT CODE: KLW PREDICATE DEVICES: Resound TSG Module K073636 TTC's GHI-T &TN3-TTinnitus Masker K982451 Pag… | 1999 |
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 16 years and passes through 5 companies; a new generation was cleared every 5.2 years on median.
- None of the 12 ancestors has a recall.
- 3 other devices also cite its predicate K073636.
How does its category compare?
All KLW devicesKLW Masker, Tinnitus: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
Quell sound generators are designed for individuals who experience tinnitus. These devices generate a digitally controlled passive analog broad band noise from the circuit. The broad band noise is intended for use with tinnitus masking therapy. These devices are to be dispensed only by a doctor, licensed audiologist, or licensed hearing instrument specialist who are trained in the area of tinnitus treatment. BTE worn sound generators are one of several available sound stimuli means such as; computer generated audio, CD player, iPod, sound pillows, etc. Sound generators are dispensed to an adult population 18 years of age or above with specific instructions for their use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132965 · printed Nov 4, 2026
Cite this page
510(k) Report. “K132965: Solace Sound Generators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K132965
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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