510(k) · Cleared
ClearedTinnitus Sound Generator Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gn Resound A/S · KLW Masker, Tinnitus
Cleared on Mar 13, 2008 as substantially equivalent to K040330 (Spectral Visualization & Development, Inc., 2004) and 1 other predicate after a 78-day review. Its family tree reaches back 3 generations to 1998. 22 later devices descend from it.
- Decided
- Mar 13, 2008
- Review
- 78 days
- Class
- Class II
- Product code
- KLW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K974501 (1998). 5 ancestors in all. 22 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK974501 Digital Tinnitus Masking SystemPetroff Audio Technologies · 1998
- 2 generations backK030791 Anmp (Acoustic Neuro Modulation Protocol)Tinnitech, Ltd. · 2003
- 1 generation backK040330 QuiescenceSpectral Visualization & Development, Inc. · 2004
- This deviceK073636 Tinnitus Sound Generator ModuleGn Resound A/S · 2008
- Descendant · cites it directly · 13 of its ownK110932 Tinnitus Sound Generator ModuleGn Resound A/S · 2011
- Descendant · cites it directly · 6 of its ownK111293 Soundcure Serenade Tinnitus Treatment SystemSoundcure, Inc. · 2011
- Descendant · 2 generations on · 3 of its ownK150171 Tinnitus Sound Generator ModuleGn Resound A/S · 2015
- Descendant · 2 generations on · 3 of its ownK123450 Phonak Tinnitus BalancePhonak, LLC · 2013
- Descendant · 3 generations on · 2 of its ownK181586 Tinnitus Sound Generator ModuleGN Hearing A/S · 2018
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K110932Tinnitus Sound Generator ModuleGn Resound A/S · 2011 · cites it directly13descendants
- K111293Soundcure Serenade Tinnitus Treatment SystemSoundcure, Inc. · 2011 · cites it directly6descendants
- K150171Tinnitus Sound Generator ModuleGn Resound A/S · 2015 · 2 generations on3descendants
- K123450Phonak Tinnitus BalancePhonak, LLC · 2013 · 2 generations on3descendants
- K181586Tinnitus Sound Generator ModuleGN Hearing A/S · 2018 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K974501 | Digital Tinnitus Masking System | Petroff Audio Technologies | 1998 | — |
| −2 | K030791 | Anmp (Acoustic Neuro Modulation Protocol) | Tinnitech, Ltd. | 2003 | — |
| −1 | K040330 | Quiescence | Spectral Visualization & Development, Inc. | 2004 | — |
| 0 (this device) | K073636 | Tinnitus Sound Generator Module | Gn Resound A/S | 2008 | — |
| +1 | K110932 | Tinnitus Sound Generator Module | Gn Resound A/S | 2011 | — |
| +1 | K111293 | Soundcure Serenade Tinnitus Treatment System | Soundcure, Inc. | 2011 | — |
| +2 | K150171 | Tinnitus Sound Generator Module | Gn Resound A/S | 2015 | — |
| +2 | K123450 | Phonak Tinnitus Balance | Phonak, LLC | 2013 | — |
| +3 | K181586 | Tinnitus Sound Generator Module | GN Hearing A/S | 2018 | — |
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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K040330 | QuiescenceSummary page 1…ce containing the Tinnitus sound generator module is fitted by a healthcare professional to fit the exact needs of the tinnitus patient. Predicate Devices: Quiescence K040330 Siemens TCI-Combi K003558 Intended Use: The Tinnitus Sound Generator Module is a tool to generate sounds to be used in a tinnit… | 2004 |
| * | K003558 | Tci Combi (Tinnitus Control Instrument Combination)Summary page 1…sound generator module is fitted by a healthcare professional to fit the exact needs of the tinnitus patient. Predicate Devices: Quiescence K040330 Siemens TCI-Combi K003558 Intended Use: The Tinnitus Sound Generator Module is a tool to generate sounds to be used in a tinnitus management program to r… | 2001 |
What descends from it? (22)
See all 224 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 10 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K110932 (Gn Resound A/S, 2011) has gone furthest, with 13 descendants of its own.
How does its category compare?
All KLW devicesKLW Masker, Tinnitus: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Tinnitus Sound Generator Module is a tool to generate sounds to be used in a tinnitus management program to relieve patients suffering from tinnitjs. The target population is primarily the adult population over 18 years of age. This product may also be used with children 5 years of age or older.
The Tinnitus Sound Generator module is targeted for healthcare professionals, which are treating patients suffering from tinnitus, as well as conventional hearing disorders. The fitting of the Tinnitus Sound generator module must be done by hearing professional participating in a tinnitus management program.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073636 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073636: Tinnitus Sound Generator Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073636
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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