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 Hearing A/S · KLW Masker, Tinnitus
Cleared on Feb 20, 2020 as substantially equivalent to K180495 (GN Hearing A/S, 2018) after an 83-day review. Its family tree reaches back 8 generations to 1998.
- Decided
- Feb 20, 2020
- Review
- 83 days
- Class
- Class II
- Product code
- KLW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K974501 (1998). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK974501 Digital Tinnitus Masking SystemPetroff Audio Technologies · 1998
- 7 generations backK030791 Anmp (Acoustic Neuro Modulation Protocol)Tinnitech, Ltd. · 2003
- 6 generations backK040330 QuiescenceSpectral Visualization & Development, Inc. · 2004
- 5 generations backK073636 Tinnitus Sound Generator ModuleGn Resound A/S · 2008
- 4 generations backK110932 Tinnitus Sound Generator ModuleGn Resound A/S · 2011
- 3 generations backK150171 Tinnitus Sound Generator ModuleGn Resound A/S · 2015
- 2 generations backK181586 Tinnitus Sound Generator ModuleGN Hearing A/S · 2018
- 1 generation backK180495 Tinnitus Sound Generator ModuleGN Hearing A/S · 2018
- This deviceK193303 Tinnitus Sound Generator ModuleGN Hearing A/S · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K974501 | Digital Tinnitus Masking System | Petroff Audio Technologies | 1998 | — |
| −7 | K030791 | Anmp (Acoustic Neuro Modulation Protocol) | Tinnitech, Ltd. | 2003 | — |
| −6 | K040330 | Quiescence | Spectral Visualization & Development, Inc. | 2004 | — |
| −5 | K073636 | Tinnitus Sound Generator Module | Gn Resound A/S | 2008 | — |
| −4 | K110932 | Tinnitus Sound Generator Module | Gn Resound A/S | 2011 | — |
| −3 | K150171 | Tinnitus Sound Generator Module | Gn Resound A/S | 2015 | — |
| −2 | K181586 | Tinnitus Sound Generator Module | GN Hearing A/S | 2018 | — |
| −1 | K180495 | Tinnitus Sound Generator Module | GN Hearing A/S | 2018 | — |
| 0 (this device) | K193303 | Tinnitus Sound Generator Module | GN Hearing A/S | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K180495 | Tinnitus Sound Generator ModuleSummary page 4…Class II Classification Panel: Ear, Nose, and Throat Product Code: KLW III) PREDICATE DEVICE Predicate Device: K180495 IV) DEVICE DESCRIPTION The Tinnitus Sound Generator (TSG) Module is software that provides a means for healthcare prof… | 2018 |
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 22 years and passes through 5 companies; a new generation was cleared every 3.2 years on median.
- None of the 10 ancestors has a recall.
How does its category compare?
All KLW devicesKLW Masker, Tinnitus: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 temporarily relieve patients suffering from Tinnitus. 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…
Read the full statement (140 words)
The Tinnitus Sound Generator Module is a tool to generate sounds to be used in a Tinnitus Management Program to temporarily relieve patients suffering from Tinnitus. 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 initial fitting of the Tinnitus Sound Generator Module must be done during an in-office visit by a hearing professional participating in a Tinnitus Management Program. If deemed feasible by the hearing professional, subsequent fittings of the Tinnitus Sound Generator Module may be performed remotely and in real time while having live communication via live audio, video and chat on the user’s dedicated app.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193303 · printed Nov 4, 2026
Cite this page
510(k) Report. “K193303: 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/K193303
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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