510(k) · Cleared
ClearedTinnitus Soundsupport
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oticon A/S · KLW Masker, Tinnitus
Cleared on Mar 18, 2014 as substantially equivalent to K110932 (Gn Resound A/S, 2011) and 1 other predicate after a 141-day review. Its family tree reaches back 6 generations to 1998. 2 later devices descend from it.
- Decided
- Mar 18, 2014
- Review
- 141 days
- Class
- Class II
- Product code
- KLW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K974501 (1998). 12 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK974501 Digital Tinnitus Masking SystemPetroff Audio Technologies · 1998
- 5 generations backK030791 Anmp (Acoustic Neuro Modulation Protocol)Tinnitech, Ltd. · 2003
- 4 generations backK040330 QuiescenceSpectral Visualization & Development, Inc. · 2004
- 3 generations backK073636 Tinnitus Sound Generator ModuleGn Resound A/S · 2008
- 2 generations backK110932 Tinnitus Sound Generator ModuleGn Resound A/S · 2011
- 1 generation backK123450 Phonak Tinnitus BalancePhonak, LLC · 2013
- This deviceK133308 Tinnitus SoundsupportOticon A/S · 2014
- Descendant · cites it directly · 1 of its ownK151719 REVE134Kw Ear Lab, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK221168 Tinnitogram Signal GeneratorGoldenear Company, Inc. · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K974501 | Digital Tinnitus Masking System | Petroff Audio Technologies | 1998 | — |
| −5 | K030791 | Anmp (Acoustic Neuro Modulation Protocol) | Tinnitech, Ltd. | 2003 | — |
| −4 | K040330 | Quiescence | Spectral Visualization & Development, Inc. | 2004 | — |
| −3 | K073636 | Tinnitus Sound Generator Module | Gn Resound A/S | 2008 | — |
| −2 | K110932 | Tinnitus Sound Generator Module | Gn Resound A/S | 2011 | — |
| −1 | K123450 | Phonak Tinnitus Balance | Phonak, LLC | 2013 | — |
| 0 (this device) | K133308 | Tinnitus Soundsupport | Oticon A/S | 2014 | — |
| +1 | K151719 | REVE134 | Kw Ear Lab, Inc. | 2015 | — |
| +2 | K221168 | Tinnitogram Signal Generator | Goldenear Company, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 3 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2023 | 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 3…agement process Figure 7-2. Substantial equivalence Oticon's Tinnitus SoundSupport is as safe and effective as GnResound's Tinnitus Sound Generator (K1 10932) and Phonak's Tinnitus Balance Software (K123450). As shown in the table below, Oticon's Tinnitus SoundSupport, GnResound's… | 2011 |
| * | K123450 | Phonak Tinnitus BalanceSummary page 1…on: 21 C.F.R. §874.3400 Product Code: KLW Predicate Devices: Ki110932 Tinnitus Sound Generator, GnResound K123450 Tinnitus Balance Software, Phonak Intended Use / Indications for Use Tinnitus SoundSupport is a tool intended to ge… | 2013 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151719 | REVE134 | 2015 | 1 |
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 6 companies; a new generation was cleared every 3.1 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K151719 (Kw Ear Lab, Inc., 2015) has gone furthest, with 1 descendant 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. 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?
Tinnitus SoundSupport is a tool intended to generate sounds to provide temporary relief to patients suffering from tinnitus as part of a tinnitus management program.
The target population is the adult population (>18yrs).
Tinnitus SoundSupport is targeted for licensed hearing care professionals (audiologists, hearing aid specialists, or otolaryngologists) who are familiar with the evaluation and treatment of tinnitus and hearing losses. The fitting of Tinnitus SoundSupport must be done by a hearing care professional participating in a tinnitus management program.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133308 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133308: Tinnitus Soundsupport.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133308
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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