510(k) · Cleared
ClearedTinnitus Therapy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sivantos GmbH · KLW Masker, Tinnitus
Cleared on Jun 10, 2026 as substantially equivalent to K003558 (Siemens Hearing Instruments, Inc., 2001) after a 105-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Jun 10, 2026
- Review
- 105 days
- Class
- Class II
- Product code
- KLW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003558 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK003558 Tci Combi (Tinnitus Control Instrument Combination)Siemens Hearing Instruments, Inc. · 2001
- This deviceK260614 Tinnitus TherapySivantos GmbH · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003558 | Tci Combi (Tinnitus Control Instrument Combination) | Siemens Hearing Instruments, Inc. | 2001 | — |
| 0 (this device) | K260614 | Tinnitus Therapy | Sivantos GmbH | 2026 | — |
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 |
|---|---|---|---|
| * | K003558 | Tci Combi (Tinnitus Control Instrument Combination)Summary page 5…Number: 21 CFR § 874.3400 Product Code: KLW Device Classification: Class II 3. Predicate Device: TCI-Combi Tinnitus Masker (cleared under K003558) 3.1. Reference Devices: Sound Options Tinnitus Treatment (cleared under K161562) Tinnitus Sound Generator Module (clear… | 2001 |
| † | K161562 | Sound Options Tinnitus Treatment | 2016 |
| † | K180495 | Tinnitus Sound Generator Module | 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?
- Its one ancestor has no recall.
- 4 other devices also cite its predicate K003558.
How does its category compare?
All KLW devicesKLW Masker, Tinnitus: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Therapy feature is intended to output noise of sufficient intensity and bandwidth to be used for tinnitus habituation therapy and is also suitable for tinnitus masking therapy. Tinnitus Therapy feature is intended to be used by those individuals who experience tinnitus and desire amplification. This device is fit by a qualified audiologist or other hearing healthcare professional familiar with the diagnosis of tinnitus and subsequent…
Read the full statement (110 words)
The Tinnitus Therapy feature is intended to output noise of sufficient intensity and bandwidth to be used for tinnitus habituation therapy and is also suitable for tinnitus masking therapy. Tinnitus Therapy feature is intended to be used by those individuals who experience tinnitus and desire amplification. This device is fit by a qualified audiologist or other hearing healthcare professional familiar with the diagnosis of tinnitus and subsequent rehabilitation therapy.
The target population is primarily the adult population over 18 years of age. The target group for this product includes individuals reporting tinnitus who do need amplification. This product may also be used with children 5 years of age or older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260614 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260614: Tinnitus Therapy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260614
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026