510(k) · Cleared
ClearedSwitch TRT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Audifon GmbH & Co. KG · KLW Masker, Tinnitus
Cleared on Aug 12, 2009 as substantially equivalent to K003558 (Siemens Hearing Instruments, Inc., 2001) after a 77-day review. Its family tree reaches back 1 generation to 2001. 3 later devices descend from it.
- Decided
- Aug 12, 2009
- Review
- 77 days
- Class
- Class II
- Product code
- KLW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003558 (2001). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK003558 Tci Combi (Tinnitus Control Instrument Combination)Siemens Hearing Instruments, Inc. · 2001
- This deviceK091552 Switch TRTAudifon GmbH & Co. KG · 2009
- Descendant · cites it directly · 1 of its ownK130514 Audifon Arriva Cic, IS, IS+, M, S, S+, X TRT, Audifon Vico, Audifon…Audifon-USA, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK171243 audifon Tinnitus-ModuleAudiofon USA, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK130417 Audifon Sueno Cic, Audifon Sueno S, Audifon Sueno T Cic, Audifon…Audifon-USA, Inc. · 2013
Most influential descendants
Showing 3 of 3 · See all- K130514Audifon Arriva Cic, IS, IS+, M, S, S+, X TRT, Audifon Vico, Audifon Prado, Audifon Elia…Audifon-USA, Inc. · 2013 · cites it directly1descendant
- K171243audifon Tinnitus-ModuleAudiofon USA, Inc. · 2017 · 2 generations on0descendants
- K130417Audifon Sueno Cic, Audifon Sueno S, Audifon Sueno T Cic, Audifon Sueno T SAudifon-USA, Inc. · 2013 · cites it directly0descendants
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) | K091552 | Switch TRT | Audifon GmbH & Co. KG | 2009 | — |
| +1 | K130514 | Audifon Arriva Cic, IS, IS+, M, S, S+, X TRT, Audifon Vico, Audifon Prado… | Audifon-USA, Inc. | 2013 | — |
| +2 | K171243 | audifon Tinnitus-Module | Audiofon USA, Inc. | 2017 | — |
| +1 | K130417 | Audifon Sueno Cic, Audifon Sueno S, Audifon Sueno T Cic, Audifon Sueno T S | Audifon-USA, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2017 | 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? (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 1…ns-Str. 2 D-99625 K611eda Germany 9. Market Device with K003558 Substantial Equivalence Siemens TCI Combi Description of Device Device Name: aud… | 2001 |
What descends from it? (3)
2 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?
How does its category compare?
All KLW devicesKLW Masker, Tinnitus: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 switch TRT is addressed to the adult population with a chronic persistent ringing in the ears (Tinnitus), who do not need or desire amplification. It may be used for masking tinnitus as part of tinnitus management program that is prescribed by a licensed hearing healthcare professional, who is trained in subsequent rehabilitation therapy, or a qualified audiologist. Therefore it generates a broadband noise with sufficient bandwidth and intensity and…
Read the full statement (163 words)
The switch TRT is addressed to the adult population with a chronic persistent ringing in the ears (Tinnitus), who do not need or desire amplification. It may be used for masking tinnitus as part of tinnitus management program that is prescribed by a licensed hearing healthcare professional, who is trained in subsequent rehabilitation therapy, or a qualified audiologist. Therefore it generates a broadband noise with sufficient bandwidth and intensity and is applied on the ear.
The switch 8 TRT is addressed to the adult population with a chronic persistent ringing in the ears (Tinnitus), who also need or desire amplification. The amplification suits the needs of a mild to a moderate hearing loss.
It may be used for masking tinnitus as part of tinnitus management program that is prescribed by a licensed hearing healthcare professional, who is trained in subsequent rehabilitation therapy, or a qualified audiologist. Therefore it generates a broadband noise with sufficient bandwidth and intensity and is applied on the ear.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091552 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091552: Switch TRT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091552
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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