510(k) · Cleared
ClearedAudifon Sueno Cic, Audifon Sueno S, Audifon Sueno T Cic, Audifon Sueno T S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Audifon-USA, Inc. · KLW Masker, Tinnitus
Cleared on Sep 12, 2013 as substantially equivalent to K091552 (Audifon GmbH & Co. KG, 2009) after a 205-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Sep 12, 2013
- Review
- 205 days
- Class
- Class II
- Product code
- KLW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K003558 (2001). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003558 | Tci Combi (Tinnitus Control Instrument Combination) | Siemens Hearing Instruments, Inc. | 2001 | — |
| −1 | K091552 | Switch TRT | Audifon GmbH & Co. KG | 2009 | — |
| 0 (this device) | K130417 | Audifon Sueno Cic, Audifon Sueno S, Audifon Sueno T Cic, Audifon Sueno T S | Audifon-USA, Inc. | 2013 | — |
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 |
|---|---|---|---|
| * | K091552 | Switch TRTSummary page 1…Werner-von-Siemens.Str. 2 D-99625 Kalleda Germany 9. Market Device with K09 1552 Substantial Equivalence: audifon switch TRT 10. Date of Preparation July 18, 2013… | 2009 |
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 12 years and passes through 3 companies; a new generation was cleared every 8.3 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K091552.
How does its category compare?
All KLW devicesKLW Masker, Tinnitus: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 devices are intended for the adult population suffering from a chronic persistent ringing in the ears (Tinnitus), who do not need or desire amplification. The products may be used for masking Tinnitus as part of a Tinnitus Retraining Therapy (TRT) protocol and should be utilized only in consultation with a licensed hearing healthcare professional, who is trained in subsequent rehabilitation therapy, or a qualified audiologist.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130417 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130417: Audifon Sueno Cic, Audifon Sueno S, Audifon Sueno T Cic, Audifon Sueno T S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130417
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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