510(k) · Cleared
ClearedCustom Tci-Combi (Tinnitus Control Instrument Combination)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Hearing Instruments, Inc. · KLW Masker, Tinnitus
Cleared on Jun 1, 2001 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- Jun 1, 2001
- Review
- 28 days
- Class
- Class II
- Product code
- KLW
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK011366 Custom Tci-Combi (Tinnitus Control Instrument Combination)Siemens Hearing Instruments, Inc. · 2001
- Descendant · cites it directly · 5 of its ownK080955 Zen Program (Mind 440 Hearing Aid)Widex Hearing Aid Co., Inc. · 2008
- Descendant · 2 generations on · 4 of its ownK110973 IE-Zen (in Clear Series Hearing Aid)Widex USA · 2011
- Descendant · 3 generations on · 3 of its ownK123450 Phonak Tinnitus BalancePhonak, LLC · 2013
- Descendant · 4 generations on · 2 of its ownK133308 Tinnitus SoundsupportOticon A/S · 2014
- Descendant · 5 generations on · 1 of its ownK151719 REVE134Kw Ear Lab, Inc. · 2015
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K080955Zen Program (Mind 440 Hearing Aid)Widex Hearing Aid Co., Inc. · 2008 · cites it directly5descendants
- K110973IE-Zen (in Clear Series Hearing Aid)Widex USA · 2011 · 2 generations on4descendants
- K123450Phonak Tinnitus BalancePhonak, LLC · 2013 · 3 generations on3descendants
- K133308Tinnitus SoundsupportOticon A/S · 2014 · 4 generations on2descendants
- K151719REVE134Kw Ear Lab, Inc. · 2015 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011366 | Custom Tci-Combi (Tinnitus Control Instrument Combination) | Siemens Hearing Instruments, Inc. | 2001 | — |
| +1 | K080955 | Zen Program (Mind 440 Hearing Aid) | Widex Hearing Aid Co., Inc. | 2008 | — |
| +2 | K110973 | IE-Zen (in Clear Series Hearing Aid) | Widex USA | 2011 | — |
| +3 | K123450 | Phonak Tinnitus Balance | Phonak, LLC | 2013 | — |
| +4 | K133308 | Tinnitus Soundsupport | Oticon A/S | 2014 | — |
| +5 | K151719 | REVE134 | Kw Ear Lab, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (7)
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?
- Of its descendants, K080955 (Widex Hearing Aid Co., Inc., 2008) has gone furthest, with 5 descendants of its own.
How does its category compare?
All KLW devicesKLW Masker, Tinnitus: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K011366 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011366: Custom Tci-Combi (Tinnitus Control Instrument Combination).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011366
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026