510(k) · Cleared
ClearedModel TM5 Behind Ear Tinnitus Masker
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Starkey Laboratories, Inc. · KLW Masker, Tinnitus
Cleared on Oct 26, 1979 after a 45-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Oct 26, 1979
- Review
- 45 days
- Class
- Class II
- Product code
- KLW
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK791790 Model TM5 Behind Ear Tinnitus MaskerStarkey Laboratories, Inc. · 1979
- Descendant · cites it directly · 2 of its ownK982451 Ttcghi-T and TTCTN3-T-TTinnitus Treatment Centers, Inc. · 1999
- Descendant · cites it directly · 1 of its ownK013253 Hisonic-TRD Tinnitus Relief DeviceHearing Innovations, Inc. · 2002
- Descendant · 2 generations on · 0 of its ownK132965 Solace Sound GeneratorsAmplisound Hearing Products & Services · 2014
- Descendant · 2 generations on · 0 of its ownK070648 The Inhibitor, Model 001Melmedtronics, Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK031624 Tinnitus RXTinnitus Control, Inc. · 2003
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K982451Ttcghi-T and TTCTN3-T-TTinnitus Treatment Centers, Inc. · 1999 · cites it directly2descendants
- K013253Hisonic-TRD Tinnitus Relief DeviceHearing Innovations, Inc. · 2002 · cites it directly1descendant
- K132965Solace Sound GeneratorsAmplisound Hearing Products & Services · 2014 · 2 generations on0descendants
- K070648The Inhibitor, Model 001Melmedtronics, Inc. · 2007 · 2 generations on0descendants
- K031624Tinnitus RXTinnitus Control, Inc. · 2003 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K791790 | Model TM5 Behind Ear Tinnitus Masker | Starkey Laboratories, Inc. | 1979 | — |
| +1 | K982451 | Ttcghi-T and TTCTN3-T-T | Tinnitus Treatment Centers, Inc. | 1999 | — |
| +1 | K013253 | Hisonic-TRD Tinnitus Relief Device | Hearing Innovations, Inc. | 2002 | — |
| +2 | K132965 | Solace Sound Generators | Amplisound Hearing Products & Services | 2014 | — |
| +2 | K070648 | The Inhibitor, Model 001 | Melmedtronics, Inc. | 2007 | — |
| +2 | K031624 | Tinnitus RX | Tinnitus Control, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2014 | 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? (6)
3 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, K982451 (Tinnitus Treatment Centers, Inc., 1999) has gone furthest, with 2 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/K791790 · printed Nov 5, 2026
Cite this page
510(k) Report. “K791790: Model TM5 Behind Ear Tinnitus Masker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K791790
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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