510(k) · Cleared
ClearedTtcghi-T and TTCTN3-T-T
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tinnitus Treatment Centers, Inc. · KLW Masker, Tinnitus
Cleared on May 7, 1999 as substantially equivalent to K964216 (Starkey Laboratories, Inc., 1996) and 4 other predicates after a 296-day review. Its family tree reaches back 2 generations to 1994. 2 later devices descend from it.
- Decided
- May 7, 1999
- Review
- 296 days
- Class
- Class II
- Product code
- KLW
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K940667 (1994). 6 ancestors in all, the oldest K791790 (1979). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK940667 Starkey CE-8 TML, Starkey CE-8 TMC Air Conduction Hearing AidStarkey Laboratories, Inc. · 1994
- 1 generation backK963838 Starkey TM Air Conduction Tinnitus MaskerStarkey Laboratories, Inc. · 1996
- This deviceK982451 Ttcghi-T and TTCTN3-T-TTinnitus Treatment Centers, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK132965 Solace Sound GeneratorsAmplisound Hearing Products & Services · 2014
- Descendant · cites it directly · 0 of its ownK031624 Tinnitus RXTinnitus Control, Inc. · 2003
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K940667 | Starkey CE-8 TML, Starkey CE-8 TMC Air Conduction Hearing Aid | Starkey Laboratories, Inc. | 1994 | — |
| −1 | K963838 | Starkey TM Air Conduction Tinnitus Masker | Starkey Laboratories, Inc. | 1996 | — |
| 0 (this device) | K982451 | Ttcghi-T and TTCTN3-T-T | Tinnitus Treatment Centers, Inc. | 1999 | — |
| +1 | K132965 | Solace Sound Generators | Amplisound Hearing Products & Services | 2014 | — |
| +1 | K031624 | Tinnitus RX | Tinnitus Control, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2014 | 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? (5)
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 |
|---|---|---|---|
| * | K964216 | Starkey TM-3, TM-5 High Frequency Tinnitus MaskerSummary page 2…TM3-T Tape Recorded Noise Tinnitus Masking None Assigned (submitted and pending) Class I, Tier 2 ~ Ear, Nose and Throat 874.3400 77KLW Substantial Equivalence to: K964216 (Starkey TM-3, TM-5 High Frequency Masker) K974501 (Digital Tinnitus Masking System) K963838 (Starkey TM Air Conduction Tinnitus… | 1996 |
| * | K974501 | Digital Tinnitus Masking SystemSummary page 2…ssigned (submitted and pending) Class I, Tier 2 ~ Ear, Nose and Throat 874.3400 77KLW Substantial Equivalence to: K964216 (Starkey TM-3, TM-5 High Frequency Masker) K974501 (Digital Tinnitus Masking System) K963838 (Starkey TM Air Conduction Tinnitus Masker) K791790 (Starkey TM-5 Behind Ear Tinnitus… | 1998 |
| * | K963838 | Starkey TM Air Conduction Tinnitus MaskerSummary page 2…ier 2 ~ Ear, Nose and Throat 874.3400 77KLW Substantial Equivalence to: K964216 (Starkey TM-3, TM-5 High Frequency Masker) K974501 (Digital Tinnitus Masking System) K963838 (Starkey TM Air Conduction Tinnitus Masker) K791790 (Starkey TM-5 Behind Ear Tinnitus Masker) K974751 (General Hearing Inst. Tra… | 1996 |
| * | K791790 | Model TM5 Behind Ear Tinnitus MaskerSummary page 2…antial Equivalence to: K964216 (Starkey TM-3, TM-5 High Frequency Masker) K974501 (Digital Tinnitus Masking System) K963838 (Starkey TM Air Conduction Tinnitus Masker) K791790 (Starkey TM-5 Behind Ear Tinnitus Masker) K974751 (General Hearing Inst. Tranquil Tinnitus Masker) The noise used in the Tinnit… | 1979 |
| * | K974751 | Tranquil Tri-OE, Tranquil Tri-Coe, Tranquil Tri-CicSummary page 2…High Frequency Masker) K974501 (Digital Tinnitus Masking System) K963838 (Starkey TM Air Conduction Tinnitus Masker) K791790 (Starkey TM-5 Behind Ear Tinnitus Masker) K974751 (General Hearing Inst. Tranquil Tinnitus Masker) The noise used in the Tinnitus Adaptation Therapy program is a broad-band noise… | 1998 |
What descends from it? (2)
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?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K132965 (Amplisound Hearing Products & Services, 2014) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K964216.
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 | — |
What is it indicated for?
The noise used in the Tinnitus Adaptation Therapy program is a broad-band noise that has been recorded onto a standard audio cassette and can be played on any commercially available audio cassette player and listened to through any commercially available headphones or speakers. The noise is used as an adjunct to assist individuals with tinnitus to learn to refocus their attention away from their tinnitus and towards an alternate sound such as the…
Read the full statement (198 words)
The noise used in the Tinnitus Adaptation Therapy program is a broad-band noise that has been recorded onto a standard audio cassette and can be played on any commercially available audio cassette player and listened to through any commercially available headphones or speakers. The noise is used as an adjunct to assist individuals with tinnitus to learn to refocus their attention away from their tinnitus and towards an alternate sound such as the recorded noise. The level of the noise should be adjusted by the individual to a level below their tinnitus so that both the noise and the tinnitus can be heard simultaneously. However, if the individual wishes to completely “mask-out” the tinnitus then the noise could be adjusted so that the noise is louder than the tinnitus.
The other audio tapes in the Tinnitus Adaptation Therapy program consist of relaxation exercises and cognitive retraining lessons to further assist the individual with tinnitus to learn to refocus their attention away from their tinnitus.
The noise and the relaxation/cognitive tapes, when used in a comprehensive tinnitus adaptation therapy program, are indicated for the temporary relief of tinnitus symptoms and the promotion of relaxation during the tinnitus adaptation process.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982451 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982451: Ttcghi-T and TTCTN3-T-T.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982451
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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