510(k) · Cleared
ClearedDigital Tinnitus Masking System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Petroff Audio Technologies · KLW Masker, Tinnitus
Cleared on Jan 20, 1998 after a 53-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 34 later devices descend from it.
- Decided
- Jan 20, 1998
- Review
- 53 days
- Class
- Class II
- Product code
- KLW
- Recalls
- None
- Predicates
- 0
34 later devices descend from it, 6 citing it directly.
- This deviceK974501 Digital Tinnitus Masking SystemPetroff Audio Technologies · 1998
- Descendant · cites it directly · 31 of its ownK030791 Anmp (Acoustic Neuro Modulation Protocol)Tinnitech, Ltd. · 2003
- Descendant · 2 generations on · 23 of its ownK040330 QuiescenceSpectral Visualization & Development, Inc. · 2004
- Descendant · 3 generations on · 22 of its ownK073636 Tinnitus Sound Generator ModuleGn Resound A/S · 2008
- Descendant · 4 generations on · 13 of its ownK110932 Tinnitus Sound Generator ModuleGn Resound A/S · 2011
- Descendant · cites it directly · 7 of its ownK043274 Neuromonics Tinnitus TreatmentNeuromonics Pty, Ltd. · 2005
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K030791Anmp (Acoustic Neuro Modulation Protocol)Tinnitech, Ltd. · 2003 · cites it directly31descendants
- K040330QuiescenceSpectral Visualization & Development, Inc. · 2004 · 2 generations on23descendants
- K073636Tinnitus Sound Generator ModuleGn Resound A/S · 2008 · 3 generations on22descendants
- K110932Tinnitus Sound Generator ModuleGn Resound A/S · 2011 · 4 generations on13descendants
- K043274Neuromonics Tinnitus TreatmentNeuromonics Pty, Ltd. · 2005 · cites it directly7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974501 | Digital Tinnitus Masking System | Petroff Audio Technologies | 1998 | — |
| +1 | K030791 | Anmp (Acoustic Neuro Modulation Protocol) | Tinnitech, Ltd. | 2003 | — |
| +2 | K040330 | Quiescence | Spectral Visualization & Development, Inc. | 2004 | — |
| +3 | K073636 | Tinnitus Sound Generator Module | Gn Resound A/S | 2008 | — |
| +4 | K110932 | Tinnitus Sound Generator Module | Gn Resound A/S | 2011 | — |
| +1 | K043274 | Neuromonics Tinnitus Treatment | Neuromonics Pty, Ltd. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (34)
See all 346 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030791 | Anmp (Acoustic Neuro Modulation Protocol) | 2003 | 31 |
| K043274 | Neuromonics Tinnitus Treatment | 2005 | 7 |
| K080955 | Zen Program (Mind 440 Hearing Aid) | 2008 | 5 |
| K982451 | Ttcghi-T and TTCTN3-T-T | 1999 | 2 |
| K070599 | Customized Sound Therapy (CST) | 2007 | 0 |
| K982432 | Pillow Masker, C2007M, C2008M,CE2000, Wonder Ear, Mini Wonder Ear, PT-2SM, PT-3SM… | 1999 | 0 |
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, K030791 (Tinnitech, Ltd., 2003) has gone furthest, with 31 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 | — |
What is it indicated for?
Each of the four CDs included in the DTM-4 CD set (CD#1, CD#2, CD#3 and CD#4), and each of the four tapes included the DTM-4 TAPE set (TAPE#1, TAPE#2, TAPE#3 and TAPE#4), provide digital tinnitus masking when operated on any commercially available CD or tape player respectively, using any commercially available headphones or speakers. CD#1 and TAPE#1 provide digital tinnitus masking sounds only and are indicated for temporary relief of tinnitus symptoms.…
Read the full statement (120 words)
Each of the four CDs included in the DTM-4 CD set (CD#1, CD#2, CD#3 and CD#4), and each of the four tapes included the DTM-4 TAPE set (TAPE#1, TAPE#2, TAPE#3 and TAPE#4), provide digital tinnitus masking when operated on any commercially available CD or tape player respectively, using any commercially available headphones or speakers. CD#1 and TAPE#1 provide digital tinnitus masking sounds only and are indicated for temporary relief of tinnitus symptoms. CD#2, CD#3, CD#4, TAPE#2, TAPE#3 and TAPE#4 provide digital tinnitus masking sounds plus relaxation messages, alpha-rhythms (a gentle musical sound generated on electronic musical instruments}), music and/or nature sounds, and are indicated for temporary relief of tinnitus symptoms and the promotion of relaxation during the tinnitus masking process.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974501 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974501: Digital Tinnitus Masking System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974501
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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