510(k) · Cleared
ClearedTinnitus RX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tinnitus Control, Inc. · KLW Masker, Tinnitus
Cleared on Jul 24, 2003 as substantially equivalent to K982451 (Tinnitus Treatment Centers, Inc., 1999) and 1 other predicate after a 62-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Jul 24, 2003
- Review
- 62 days
- Class
- Class II
- Product code
- KLW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K940667 (1994). 9 ancestors in all, the oldest K791790 (1979). No later device cites it as a predicate yet.
- Root · 3 generations backK940667 Starkey CE-8 TML, Starkey CE-8 TMC Air Conduction Hearing AidStarkey Laboratories, Inc. · 1994
- 2 generations backK963838 Starkey TM Air Conduction Tinnitus MaskerStarkey Laboratories, Inc. · 1996
- 1 generation backK982451 Ttcghi-T and TTCTN3-T-TTinnitus Treatment Centers, Inc. · 1999
- This deviceK031624 Tinnitus RXTinnitus Control, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K940667 | Starkey CE-8 TML, Starkey CE-8 TMC Air Conduction Hearing Aid | Starkey Laboratories, Inc. | 1994 | — |
| −2 | K963838 | Starkey TM Air Conduction Tinnitus Masker | Starkey Laboratories, Inc. | 1996 | — |
| −1 | K982451 | Ttcghi-T and TTCTN3-T-T | Tinnitus Treatment Centers, Inc. | 1999 | — |
| 0 (this device) | 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 |
| 2001 | 1 | 0 |
| 2003 | 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? (2)
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 |
|---|---|---|---|
| * | K982451 | Ttcghi-T and TTCTN3-T-TSummary page 2…phunes or spc8kw. 5. Bails for Substantial Equiveleace The Tinnitus Rx is substantially equbdent to the 7TCOHI-T and TTCTM-3 tinnitus maalrm. devices cleprcd lmdar K98245 1 and the TinniTGch ANMP W c o cleared undcr KO3 079 1. All of the d c v i a v usc sound to tcmpordly rclievo a & a t ’ s tinnitu… | 1999 |
| * | K030791 | Anmp (Acoustic Neuro Modulation Protocol) | 2003 |
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 9 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- None of the 9 ancestors has a recall.
- 1 other device also cites its predicate K982451.
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 Tinnitus Rx consists of a personalized sound recorded onto a compact disc (CD) that can be played on commercially available players and listened to through commercially available headphones. The recorded sound is equivalent to that generated by a qualified hearing healthcare professional who has followed the treatment regimen utilized in the clinical study (provided in the 510(k)). The device is indicated for adult (18 years and over) tinnitus…
Read the full statement (156 words)
The Tinnitus Rx consists of a personalized sound recorded onto a compact disc (CD) that can be played on commercially available players and listened to through commercially available headphones. The recorded sound is equivalent to that generated by a qualified hearing healthcare professional who has followed the treatment regimen utilized in the clinical study (provided in the 510(k)). The device is indicated for adult (18 years and over) tinnitus sufferers who may or may not suffer higher frequencies hearing loss and are participating in a tinnitus management program.
The Tinnitus Rx is for home use under the direction of an appropriately qualified healthcare professional.
Patients should receive a medical evaluation by a licensed physician (preferably a physician who specializes in diseases of the ear) to rule out medically or surgically treatable diseases for which tinnitus is a symptom before proceeding with non-medical tinnitus management.
The Tinnitus Rx is intended for the temporary relief of tinnitus symptoms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031624 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031624: Tinnitus RX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031624
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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