510(k) · Cleared
ClearedNeuromonics Tinnitus Treatment
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neuromonics Pty, Ltd. · KLW Masker, Tinnitus
Cleared on Jan 28, 2005 as substantially equivalent to K030791 (Tinnitech, Ltd., 2003) and 2 other predicates after a 63-day review. Its family tree reaches back 2 generations to 1998. 7 later devices descend from it.
- Decided
- Jan 28, 2005
- Review
- 63 days
- Class
- Class II
- Product code
- KLW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K974501 (1998). 3 ancestors in all. 7 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK974501 Digital Tinnitus Masking SystemPetroff Audio Technologies · 1998
- 1 generation backK030791 Anmp (Acoustic Neuro Modulation Protocol)Tinnitech, Ltd. · 2003
- This deviceK043274 Neuromonics Tinnitus TreatmentNeuromonics Pty, Ltd. · 2005
- 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 |
|---|---|---|---|---|---|
| −2 | K974501 | Digital Tinnitus Masking System | Petroff Audio Technologies | 1998 | — |
| −1 | K030791 | Anmp (Acoustic Neuro Modulation Protocol) | Tinnitech, Ltd. | 2003 | — |
| 0 (this device) | K043274 | Neuromonics Tinnitus Treatment | Neuromonics Pty, Ltd. | 2005 | — |
| +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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2023 | 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? (3)
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 |
|---|---|---|---|
| * | K030791 | Anmp (Acoustic Neuro Modulation Protocol)Summary page 2…claiming substantial equivalence to three devices: Equivalence is claimed to the TinniTech ANMP System, manufactured by Neuromonics (formerly TinniTech), 510k number SD K030791 Equivalence is claimed to the Dynamic Tinnitus Mitigation System, DTM-6 manufactured by Petroff Audio Technologies Inc. 510k num… | 2003 |
| * | K974501 | Digital Tinnitus Masking SystemSummary page 2…TinniTech), 510k number SD K030791 Equivalence is claimed to the Dynamic Tinnitus Mitigation System, DTM-6 manufactured by Petroff Audio Technologies Inc. 510k number; K974501 Equivalence is also claimed to the Custom TCI Instrument manufactured by Siemens Hearing Instruments, 510k number; KO11364. Page… | 1998 |
| * | K011364 | Custom Tci (Tinnitus Control Instrument)Summary page 3…f the predicate device, provide digital tinnitus interaction sounds together with selected musical sounds to promote relaxation during the tinnitus interaction process. K011364 Like the predicate device, KO11364, the Neuromonics Tinnitus Treatment custom-tailors the audio signals on both Phase 1 and Phas… | 2001 |
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?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K080955 (Widex Hearing Aid Co., Inc., 2008) has gone furthest, with 5 descendants of its own.
- 5 other devices also cite its predicate K030791.
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 Neuromonics Tinnitus Treatment System comprises an SD Memory Card, the Neuromonics Processor, a portable, stereo, MP3 player, and Earphones. The Memory Card has been pre-recorded with selected relaxation music and other sounds spectrally adjusted to suit the particular patient’s spectral hearing thresholds as shown by their audiogram. The sounds on the SD Memory Card are reproduced by the Neuromonics Processor and delivered to the ears by the Bang…
Read the full statement (189 words)
The Neuromonics Tinnitus Treatment System comprises an SD Memory Card,
the Neuromonics Processor, a portable, stereo, MP3 player, and Earphones. The
Memory Card has been pre-recorded with selected relaxation music and other
sounds spectrally adjusted to suit the particular patient’s spectral hearing
thresholds as shown by their audiogram. The sounds on the SD Memory Card
are reproduced by the Neuromonics Processor and delivered to the ears by the
Bang and Olufsen earphones. The device is indicated for adult (18 years and
over) tinnitus sufferers who may or may not suffer hearing loss and are
participating in the Neuromonics Tinnitus Treatment.
The Neuromonics Tinnitus Treatment System is for home use under the direction
of an appropriately qualified healthcare professional such as-an otolaryngologist,
an audiologist, or a licensed hearing aid dealer.
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 the Neuromonics Tinnitus Treatment.
The Neuromonics Tinnitus Treatment System may be used to fully and
intermittently interact with / mask their tinnitus perception.
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/K043274 · printed Nov 3, 2026
Cite this page
510(k) Report. “K043274: Neuromonics Tinnitus Treatment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K043274
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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