510(k) · Cleared
ClearedAnmp (Acoustic Neuro Modulation Protocol)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tinnitech, Ltd. · KLW Masker, Tinnitus
Cleared on Apr 17, 2003 as substantially equivalent to K974501 (Petroff Audio Technologies, 1998) and 1 other predicate after a 36-day review. Its family tree reaches back 1 generation to 1998. 31 later devices descend from it.
- Decided
- Apr 17, 2003
- Review
- 36 days
- Class
- Class II
- Product code
- KLW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K974501 (1998). 2 ancestors in all. 31 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK974501 Digital Tinnitus Masking SystemPetroff Audio Technologies · 1998
- This deviceK030791 Anmp (Acoustic Neuro Modulation Protocol)Tinnitech, Ltd. · 2003
- Descendant · cites it directly · 23 of its ownK040330 QuiescenceSpectral Visualization & Development, Inc. · 2004
- Descendant · 2 generations on · 22 of its ownK073636 Tinnitus Sound Generator ModuleGn Resound A/S · 2008
- Descendant · 3 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
- Descendant · 3 generations on · 6 of its ownK111293 Soundcure Serenade Tinnitus Treatment SystemSoundcure, Inc. · 2011
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K040330QuiescenceSpectral Visualization & Development, Inc. · 2004 · cites it directly23descendants
- K073636Tinnitus Sound Generator ModuleGn Resound A/S · 2008 · 2 generations on22descendants
- K110932Tinnitus Sound Generator ModuleGn Resound A/S · 2011 · 3 generations on13descendants
- K043274Neuromonics Tinnitus TreatmentNeuromonics Pty, Ltd. · 2005 · cites it directly7descendants
- K111293Soundcure Serenade Tinnitus Treatment SystemSoundcure, Inc. · 2011 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K974501 | Digital Tinnitus Masking System | Petroff Audio Technologies | 1998 | — |
| 0 (this device) | K030791 | Anmp (Acoustic Neuro Modulation Protocol) | Tinnitech, Ltd. | 2003 | — |
| +1 | K040330 | Quiescence | Spectral Visualization & Development, Inc. | 2004 | — |
| +2 | K073636 | Tinnitus Sound Generator Module | Gn Resound A/S | 2008 | — |
| +3 | K110932 | Tinnitus Sound Generator Module | Gn Resound A/S | 2011 | — |
| +1 | K043274 | Neuromonics Tinnitus Treatment | Neuromonics Pty, Ltd. | 2005 | — |
| +3 | K111293 | Soundcure Serenade Tinnitus Treatment System | Soundcure, Inc. | 2011 | — |
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 |
|---|---|---|
| 2003 | 1 | 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 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 |
|---|---|---|---|
| * | K974501 | Digital Tinnitus Masking SystemSummary page 3…stantial equivalence to two devices: Equivalence is claimed to the Dynamic Tinnitus Mitigation System, DTMB manufactured by Petroff Audio Technologies Inc. 51Ok number; K974501 Equivalence is also claimed to the Custom TCI Instrument manufactured by Siemens Hearing Instruments, 510k number; KO11364. K97… | 1998 |
| * | K011364 | Custom Tci (Tinnitus Control Instrument) | 2001 |
What descends from it? (31)
See all 316 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?
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 TinniTech ANMP System comprises two (2) mini compact disks and a portable, stereo, MP3 mini compact disc player with earphones. The discs have been prerecorded 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 discs are reproduced by the mini compact disc player and delivered to the ears by the earphones supplied with the…
Read the full statement (186 words)
The TinniTech ANMP System comprises two (2) mini compact disks and a portable, stereo, MP3 mini compact disc player with earphones. The discs have been prerecorded 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 discs are reproduced by the mini compact disc player and delivered to the ears by the earphones supplied with the player. 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 TinniTech ANMP 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 non-medical tinnitus management.
The Tinnitech ANMP System may be used to completely mask and intermittently mask tinnitus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030791 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030791: Anmp (Acoustic Neuro Modulation Protocol).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030791
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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