510(k) · Cleared
ClearedZen Program (Mind 440 Hearing Aid)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Widex Hearing Aid Co., Inc. · KLW Masker, Tinnitus
Cleared on Jun 27, 2008 as substantially equivalent to K043274 (Neuromonics Pty, Ltd., 2005) and 2 other predicates after an 85-day review. Its family tree reaches back 3 generations to 1998. 5 later devices descend from it.
- Decided
- Jun 27, 2008
- Review
- 85 days
- Class
- Class II
- Product code
- KLW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K974501 (1998). 5 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK974501 Digital Tinnitus Masking SystemPetroff Audio Technologies · 1998
- 2 generations backK030791 Anmp (Acoustic Neuro Modulation Protocol)Tinnitech, Ltd. · 2003
- 1 generation backK043274 Neuromonics Tinnitus TreatmentNeuromonics Pty, Ltd. · 2005
- This deviceK080955 Zen Program (Mind 440 Hearing Aid)Widex Hearing Aid Co., Inc. · 2008
- Descendant · cites it directly · 4 of its ownK110973 IE-Zen (in Clear Series Hearing Aid)Widex USA · 2011
- Descendant · 2 generations on · 3 of its ownK123450 Phonak Tinnitus BalancePhonak, LLC · 2013
- Descendant · 3 generations on · 2 of its ownK133308 Tinnitus SoundsupportOticon A/S · 2014
- Descendant · 4 generations on · 1 of its ownK151719 REVE134Kw Ear Lab, Inc. · 2015
- Descendant · 5 generations on · 0 of its ownK221168 Tinnitogram Signal GeneratorGoldenear Company, Inc. · 2023
Most influential descendants
Showing 5 of 5 · See all- K110973IE-Zen (in Clear Series Hearing Aid)Widex USA · 2011 · cites it directly4descendants
- K123450Phonak Tinnitus BalancePhonak, LLC · 2013 · 2 generations on3descendants
- K133308Tinnitus SoundsupportOticon A/S · 2014 · 3 generations on2descendants
- K151719REVE134Kw Ear Lab, Inc. · 2015 · 4 generations on1descendant
- K221168Tinnitogram Signal GeneratorGoldenear Company, Inc. · 2023 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K974501 | Digital Tinnitus Masking System | Petroff Audio Technologies | 1998 | — |
| −2 | K030791 | Anmp (Acoustic Neuro Modulation Protocol) | Tinnitech, Ltd. | 2003 | — |
| −1 | K043274 | Neuromonics Tinnitus Treatment | Neuromonics Pty, Ltd. | 2005 | — |
| 0 (this device) | K080955 | Zen Program (Mind 440 Hearing Aid) | Widex Hearing Aid Co., Inc. | 2008 | — |
| +1 | K110973 | IE-Zen (in Clear Series Hearing Aid) | Widex USA | 2011 | — |
| +2 | K123450 | Phonak Tinnitus Balance | Phonak, LLC | 2013 | — |
| +3 | K133308 | Tinnitus Soundsupport | Oticon A/S | 2014 | — |
| +4 | K151719 | REVE134 | Kw Ear Lab, Inc. | 2015 | — |
| +5 | K221168 | Tinnitogram Signal Generator | Goldenear Company, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 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 |
|---|---|---|---|
| * | K043274 | Neuromonics Tinnitus TreatmentSummary page 1…DK-3500 Vaerloese Denmark Reason for Submission New Product Marketed Devices with K043274 Neuronomics Tinnitus Treatment Substantial Equivalence K(011366 Siemens Custom TCI-Combi… | 2005 |
| * | K011366 | Custom Tci-Combi (Tinnitus Control Instrument Combination) Our reading of the summary gave K001366, FDA’s number for Prostec 125I Branchytherapy Snapseed (Prostec, LLC). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Siemens Custom TCI-Combi”. | 2001 |
| * | K974501 | Digital Tinnitus Masking SystemSummary page 1…es with K043274 Neuronomics Tinnitus Treatment Substantial Equivalence K(011366 Siemens Custom TCI-Combi K974501 Digital tinnitus masking system Compliance with Section 514, PerformanceStandards Not applicable… | 1998 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110973 | IE-Zen (in Clear Series Hearing Aid) | 2011 | 4 |
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 10 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K110973 (Widex USA, 2011) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K043274.
How does its category compare?
All KLW devicesKLW Masker, Tinnitus: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 Zen program is intended to provide a relaxing sound background for adults (21 years and older) who desire to listen to such a background in quiet. It may be used as a sound therapy tool in a tinnitus treatment program that is prescribed by a licensed hearing healthcare professional (audiologists, hearing aid specialists, otolaryngologists) who is trained in tinnitus management.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080955 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080955: Zen Program (Mind 440 Hearing Aid).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080955
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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