510(k) · Cleared
ClearedIE-Zen (in Clear Series Hearing Aid)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Widex USA · KLW Masker, Tinnitus
Cleared on May 5, 2011 as substantially equivalent to K080955 (Widex Hearing Aid Co., Inc., 2008) after a 29-day review. Its family tree reaches back 4 generations to 1998. 4 later devices descend from it.
- Decided
- May 5, 2011
- Review
- 29 days
- Class
- Class II
- Product code
- KLW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K974501 (1998). 6 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK974501 Digital Tinnitus Masking SystemPetroff Audio Technologies · 1998
- 3 generations backK030791 Anmp (Acoustic Neuro Modulation Protocol)Tinnitech, Ltd. · 2003
- 2 generations backK043274 Neuromonics Tinnitus TreatmentNeuromonics Pty, Ltd. · 2005
- 1 generation backK080955 Zen Program (Mind 440 Hearing Aid)Widex Hearing Aid Co., Inc. · 2008
- This deviceK110973 IE-Zen (in Clear Series Hearing Aid)Widex USA · 2011
- Descendant · cites it directly · 3 of its ownK123450 Phonak Tinnitus BalancePhonak, LLC · 2013
- Descendant · 2 generations on · 2 of its ownK133308 Tinnitus SoundsupportOticon A/S · 2014
- Descendant · 3 generations on · 1 of its ownK151719 REVE134Kw Ear Lab, Inc. · 2015
- Descendant · 4 generations on · 0 of its ownK221168 Tinnitogram Signal GeneratorGoldenear Company, Inc. · 2023
Most influential descendants
Showing 4 of 4 · See all- K123450Phonak Tinnitus BalancePhonak, LLC · 2013 · cites it directly3descendants
- K133308Tinnitus SoundsupportOticon A/S · 2014 · 2 generations on2descendants
- K151719REVE134Kw Ear Lab, Inc. · 2015 · 3 generations on1descendant
- K221168Tinnitogram Signal GeneratorGoldenear Company, Inc. · 2023 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K974501 | Digital Tinnitus Masking System | Petroff Audio Technologies | 1998 | — |
| −3 | K030791 | Anmp (Acoustic Neuro Modulation Protocol) | Tinnitech, Ltd. | 2003 | — |
| −2 | K043274 | Neuromonics Tinnitus Treatment | Neuromonics Pty, Ltd. | 2005 | — |
| −1 | K080955 | Zen Program (Mind 440 Hearing Aid) | Widex Hearing Aid Co., Inc. | 2008 | — |
| 0 (this device) | K110973 | IE-Zen (in Clear Series Hearing Aid) | Widex USA | 2011 | — |
| +1 | K123450 | Phonak Tinnitus Balance | Phonak, LLC | 2013 | — |
| +2 | K133308 | Tinnitus Soundsupport | Oticon A/S | 2014 | — |
| +3 | K151719 | REVE134 | Kw Ear Lab, Inc. | 2015 | — |
| +4 | 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 |
|---|---|---|
| 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K101699 | WidexLink in CLEAR440 Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…Denmark Reason for Submission Inclusion of JE-Zen in CLEAR series hearing aids Marketed Devices with K101699 for WidexLink in CLEAR440 Substantial Equivalence K080955 Zen program in Widex mind440… | |
| * | K080955 | Zen Program (Mind 440 Hearing Aid)Summary page 1…CLEAR series hearing aids Marketed Devices with K101699 for WidexLink in CLEAR440 Substantial Equivalence K080955 Zen program in Widex mind440 12 5… | 2008 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123450 | Phonak Tinnitus Balance | 2013 | 3 |
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 13 years and passes through 5 companies; a new generation was cleared every 3.4 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K123450 (Phonak, LLC, 2013) has gone furthest, with 3 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. 2011, 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 IE-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 programmed 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/K110973 · printed Nov 4, 2026
Cite this page
510(k) Report. “K110973: IE-Zen (in Clear Series Hearing Aid).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K110973
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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