510(k) · Cleared
ClearedMultiflex Tinnitus Technology
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Starkey Laboratories · KLW Masker, Tinnitus
Cleared on Oct 31, 2012 as substantially equivalent to K110932 (Gn Resound A/S, 2011) after a 42-day review. Its family tree reaches back 5 generations to 1998. 1 later device descends from it.
- Decided
- Oct 31, 2012
- Review
- 42 days
- Class
- Class II
- Product code
- KLW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K974501 (1998). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK974501 Digital Tinnitus Masking SystemPetroff Audio Technologies · 1998
- 4 generations backK030791 Anmp (Acoustic Neuro Modulation Protocol)Tinnitech, Ltd. · 2003
- 3 generations backK040330 QuiescenceSpectral Visualization & Development, Inc. · 2004
- 2 generations backK073636 Tinnitus Sound Generator ModuleGn Resound A/S · 2008
- 1 generation backK110932 Tinnitus Sound Generator ModuleGn Resound A/S · 2011
- This deviceK122876 Multiflex Tinnitus TechnologyStarkey Laboratories · 2012
- Descendant · cites it directly · 0 of its ownK201370 Multiflex Tinnitus TechnologyStarkey Laboratories, Inc. · 2020
Most influential descendants
Showing 1 of 1 · See all- K201370Multiflex Tinnitus TechnologyStarkey Laboratories, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K974501 | Digital Tinnitus Masking System | Petroff Audio Technologies | 1998 | — |
| −4 | K030791 | Anmp (Acoustic Neuro Modulation Protocol) | Tinnitech, Ltd. | 2003 | — |
| −3 | K040330 | Quiescence | Spectral Visualization & Development, Inc. | 2004 | — |
| −2 | K073636 | Tinnitus Sound Generator Module | Gn Resound A/S | 2008 | — |
| −1 | K110932 | Tinnitus Sound Generator Module | Gn Resound A/S | 2011 | — |
| 0 (this device) | K122876 | Multiflex Tinnitus Technology | Starkey Laboratories | 2012 | — |
| +1 | K201370 | Multiflex Tinnitus Technology | Starkey Laboratories, Inc. | 2020 | — |
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 |
|---|---|---|
| 2020 | 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? (1)
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 |
|---|---|---|---|
| * | K110932 | Tinnitus Sound Generator ModuleSummary page 1…cation Name: 21 CFR 874.3400 Tinnilus Masker Classification Panel: Ophthalmic and Ear, Nose, and Throat Division Product Code: KLW Predicate Device: K1 10932, GN Resound Tinnitus Sound Generator Module Device Description The Starkey Multiflex Tinnitus Technology Tm ' provides the he… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201370 | Multiflex Tinnitus Technology | 2020 | 0 |
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 14 years and passes through 5 companies; a new generation was cleared every 3.1 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K201370 (Starkey Laboratories, Inc., 2020) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K110932.
How does its category compare?
All KLW devicesKLW Masker, Tinnitus: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Multiflex Tinnitus Technologym is a tool to generate sounds to be used in a Tinnitus Management Program to relieve patients suffering from tinnitus. The target population is primarily the adult population over 18 years of age.
The Multiflex Tinnitus Technologym is targeted for healthcare professionals, which are treating patients suffering from tinnitus, as well as conventional hearing disorders. The fitting of the Multiflex Tinnitus Technology Mmust be done by a hearing professional participating in a Tinnitus Management Program.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122876 · printed Nov 5, 2026
Cite this page
510(k) Report. “K122876: Multiflex Tinnitus Technology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K122876
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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