510(k) · Cleared
ClearedPhonak Tinnitus Balance
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Phonak, LLC · KLW Masker, Tinnitus
Cleared on Feb 11, 2013 as substantially equivalent to K110932 (Gn Resound A/S, 2011) and 2 other predicates after a 94-day review. Its family tree reaches back 5 generations to 1998. 3 later devices descend from it.
- Decided
- Feb 11, 2013
- Review
- 94 days
- Class
- Class II
- Product code
- KLW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K974501 (1998). 11 ancestors in all. 3 later devices descend 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 deviceK123450 Phonak Tinnitus BalancePhonak, LLC · 2013
- Descendant · cites it directly · 2 of its ownK133308 Tinnitus SoundsupportOticon A/S · 2014
- Descendant · 2 generations on · 1 of its ownK151719 REVE134Kw Ear Lab, Inc. · 2015
- Descendant · 3 generations on · 0 of its ownK221168 Tinnitogram Signal GeneratorGoldenear Company, Inc. · 2023
Most influential descendants
Showing 3 of 3 · See allView 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) | K123450 | Phonak Tinnitus Balance | Phonak, LLC | 2013 | — |
| +1 | K133308 | Tinnitus Soundsupport | Oticon A/S | 2014 | — |
| +2 | K151719 | REVE134 | Kw Ear Lab, Inc. | 2015 | — |
| +3 | K221168 | Tinnitogram Signal Generator | Goldenear Company, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 3 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K110932 | Tinnitus Sound Generator ModuleSummary page 1…2013 Device Name: Phonak Tinnitus Balance software feature Classification Name: Tinnitus Masker Product Code: KLW Predicate Devices: K110932 Tinnitus Sound Generator Module, GN ReSound A/S K110973 lE-Zen (in CLEAR series hea… | 2011 |
| * | K110973 | IE-Zen (in Clear Series Hearing Aid)Summary page 1…Tinnitus Masker Product Code: KLW Predicate Devices: K110932 Tinnitus Sound Generator Module, GN ReSound A/S K110973 lE-Zen (in CLEAR series hearing aid), Widex USA K003558 TCI-Combi, Siemens Hearing… | 2011 |
| * | K003558 | Tci Combi (Tinnitus Control Instrument Combination)Summary page 1…Tinnitus Sound Generator Module, GN ReSound A/S K110973 lE-Zen (in CLEAR series hearing aid), Widex USA K003558 TCI-Combi, Siemens Hearing Instruments Descrip~tion of Device The Tinnitus Balance software feature isa broadband noi… | 2001 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133308 | Tinnitus Soundsupport | 2014 | 2 |
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 15 years and passes through 5 companies; a new generation was cleared every 3.1 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K133308 (Oticon A/S, 2014) has gone furthest, with 2 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. 2013, 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 target group for the Phonak Tinnitus Balance software feature are adults 18 years of age or older with tinnitus who also desire amplification. The Tinnitus Balance software feature and accompanying hearing aid amplification is fit by a licensed hearing healthcare professional (audiologist, hearing aid specialist, otolaryngologist) familiar with the diagnosis and management of tinnitus. Phonak hearing aids provide amplification to address…
Read the full statement (170 words)
The target group for the Phonak Tinnitus Balance software feature are adults 18 years of age or older with tinnitus who also desire amplification.
The Tinnitus Balance software feature and accompanying hearing aid amplification is fit by a licensed hearing healthcare professional (audiologist, hearing aid specialist, otolaryngologist) familiar with the diagnosis and management of tinnitus. Phonak hearing aids provide amplification to address sensorineural, conductive, or mixed hearing losses. Depending on the specific model, Phonak hearing aids cover fitting ranges from mild to profound hearing losses.
Before being fit with Tinnitus Balance, individuals presenting with tinnitus should be assessed by a licensed ear physician to confirm the source of their tinnitus is not due to any of the following medical conditions:
*Visible congenital or traumatic deformity of the ear
*Any active drainage from the ear within the previous 90 days
*Sudden hearing loss within the previous 90 days
*Acute or chronic dizziness
*Unilateral hearing loss of sudden or recent onset within the previous 90 days
*Pain or discomfort in the ear
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123450 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123450: Phonak Tinnitus Balance.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123450
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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