510(k) · Cleared
ClearedEvok 900 Series Hearing Aid/Tinnitus Masker Option Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Magnatone Hearing Aid Corp. Dba Persona Medical · KLW Masker, Tinnitus
Cleared on Dec 22, 2010 as substantially equivalent to K974751 (General Hearing Instruments, Inc., 1998) and 1 other predicate after a 386-day review. Its family tree reaches back 4 generations to 1998.
- Decided
- Dec 22, 2010
- Review
- 386 days
- Class
- Class II
- Product code
- KLW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K974501 (1998). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK974501 Digital Tinnitus Masking SystemPetroff Audio Technologies · 1998
- 3 generations backK030791 Anmp (Acoustic Neuro Modulation Protocol)Tinnitech, Ltd. · 2003
- 2 generations backK040330 QuiescenceSpectral Visualization & Development, Inc. · 2004
- 1 generation backK073636 Tinnitus Sound Generator ModuleGn Resound A/S · 2008
- This deviceK093715 Evok 900 Series Hearing Aid/Tinnitus Masker Option DeviceMagnatone Hearing Aid Corp. Dba Persona Medical · 2010
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 | K040330 | Quiescence | Spectral Visualization & Development, Inc. | 2004 | — |
| −1 | K073636 | Tinnitus Sound Generator Module | Gn Resound A/S | 2008 | — |
| 0 (this device) | K093715 | Evok 900 Series Hearing Aid/Tinnitus Masker Option Device | Magnatone Hearing Aid Corp. Dba Persona Medical | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 2 | 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 |
|---|---|---|---|
| * | K974751 | Tranquil Tri-OE, Tranquil Tri-Coe, Tranquil Tri-CicSummary page 2…ation Name: Tinnitus Masker/Hearing Aid Regulatory Class: Class If/Class I Product Code: KLW 5 10(k) Number: K974751 Manufacturer: GN Resound 8001 Bloomington Freeway,… | 1998 |
| * | K073636 | Tinnitus Sound Generator ModuleSummary page 2…lation Name: Tinnitus Masker/Hearing Aid Regulatory Class: Class IIClass I Product Code: KLW 5 10(k) Number: K073636 Device Description: Our devices are a combination of a hearing aid and a tinnitus masker in the same instrument.… | 2008 |
| * | — | GN Resound Live TS BTE, OTE and RIB (RIC) products Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
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 12 years and passes through 5 companies; a new generation was cleared every 3.9 years on median.
- None of the 7 ancestors has a recall.
- 2 other devices also cite its predicate K974751.
How does its category compare?
All KLW devicesKLW Masker, Tinnitus: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Evok series is designed for use in sound therapy for tinnitus retraining therapy, masking, or other recognized forms of tinnitus treatment. Sound therapy should be used in concert with counseling from a physician, an audiologist or other qualified tinnitus specialists. The target population for this product is primarily the adult population 18 years of age and older. The target group for this product includes individuals reporting tinnitus who can…
Read the full statement (226 words)
The Evok series is designed for use in sound therapy for tinnitus retraining therapy, masking, or other recognized forms of tinnitus treatment. Sound therapy should be used in concert with counseling from a physician, an audiologist or other qualified tinnitus specialists.
The target population for this product is primarily the adult population 18 years of age and older. The target group for this product includes individuals reporting tinnitus who can also benefit from an air conduction hearing aid.
NOTE: The Evok 900 series Tinnitus Masker Devices are targeted primarily to the adult population over 18 years old. Our User Guide does state this but it also has a statement that reads; "a child with a hearing loss should be directed to an Audiologist for evaluation and rehabilitation". This is not meant to be a contradiction considering the user guide is generic in the general information supplied to the end user.
As part of a Tinnitus Management Program, we suggest the following recommendations applicable to clinical settings for all the devices listed above;
The Tinnitus Management treatment should include evaluation and recommendations done by a qualified audiologist, otorhinolaryngologists or other licensed hearing healthcare professional. Since tinnitus can be associated with a number of auditory conditions, the audiologic evaluation can yield extensive information regarding the possible cause for the tinnitus and options for a successful Tinnitus Management treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093715 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093715: Evok 900 Series Hearing Aid/Tinnitus Masker Option Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093715
Report an extraction error
Are you the manufacturer?
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