510(k) · Cleared
ClearedWave 2G, Soul
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hansaton Akustik GmbH · KLW Masker, Tinnitus
Cleared on Jan 3, 2014 as substantially equivalent to K003558 (Siemens Hearing Instruments, Inc., 2001) and 2 other predicates after a 274-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Jan 3, 2014
- Review
- 274 days
- Class
- Class II
- Product code
- KLW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K003558 (2001). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK003558 Tci Combi (Tinnitus Control Instrument Combination)Siemens Hearing Instruments, Inc. · 2001
- This deviceK130937 Wave 2G, SoulHansaton Akustik GmbH · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003558 | Tci Combi (Tinnitus Control Instrument Combination) | Siemens Hearing Instruments, Inc. | 2001 | — |
| 0 (this device) | K130937 | Wave 2G, Soul | Hansaton Akustik GmbH | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (4)
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 |
|---|---|---|---|
| * | K003558 | Tci Combi (Tinnitus Control Instrument Combination)Summary page 2…t intended for pediatric use. Predicate devices: 1. Device Trade Name: TCI Combi Applicant: Siemens Hearing Instruments 51 0(k) No.: K003558 2. Device Trade Name: TCI Applicant: Siemens Hearing Instruments 51 0(k) No.: K003559 3.… | 2001 |
| * | K003559 | Tci (Tinnitus Control Instrument)Summary page 2…earing Instruments 51 0(k) No.: K003558 2. Device Trade Name: TCI Applicant: Siemens Hearing Instruments 51 0(k) No.: K003559 3. Device Trade Name: Custom TCl Combi Applicant: Siemens Hearing Instruments 51 0(k) No.:… | 2001 |
| * | K011366 | Custom Tci-Combi (Tinnitus Control Instrument Combination)Summary page 2…ents 51 0(k) No.: K003559 3. Device Trade Name: Custom TCl Combi Applicant: Siemens Hearing Instruments 51 0(k) No.: K011366 4. Device Trade Name: WIDEXLINK IN CLEAR SERIES HEARING AIDS Applicant: Office Research in Clinical Ampl… | 2001 |
| Kept off the family tree | K101699 | Widexlink in Clear Series Hearing Aids 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 2…366 4. Device Trade Name: WIDEXLINK IN CLEAR SERIES HEARING AIDS Applicant: Office Research in Clinical Amplification 51 0(k) No.: K1 01 699 -2- noise generators generators and Pro… |
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?
- None of the 3 ancestors has a recall.
- 4 other devices also cite its predicate K003558.
How does its category compare?
All KLW devicesKLW Masker, Tinnitus: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Hansaton Tinnitus Maskers are air conduction broad band noise generators and hearing aids intended to output noise of sufficient intensity and bandwidth to be used for tinnitus habituation therapy and are suitable for tinnitus masking therapy. Optional, the Hansaton SOUL Tinnitus Maskers provide amplification, intended to be used by those individuals who experience tinnitus and desire amplification. Diagnosis and prescription of the tinnitus maskers…
Read the full statement (107 words)
The Hansaton Tinnitus Maskers are air conduction broad band noise generators and hearing aids intended to output noise of sufficient intensity and bandwidth to be used for tinnitus habituation therapy and are suitable for tinnitus masking therapy. Optional, the Hansaton SOUL Tinnitus Maskers provide amplification, intended to be used by those individuals who experience tinnitus and desire amplification. Diagnosis and prescription of the tinnitus maskers must be performed by hearing health specialists (e.g., ENT specialists, audiologists, or hearing system professionals) who are experienced in tinnitus management.
The target population is primarily the adult population over 18 years of age. The instruments are not intended for pediatric use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130937 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130937: Wave 2G, Soul.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130937
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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