# K130937: Wave 2G, Soul

- Pathway: 510(k) (Traditional)
- Applicant: Hansaton Akustik GmbH
- Decided: Jan 3, 2014 after 274 days
- Product code: KLW (Masker, Tinnitus)
- Device class: 2
- Regulation: 21 CFR 874.3400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K003558 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003558: Tci Combi (Tinnitus Control Instrument Combination), Siemens Hearing Instruments, Inc. (2001) Summary page 2.
- K003559: Tci (Tinnitus Control Instrument), Siemens Hearing Instruments, Inc. (2001) Summary page 2.
- K011366: Custom Tci-Combi (Tinnitus Control Instrument Combination), Siemens Hearing Instruments, Inc. (2001) Summary page 2.

## Cited in the summary but 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.

## Indications for use
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.

Source page: https://510kreport.com/device/K130937
Methodology: https://510kreport.com/methodology