# K260614: Tinnitus Therapy

- Pathway: 510(k) (Special)
- Applicant: Sivantos GmbH
- Decided: Jun 10, 2026 after 105 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). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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 5.

## Indications for use
The Tinnitus Therapy feature is intended to output noise of sufficient intensity and bandwidth to be used for tinnitus habituation therapy and is also suitable for tinnitus masking therapy. Tinnitus Therapy feature is intended to be used by those individuals who experience tinnitus and desire amplification. This device is fit by a qualified audiologist or other hearing healthcare professional familiar with the diagnosis of tinnitus and subsequent rehabilitation therapy. The target population is primarily the adult population over 18 years of age. The target group for this product includes individuals reporting tinnitus who do need amplification. This product may also be used with children 5 years of age or older.

Source page: https://510kreport.com/device/K260614
Methodology: https://510kreport.com/methodology