# K130494: Unitron Tinnitus Masker Feature

- Pathway: 510(k) (Abbreviated)
- Applicant: Unitron Hearing
- Decided: May 7, 2013 after 70 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: 5 generations back to K974501 (1998). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110932: Tinnitus Sound Generator Module, Gn Resound A/S (2011) Summary page 1.

## Most influential descendants
- K150014: Serenity (2015), 0 descendants of its own

## Indications for use
Unitron's tinnitus masker is a broadband sound generator available in Unitron Era hearing aid platforms. It provides a means of sound enrichment therapy that can be used as part of a personalized tinnitus management program to provide temporary relief from tinnitus. Tinnitus masker is intended for adults 18 years of age or older who have both hearing loss and tinnitus. The tinnitus masker within the air conduction hearing instrument is fitted by a hearing health care professional familiar with diagnosis and management of tinnitus. The underlying principle of sound enrichment is to provide supplementary noise stimulation which can help defocus your attention from your tinnitus and avoid negative reactions. Sound enrichment coupled with instructional counseling, is an established approach to managing tinnitus.

Source page: https://510kreport.com/device/K130494
Methodology: https://510kreport.com/methodology