# K161562: Sound Options Tinnitus Treatment

- Pathway: 510(k) (Traditional)
- Applicant: Sound Options Tinnitus Treatments, Inc.
- Decided: Sep 28, 2016 after 114 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: 6 generations back to K974501 (1998). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111293: Soundcure Serenade Tinnitus Treatment System, Soundcure, Inc. (2011) Summary page 5.
- K150065: SoundCure Serenade Tinnitus Treatment System, Soundcure, Inc. (2015) Summary page 5.

## Most influential descendants
- K233435: Peace N Quiet (0.7.0) (2024), 0 descendants of its own

## Indications for use
The device, Sound Options Tinnitus Treatment, version SO 2.0, is for the temporary relief of tinnitus symptoms. The device is a software application that embeds sounds and spectral content into music to relieve patients suffering from tinnitus and can be used as part of a tinnitus management program for adults 18 years and older. The device is for prescription use by a physician, audiologist or other healthcare professional.

Source page: https://510kreport.com/device/K161562
Methodology: https://510kreport.com/methodology