# K111293: Soundcure Serenade Tinnitus Treatment System

- Pathway: 510(k) (Traditional)
- Applicant: Soundcure, Inc.
- Decided: Aug 24, 2011 after 110 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: 4 generations back to K974501 (1998). 6 ancestors in all.
6 later devices descend from it; 5 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073636: Tinnitus Sound Generator Module, Gn Resound A/S (2008) Summary page 1.

## Most influential descendants
- K150065: SoundCure Serenade Tinnitus Treatment System (2015), 2 descendants of its own
- K161562: Sound Options Tinnitus Treatment (2016), 1 descendant of its own
- K140845: Levo Tinnitus Masking Software Device (2014), 1 descendant of its own
- K233435: Peace N Quiet (0.7.0) (2024), 0 descendants of its own
- K163094: TinniLogic Mobile Tinnitus Management Device (2017), 0 descendants of its own

## Indications for use
The SoundCure Serenade Tinnitus Treatment System is indicated for use in the temporary relief of tinnitus symptoms. The device is a tool to generate customized sounds to relieve patients suffering from tinnitus and can be used in a tinnitus management program. The target population is adults (18 years or older). This is a medical device and should only be used with the advice of a physician, audiologist or other hearing healthcare professional.

Source page: https://510kreport.com/device/K111293
Methodology: https://510kreport.com/methodology