# K161331: HyperSound Tinnitus Module

- Pathway: 510(k) (Traditional)
- Applicant: Turtle Beach Corporation
- Decided: Aug 23, 2016 after 103 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). 8 ancestors in all.
No later device cites it as a predicate yet.
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 4.
- K111293: Soundcure Serenade Tinnitus Treatment System, Soundcure, Inc. (2011) Summary page 4.

## Indications for use
The HyperSound Tinnitus Module is indicated for patient home use in the temporary relief of tinnitus symptoms. The device is available in HyperSound Clear 500P audio systems to generate and deliver personalized sound output to tinnitus patients with or without hearing loss and with or without hearing aids. Any fitting of the device must be done by a hearing care professional. The target population is primarily adults (18 years or older).

Source page: https://510kreport.com/device/K161331
Methodology: https://510kreport.com/methodology