# K150171: Tinnitus Sound Generator Module

- Pathway: 510(k) (Special)
- Applicant: Gn Resound A/S
- Decided: May 14, 2015 after 108 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.
3 later devices descend from it; 1 cites it directly.
0 of 11 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.

## Most influential descendants
- K181586: Tinnitus Sound Generator Module (2018), 2 descendants of its own
- K180495: Tinnitus Sound Generator Module (2018), 1 descendant of its own
- K193303: Tinnitus Sound Generator Module (2020), 0 descendants of its own

## Indications for use
The Tinnitus Sound Generator Module is a tool to generate sounds to be used in a Tinnitus Management Program to relieve patients suffering from Tinnitus. The target population is primarily the adult population over 18 years of age. This product may also be used with children 5 years of age or older.

Source page: https://510kreport.com/device/K150171
Methodology: https://510kreport.com/methodology