# K180495: Tinnitus Sound Generator Module

- Pathway: 510(k) (Traditional)
- Applicant: GN Hearing A/S
- Decided: Nov 30, 2018 after 277 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: 7 generations back to K974501 (1998). 9 ancestors in all.
1 later device descends 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)
- K181586: Tinnitus Sound Generator Module, GN Hearing A/S (2018). Cleared while this submission was under review Summary page 4.

## Most influential descendants
- 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 temporarily 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. The Tinnitus Sound Generator module is targeted for healthcare professionals, which are treating patients suffering from Tinnitus, as well as conventional hearing disorders. The fitting of the Tinnitus Sound Generator module must be done by a hearing professional participating in a Tinnitus Management Program.

Source page: https://510kreport.com/device/K180495
Methodology: https://510kreport.com/methodology