# K073636: Tinnitus Sound Generator Module

- Pathway: 510(k) (Traditional)
- Applicant: Gn Resound A/S
- Decided: Mar 13, 2008 after 78 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: 3 generations back to K974501 (1998). 5 ancestors in all.
22 later devices descend from it; 4 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040330: Quiescence, Spectral Visualization & Development, Inc. (2004) Summary page 1.
- K003558: Tci Combi (Tinnitus Control Instrument Combination), Siemens Hearing Instruments, Inc. (2001) Summary page 1.

## Most influential descendants
- K110932: Tinnitus Sound Generator Module (2011), 13 descendants of its own
- K111293: Soundcure Serenade Tinnitus Treatment System (2011), 6 descendants of its own
- K150171: Tinnitus Sound Generator Module (2015), 3 descendants of its own
- K123450: Phonak Tinnitus Balance (2013), 3 descendants of its own
- K181586: Tinnitus Sound Generator Module (2018), 2 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 tinnitjs. 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 hearing professional participating in a tinnitus management program.

Source page: https://510kreport.com/device/K073636
Methodology: https://510kreport.com/methodology