# K132965: Solace Sound Generators

- Pathway: 510(k) (Abbreviated)
- Applicant: Amplisound Hearing Products & Services
- Decided: Mar 25, 2014 after 186 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). 12 ancestors in all.
No later device cites it as a predicate yet.
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.
- K982451: Ttcghi-T and TTCTN3-T-T, Tinnitus Treatment Centers, Inc. (1999) Summary page 1.

## Indications for use
Quell sound generators are designed for individuals who experience tinnitus. These devices generate a digitally controlled passive analog broad band noise from the circuit. The broad band noise is intended for use with tinnitus masking therapy. These devices are to be dispensed only by a doctor, licensed audiologist, or licensed hearing instrument specialist who are trained in the area of tinnitus treatment. BTE worn sound generators are one of several available sound stimuli means such as; computer generated audio, CD player, iPod, sound pillows, etc. Sound generators are dispensed to an adult population 18 years of age or above with specific instructions for their use.

Source page: https://510kreport.com/device/K132965
Methodology: https://510kreport.com/methodology