# K030180: Crescent Tinnitus Retaining Sound Generator

- Pathway: 510(k) (Traditional)
- Applicant: Starkey Laboratories, Inc.
- Decided: Sep 17, 2003 after 243 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Crescent Sound Generator is an electronic, air-conduction broadband noise generator intended to generate noise of sufficient intensity and bandwidth to be used for tinnitus masking therapy. The Crescent Sound Generator is intended to be used by those individuals who experience tinnitus, and do not need or desire amplification. The intended use of this device includes it’s fitting by a qualified audiologist or other hearing healthcare professional familiar with the diagnosis and treatment of tinnitus. The target population is the adult population over 18 years of age.

Source page: https://510kreport.com/device/K030180
Methodology: https://510kreport.com/methodology