# K984243: Telex Tinnitus-Companion

- Pathway: 510(k) (Traditional)
- Applicant: Telex Communications, Inc.
- Decided: Jan 21, 1999 after 55 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: 2 generations back to K940667 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963838: Starkey TM Air Conduction Tinnitus Masker, Starkey Laboratories, Inc. (1996) Summary page 1.

## Indications for use
The indication for use of the tinnitus masker in this submission is for use in treatment and control of tinnitus.

Source page: https://510kreport.com/device/K984243
Methodology: https://510kreport.com/methodology