# K963915: Telex in-the-Ear Custom Hearing Aid with Threshold Compression

- Pathway: 510(k) (Traditional)
- Applicant: Telex Communications, Inc.
- Decided: Nov 8, 1996 after 39 days
- Product code: ESD (Hearing Aid, Air-Conduction, Prescription)
- Device class: 1
- Regulation: 21 CFR 874.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K922066 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922066: Telex Model 28A Ite Custom Hearing Aid, Telex Communications, Inc. (1992) Summary page 1.

## Indications for use
to amplify and transmit sound to the ear.

Source page: https://510kreport.com/device/K963915
Methodology: https://510kreport.com/methodology