# K982683: Telex Select 1-40 with Adaptive Compression

- Pathway: 510(k) (Traditional)
- Applicant: Telex Communications, Inc.
- Decided: Oct 6, 1998 after 67 days
- Product code: EPF (Hearing Aid, Group And Auditory Trainer)
- Device class: 2
- Regulation: 21 CFR 874.3320
- 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 K913495 (1991). 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)
- K961143: Telex Select 2-40 with Adaptive Compression S2-40, Telex Communications, Inc. (1996) Summary page 1.

## Indications for use
The indication for use of the air conduction hearing aids is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following categories: slight, mild, moderate, and severe; high frequency, gradually sloping, reverse slope, and flat. The Telex Select 1-40 BTE FM System is best suited for students of middle school age and older who have a moderate to profound hearing loss. It may be appealing to older students that have rejected FM amplification because of the stigma associated with body-worn auditory trainers.

Source page: https://510kreport.com/device/K982683
Methodology: https://510kreport.com/methodology