# K970262: Multi-Channel Compression Bte (SD)

- Pathway: 510(k) (Traditional)
- Applicant: Miracle-Ear, Inc.
- Decided: Mar 31, 1997 after 67 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: 3 generations back to K954941 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964530: Dahlberg Hearing Aid with Multi-Channel Compression Circuit, Miracle-Ear, Inc. (1996) Summary page 1.

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

Source page: https://510kreport.com/device/K970262
Methodology: https://510kreport.com/methodology