# K960680: Resound Personal Hearing Systems Edr Encore Series Models Edr-E, Edr-ES, Edr-EV, & Edr-P1

- Pathway: 510(k) (Traditional)
- Applicant: Resound Corp.
- Decided: Apr 10, 1996 after 50 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 K950319 (1995). 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)
- K950319: Resound (R) Personal Hearing System ED-3 Encore, Resound Corp. (1995) Summary page 1.

## Indications for use
These air-conduction hearing instruments are intended to amplify sound pressure waves and transmit the signal to the external ear through the medium of air to compensate for hearing losses from mild to moderately-severe.

Source page: https://510kreport.com/device/K960680
Methodology: https://510kreport.com/methodology