# K971605: Resound ED4 Personal Hearing System W/Remote Control Option

- Pathway: 510(k) (Traditional)
- Applicant: Resound Corp.
- Decided: Jul 3, 1997 after 63 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 K951379 (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)
- K951379: Resound Personal Hearing System Models ED3A & ED3A/S W/Remonte Control Option, Resound Corp. (1995) Summary page 1.

## Indications for use
The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following categories: Severity: Slight, Mild, Moderate, Severe. Configuration: High Frequency, Gradually Sloping, Reverse Slope, Flat. Other: Low tolerance to loudness.

Source page: https://510kreport.com/device/K971605
Methodology: https://510kreport.com/methodology