# K964115: Resound CC4 Personal Hearing System

- Pathway: 510(k) (Traditional)
- Applicant: Resound Corp.
- Decided: Nov 4, 1996 after 20 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 K951067 (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)
- K951067: Resound ED4-C Canal Personal Hearing System W/Remote Control Option (Resound PHS ED4-C), Resound Corp. (1995) Summary page 1.

## Indications for use
This air-conduction hearing instrument is 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 moderate.

Source page: https://510kreport.com/device/K964115
Methodology: https://510kreport.com/methodology