# K964557: Resound BT4 Personal Hearing System W/Remote Control Option

- Pathway: 510(k) (Traditional)
- Applicant: Resound Corp.
- Decided: Nov 27, 1996 after 14 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 K912665 (1991). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912665: System BT W/Remote Control Option Hearing Aid, Resound Corp. (1991) Summary page 1.

## Most influential descendants
- K974257: Resound Digital 2000-BT W/Digital 2000-DF (Digital Programmer) (1997), 0 descendants of its own
- K970215: Audallion II Hearing System (1997), 0 descendants of its own

## Indications for use
This air-conduction behind-the-ear hearing instrument, intended to amplify sound pressure waves and transmit the signal to the external ear through the medium of air, is designed to compensate for hearing losses from mild to severe.

Source page: https://510kreport.com/device/K964557
Methodology: https://510kreport.com/methodology