# K970215: Audallion II Hearing System

- Pathway: 510(k) (Traditional)
- Applicant: Resound Corp.
- Decided: Mar 31, 1997 after 69 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: 2 generations back to K912665 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964557: Resound BT4 Personal Hearing System W/Remote Control Option, Resound Corp. (1996) Summary page 1.

## Indications for use
This air-conduction behind-the-ear hearing instrument with body-worn processor 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 severe.

Source page: https://510kreport.com/device/K970215
Methodology: https://510kreport.com/methodology