# K963519: Euroline a-675 Seris

- Pathway: 510(k) (Traditional)
- Applicant: Starkey Laboratories, Inc.
- Decided: Sep 27, 1996 after 24 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 K940978 (1994). 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)
- K960494: Euroline A312 Series of Behind the Ear Air Conduction Hearing Aids, Starkey Laboratories, Inc. (1996) Summary page 1.
- (no number) Starkey Laboratories Euroline A-13 Series BTE Hearing aids: named in the summary without a submission number

## Indications for use
To assist in compensating for hearing loss by amplifying sound as it comes near the ear.

Source page: https://510kreport.com/device/K963519
Methodology: https://510kreport.com/methodology