# K963995: Starkey MA-3 Air Conduction Combination Hearing Aid/Tinnitus Masker

- Pathway: 510(k) (Traditional)
- Applicant: Starkey Laboratories, Inc.
- Decided: Nov 26, 1996 after 53 days
- Product code: KLW (Masker, Tinnitus)
- Device class: 2
- Regulation: 21 CFR 874.3400
- 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 K940667 (1994). 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)
- K940667: Starkey CE-8 TML, Starkey CE-8 TMC Air Conduction Hearing Aid, Starkey Laboratories, Inc. (1994) Summary page 1.

## Indications for use
To assist in compensating for hearing loss by amplifying sound as it comes into the ear and to generate a pleasant white noise stimulus to aid in masking the user's tinnitus (or ringing in the ears)

Source page: https://510kreport.com/device/K963995
Methodology: https://510kreport.com/methodology