Cleared Traditional

STARKEY MA-3 AIR CONDUCTION COMBINATION HEARING AID/TINNITUS MASKER

K963995 · Starkey Laboratories, Inc. · Ear, Nose, Throat

Nov 1996

Decision

53d

Days

Class 2

Risk

About This 510(k) Submission

K963995 is an FDA 510(k) clearance for the STARKEY MA-3 AIR CONDUCTION COMBINATION HEARING AID/TINNITUS MASKER, a Masker, Tinnitus (Class II — Special Controls, product code KLW), submitted by Starkey Laboratories, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on November 26, 1996, 53 days after receiving the submission on October 4, 1996. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3400.

Submission Details

510(k) Number	K963995 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 04, 1996
Decision Date	November 26, 1996
Days to Decision	53 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF