Cleared Traditional

EUROLINE A312 SERIES OF BEHIND THE EAR AIR CONDUCTION HEARING AIDS

K960494 · Starkey Laboratories, Inc. · Ear, Nose, Throat

Mar 1996

Decision

31d

Days

Class 1

Risk

About This 510(k) Submission

K960494 is an FDA 510(k) clearance for the EUROLINE A312 SERIES OF BEHIND THE EAR AIR CONDUCTION HEARING AIDS, a Hearing Aid, Air-conduction, Prescription (Class I — General Controls, product code ESD), submitted by Starkey Laboratories, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on March 1, 1996, 31 days after receiving the submission on January 30, 1996. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K960494 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 30, 1996
Decision Date	March 01, 1996
Days to Decision	31 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF

Device Classification

Product Code	ESD — Hearing Aid, Air-conduction, Prescription
Device Class	Class I — General Controls
CFR Regulation	21 CFR 874.3300
Definition	An Air-conduction Hearing Aid Is A Wearable Sound Amplifying Device Intended To Compensate For Impaired Hearing That Conducts Sound To The Ear Through The Air. This Is A Prescription Hearing Aid.