Cleared Traditional

STAR 42 PP SP STAR 42 DIGITALLY PROGRAMMABLE HEARING AID

K942594 · Starkey Laboratories, Inc. · Ear, Nose, Throat

Jul 1994

Decision

34d

Days

Class 1

Risk

About This 510(k) Submission

K942594 is an FDA 510(k) clearance for the STAR 42 PP SP STAR 42 DIGITALLY PROGRAMMABLE HEARING AID, 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 July 5, 1994, 34 days after receiving the submission on June 1, 1994. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K942594 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 01, 1994
Decision Date	July 05, 1994
Days to Decision	34 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.