Cleared Traditional

STARKEY CE-8 TML, STARKEY CE-8 TMC AIR CONDUCTION HEARING AID

K940667 · Starkey Laboratories, Inc. · Ear, Nose, Throat

Aug 1994

Decision

174d

Days

Class 1

Risk

About This 510(k) Submission

K940667 is an FDA 510(k) clearance for the STARKEY CE-8 TML, STARKEY CE-8 TMC AIR CONDUCTION 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 August 9, 1994, 174 days after receiving the submission on February 16, 1994. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K940667 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 16, 1994
Decision Date	August 09, 1994
Days to Decision	174 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.