Cleared Traditional

AIR CONDUCTION HEARING AID

K944520 · Unitron Industries, Inc. · Ear, Nose, Throat

Dec 1994

Decision

102d

Days

Class 1

Risk

About This 510(k) Submission

K944520 is an FDA 510(k) clearance for the AIR CONDUCTION HEARING AID, a Hearing Aid, Air-conduction, Prescription (Class I — General Controls, product code ESD), submitted by Unitron Industries, Inc. (Port Huron, US). The FDA issued a Cleared decision on December 27, 1994, 102 days after receiving the submission on September 16, 1994. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K944520 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 16, 1994
Decision Date	December 27, 1994
Days to Decision	102 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.