Cleared Traditional

AUDIOTONE MODEL A-54

K941121 · Miracle-Ear, Inc. · Ear, Nose, Throat

May 1994

Decision

64d

Days

Class 1

Risk

About This 510(k) Submission

K941121 is an FDA 510(k) clearance for the AUDIOTONE MODEL A-54, a Hearing Aid, Air-conduction, Prescription (Class I — General Controls, product code ESD), submitted by Miracle-Ear, Inc. (Golden Valley, US). The FDA issued a Cleared decision on May 12, 1994, 64 days after receiving the submission on March 9, 1994. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K941121 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 09, 1994
Decision Date	May 12, 1994
Days to Decision	64 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.