Cleared Traditional

MIRACLE EAR AND AUDIOTONE

K954941 · Miracle-Ear, Inc. · Ear, Nose, Throat

Dec 1995

Decision

53d

Days

Class 1

Risk

About This 510(k) Submission

K954941 is an FDA 510(k) clearance for the MIRACLE EAR AND AUDIOTONE, 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 December 22, 1995, 53 days after receiving the submission on October 30, 1995. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K954941 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 30, 1995
Decision Date	December 22, 1995
Days to Decision	53 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.