Cleared Traditional

MIRACLE-EAR OR AUDIOTONE

K964669 · Miracle-Ear, Inc. · Ear, Nose, Throat

Dec 1996

Decision

35d

Days

Class 1

Risk

About This 510(k) Submission

K964669 is an FDA 510(k) clearance for the MIRACLE-EAR OR 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 26, 1996, 35 days after receiving the submission on November 21, 1996. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K964669 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 21, 1996
Decision Date	December 26, 1996
Days to Decision	35 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.