Cleared Traditional

MIRACLE EAR & AUDIOTONE MODEL ITE/ITC/CIC

K960804 · Miracle-Ear, Inc. · Ear, Nose, Throat

Apr 1996

Decision

37d

Days

Class 1

Risk

About This 510(k) Submission

K960804 is an FDA 510(k) clearance for the MIRACLE EAR & AUDIOTONE MODEL ITE/ITC/CIC, 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 April 5, 1996, 37 days after receiving the submission on February 28, 1996. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K960804 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 28, 1996
Decision Date	April 05, 1996
Days to Decision	37 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.