Cleared Traditional

MIRACLE - EAR (ITE/ITC/CIC)

K964419 · Miracle-Ear, Inc. · Ear, Nose, Throat

Feb 1997

Decision

126d

Days

Class 1

Risk

About This 510(k) Submission

K964419 is an FDA 510(k) clearance for the MIRACLE - EAR (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 February 4, 1997, 126 days after receiving the submission on October 1, 1996. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K964419 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 01, 1996
Decision Date	February 04, 1997
Days to Decision	126 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.