Cleared Traditional

MIRACLE-EAR ITE DIGITAL

K972346 · Miracle-Ear, Inc. · Ear, Nose, Throat

Jul 1997

Decision

29d

Days

Class 1

Risk

About This 510(k) Submission

K972346 is an FDA 510(k) clearance for the MIRACLE-EAR ITE DIGITAL, 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 July 23, 1997, 29 days after receiving the submission on June 24, 1997. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K972346 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 24, 1997
Decision Date	July 23, 1997
Days to Decision	29 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.