Cleared Traditional

MIRACLE EAR CONFIDANTE

K943825 · Miracle-Ear, Inc. · Ear, Nose, Throat

Sep 1994

Decision

47d

Days

Class 1

Risk

About This 510(k) Submission

K943825 is an FDA 510(k) clearance for the MIRACLE EAR CONFIDANTE, 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 September 21, 1994, 47 days after receiving the submission on August 5, 1994. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K943825 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 05, 1994
Decision Date	September 21, 1994
Days to Decision	47 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.