Cleared Traditional

MIRACLE-EAR MODEL PM1/PM2 PROGRAMMABLE HEARING AID

K950693 · Miracle-Ear, Inc. · Ear, Nose, Throat

Mar 1995

Decision

45d

Days

Class 1

Risk

About This 510(k) Submission

K950693 is an FDA 510(k) clearance for the MIRACLE-EAR MODEL PM1/PM2 PROGRAMMABLE HEARING AID, 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 March 31, 1995, 45 days after receiving the submission on February 14, 1995. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K950693 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 14, 1995
Decision Date	March 31, 1995
Days to Decision	45 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.