Cleared Traditional

UV CURED METHYL METHACRYLATE HEARING AID SHELL MATERIALS

K943960 · Miracle-Ear, Inc. · Ear, Nose, Throat

Oct 1994

Decision

66d

Days

Class 1

Risk

About This 510(k) Submission

K943960 is an FDA 510(k) clearance for the UV CURED METHYL METHACRYLATE HEARING AID SHELL MATERIALS, 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 October 20, 1994, 66 days after receiving the submission on August 15, 1994. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K943960 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 15, 1994
Decision Date	October 20, 1994
Days to Decision	66 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.