Cleared Traditional

AURIS CIC

K943144 · General Hearing Instruments, Inc. · Ear, Nose, Throat

Jul 1994

Decision

21d

Days

Class 1

Risk

About This 510(k) Submission

K943144 is an FDA 510(k) clearance for the AURIS CIC, a Hearing Aid, Air-conduction, Prescription (Class I — General Controls, product code ESD), submitted by General Hearing Instruments, Inc. (New Orleans, US). The FDA issued a Cleared decision on July 20, 1994, 21 days after receiving the submission on June 29, 1994. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K943144 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 29, 1994
Decision Date	July 20, 1994
Days to Decision	21 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.