Cleared Traditional

AURIS AE, AURIS TL, AURIS HS, AURIS AC, AURIS MM, AURIS COE, AURIS CIC

K971399 · General Hearing Instruments, Inc. · Ear, Nose, Throat

Jun 1997

Decision

59d

Days

Class 1

Risk

About This 510(k) Submission

K971399 is an FDA 510(k) clearance for the AURIS AE, AURIS TL, AURIS HS, AURIS AC, AURIS MM, AURIS COE, AURIS CIC, a Hearing Aid, Air-conduction, Prescription (Class I — General Controls, product code ESD), submitted by General Hearing Instruments, Inc. (Harahan, US). The FDA issued a Cleared decision on June 13, 1997, 59 days after receiving the submission on April 15, 1997. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K971399 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 15, 1997
Decision Date	June 13, 1997
Days to Decision	59 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.