Cleared Traditional

AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EAR

K964816 · Audina Hearing Instrument · Ear, Nose, Throat

Jan 1997

Decision

49d

Days

Class 1

Risk

About This 510(k) Submission

K964816 is an FDA 510(k) clearance for the AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EAR, a Hearing Aid, Air-conduction, Prescription (Class I — General Controls, product code ESD), submitted by Audina Hearing Instrument (Longwood, US). The FDA issued a Cleared decision on January 17, 1997, 49 days after receiving the submission on November 29, 1996. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K964816 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 29, 1996
Decision Date	January 17, 1997
Days to Decision	49 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Statement

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.