Cleared Traditional

BEHIND THE EAR HEARING AID

K936190 · Audina Hearing Instrument · Ear, Nose, Throat

Apr 1994

Decision

98d

Days

Class 1

Risk

About This 510(k) Submission

K936190 is an FDA 510(k) clearance for the BEHIND THE EAR HEARING AID, a Hearing Aid, Air-conduction, Prescription (Class I — General Controls, product code ESD), submitted by Audina Hearing Instrument (Casselberry, US). The FDA issued a Cleared decision on April 4, 1994, 98 days after receiving the submission on December 27, 1993. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K936190 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 27, 1993
Decision Date	April 04, 1994
Days to Decision	98 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.