Cleared Traditional

HEARING AID (ALL-IN-THE-EAR)

K953960 · Audina Hearing Instrument · Ear, Nose, Throat

Sep 1995

Decision

21d

Days

Class 1

Risk

About This 510(k) Submission

K953960 is an FDA 510(k) clearance for the HEARING AID (ALL-IN-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 September 12, 1995, 21 days after receiving the submission on August 22, 1995. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K953960 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 22, 1995
Decision Date	September 12, 1995
Days to Decision	21 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.