Cleared Traditional

BEHIND-THE-EAR HEARING AID

K930271 · Audina Hearing Instrument · Ear, Nose, Throat

Mar 1993

Decision

58d

Days

Class 1

Risk

About This 510(k) Submission

K930271 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 (Longwood, US). The FDA issued a Cleared decision on March 18, 1993, 58 days after receiving the submission on January 19, 1993. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K930271 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 19, 1993
Decision Date	March 18, 1993
Days to Decision	58 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.