Cleared Traditional

MODEL AUDINA ITE HEATING AID

K897024 · Audina Hearing Instrument · Ear, Nose, Throat

Apr 1990

Decision

120d

Days

Class 1

Risk

About This 510(k) Submission

K897024 is an FDA 510(k) clearance for the MODEL AUDINA ITE HEATING 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 April 18, 1990, 120 days after receiving the submission on December 19, 1989. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K897024 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 19, 1989
Decision Date	April 18, 1990
Days to Decision	120 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	—

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.