Cleared Traditional

CUSTOM IN-THE-CANAL HEARING AID MODEL: I52A

K890703 · Oticon Corp. · Ear, Nose, Throat

Mar 1989

Decision

35d

Days

Class 1

Risk

About This 510(k) Submission

K890703 is an FDA 510(k) clearance for the CUSTOM IN-THE-CANAL HEARING AID MODEL: I52A, a Hearing Aid, Air-conduction, Prescription (Class I — General Controls, product code ESD), submitted by Oticon Corp. (Somerset, US). The FDA issued a Cleared decision on March 17, 1989, 35 days after receiving the submission on February 10, 1989. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K890703 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 10, 1989
Decision Date	March 17, 1989
Days to Decision	35 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.