Cleared Traditional

OTICON HEARING AID MODEL I52

K874651 · Oticon Corp. · Ear, Nose, Throat

Jan 1988

Decision

67d

Days

Class 1

Risk

About This 510(k) Submission

K874651 is an FDA 510(k) clearance for the OTICON HEARING AID MODEL I52, 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 January 19, 1988, 67 days after receiving the submission on November 13, 1987. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K874651 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 13, 1987
Decision Date	January 19, 1988
Days to Decision	67 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.