Cleared Traditional

OTICON MODEL I50 IN-THE-EAR HEARING AID

K874744 · Oticon Corp. · Ear, Nose, Throat

Dec 1987

Decision

22d

Days

Class 1

Risk

About This 510(k) Submission

K874744 is an FDA 510(k) clearance for the OTICON MODEL I50 IN-THE-EAR HEARING AID, 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 December 10, 1987, 22 days after receiving the submission on November 18, 1987. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K874744 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 18, 1987
Decision Date	December 10, 1987
Days to Decision	22 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.