Cleared Traditional

BEHIND-THE-EAR HEARING AID OTICON E40

K872372 · Oticon Corp. · Ear, Nose, Throat

Jul 1987

Decision

42d

Days

Class 1

Risk

About This 510(k) Submission

K872372 is an FDA 510(k) clearance for the BEHIND-THE-EAR HEARING AID OTICON E40, 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 July 31, 1987, 42 days after receiving the submission on June 19, 1987. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K872372 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 19, 1987
Decision Date	July 31, 1987
Days to Decision	42 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.