Cleared Traditional

BTE HEARING AID OTICON MODEL E38P

K874380 · Oticon Corp. · Ear, Nose, Throat

Dec 1987

Decision

64d

Days

Class 1

Risk

About This 510(k) Submission

K874380 is an FDA 510(k) clearance for the BTE HEARING AID OTICON MODEL E38P, 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 29, 1987, 64 days after receiving the submission on October 26, 1987. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K874380 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 26, 1987
Decision Date	December 29, 1987
Days to Decision	64 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.