Cleared Traditional

OTICAON BTE MODEL E34P

K904673 · Oticon Corp. · Ear, Nose, Throat

Nov 1990

Decision

20d

Days

Class 1

Risk

About This 510(k) Submission

K904673 is an FDA 510(k) clearance for the OTICAON BTE MODEL E34P, 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 November 1, 1990, 20 days after receiving the submission on October 12, 1990. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K904673 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 12, 1990
Decision Date	November 01, 1990
Days to Decision	20 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.