Cleared Traditional

OTICON BTE HEARING AID (BEHIND-THE-EAR), MODEL E44

K901292 · Oticon Corp. · Ear, Nose, Throat

Apr 1990

Decision

21d

Days

Class 1

Risk

About This 510(k) Submission

K901292 is an FDA 510(k) clearance for the OTICON BTE HEARING AID (BEHIND-THE-EAR), MODEL E44, 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 April 10, 1990, 21 days after receiving the submission on March 20, 1990. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K901292 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 20, 1990
Decision Date	April 10, 1990
Days to Decision	21 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.