Cleared Traditional

BTE HEARING AID OTICON MODEL E30P

K872017 · Oticon Corp. · Ear, Nose, Throat

Jun 1987

Decision

13d

Days

Class 1

Risk

About This 510(k) Submission

K872017 is an FDA 510(k) clearance for the BTE HEARING AID OTICON MODEL E30P, 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 June 8, 1987, 13 days after receiving the submission on May 26, 1987. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K872017 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 26, 1987
Decision Date	June 08, 1987
Days to Decision	13 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.