Cleared Traditional

CUSTOM IN-THE-EAR HEARING AID OTICON MODEL: P

K902559 · Oticon Corp. · Ear, Nose, Throat

Jul 1990

Decision

28d

Days

Class 1

Risk

About This 510(k) Submission

K902559 is an FDA 510(k) clearance for the CUSTOM IN-THE-EAR HEARING AID OTICON MODEL: P, 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 9, 1990, 28 days after receiving the submission on June 11, 1990. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K902559 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 11, 1990
Decision Date	July 09, 1990
Days to Decision	28 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.