Cleared Traditional

CUSTOM ITE HEARING AID MODELS F AND L

K902353 · Oticon Corp. · Ear, Nose, Throat

Jun 1990

Decision

16d

Days

Class 1

Risk

About This 510(k) Submission

K902353 is an FDA 510(k) clearance for the CUSTOM ITE HEARING AID MODELS F AND L, 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 14, 1990, 16 days after receiving the submission on May 29, 1990. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K902353 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 29, 1990
Decision Date	June 14, 1990
Days to Decision	16 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.