Cleared Traditional

A-ZILICONE

K905555 · Oticon Corp. · Ear, Nose, Throat

Jul 1992

Decision

573d

Days

Class 1

Risk

About This 510(k) Submission

K905555 is an FDA 510(k) clearance for the A-ZILICONE, 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 6, 1992, 573 days after receiving the submission on December 11, 1990. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K905555 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 11, 1990
Decision Date	July 06, 1992
Days to Decision	573 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.