Cleared Traditional

BTE HEARING AID PERSONIC 425

K923491 · Oticon Corp. · Ear, Nose, Throat

Aug 1992

Decision

23d

Days

Class 1

Risk

About This 510(k) Submission

K923491 is an FDA 510(k) clearance for the BTE HEARING AID PERSONIC 425, 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 August 6, 1992, 23 days after receiving the submission on July 14, 1992. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K923491 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 14, 1992
Decision Date	August 06, 1992
Days to Decision	23 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Statement

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.