Cleared Traditional

INSOUND XT SERIES HEARING AID

K021867 · Insound Medical, Inc. · Ear, Nose, Throat

Nov 2002

Decision

166d

Days

Class 1

Risk

About This 510(k) Submission

K021867 is an FDA 510(k) clearance for the INSOUND XT SERIES HEARING AID, a Hearing Aid, Air-conduction, Prescription (Class I — General Controls, product code ESD), submitted by Insound Medical, Inc. (Newark, US). The FDA issued a Cleared decision on November 19, 2002, 166 days after receiving the submission on June 6, 2002. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K021867 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 06, 2002
Decision Date	November 19, 2002
Days to Decision	166 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF

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.