Cleared Traditional

TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)

K003558 · Siemens Hearing Instruments, Inc. · Ear, Nose, Throat

Apr 2001

Decision

158d

Days

Class 1

Risk

About This 510(k) Submission

K003558 is an FDA 510(k) clearance for the TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION), a Hearing Aid, Air-conduction, Prescription (Class I — General Controls, product code ESD), submitted by Siemens Hearing Instruments, Inc. (Piscataway, US). The FDA issued a Cleared decision on April 24, 2001, 158 days after receiving the submission on November 17, 2000. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K003558 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 17, 2000
Decision Date	April 24, 2001
Days to Decision	158 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.