Cleared Traditional

SUPER-SIL

K940164 · Finetone Hearing Instruments · Ear, Nose, Throat

Jun 1994

Decision

174d

Days

Class 1

Risk

About This 510(k) Submission

K940164 is an FDA 510(k) clearance for the SUPER-SIL, a Hearing Aid, Air-conduction, Prescription (Class I — General Controls, product code ESD), submitted by Finetone Hearing Instruments (South Portland, US). The FDA issued a Cleared decision on June 29, 1994, 174 days after receiving the submission on January 6, 1994. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K940164 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 06, 1994
Decision Date	June 29, 1994
Days to Decision	174 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.