Cleared Traditional

FINETONE FSC,

K955692 · Finetone Hearing Instruments · Ear, Nose, Throat

Feb 1996

Decision

50d

Days

Class 1

Risk

About This 510(k) Submission

K955692 is an FDA 510(k) clearance for the FINETONE FSC,, a Hearing Aid, Air-conduction, Prescription (Class I — General Controls, product code ESD), submitted by Finetone Hearing Instruments (Scarborough, US). The FDA issued a Cleared decision on February 2, 1996, 50 days after receiving the submission on December 14, 1995. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K955692 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 14, 1995
Decision Date	February 02, 1996
Days to Decision	50 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.