Cleared Traditional

CUSTOM IN-THE-EAR HEARING AID

K830960 · Finetone Hearing Instruments · Ear, Nose, Throat

Jun 1983

Decision

97d

Days

Class 1

Risk

About This 510(k) Submission

K830960 is an FDA 510(k) clearance for the CUSTOM IN-THE-EAR HEARING AID, a Hearing Aid, Air-conduction, Prescription (Class I — General Controls, product code ESD), submitted by Finetone Hearing Instruments (Mchenry, US). The FDA issued a Cleared decision on June 30, 1983, 97 days after receiving the submission on March 25, 1983. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K830960 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 25, 1983
Decision Date	June 30, 1983
Days to Decision	97 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	—

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.