Cleared Traditional

AUDIOFLEX 120

K960031 · Maico Hearing Instruments, Inc. · Ear, Nose, Throat

Mar 1996

Decision

65d

Days

Class 1

Risk

About This 510(k) Submission

K960031 is an FDA 510(k) clearance for the AUDIOFLEX 120, a Hearing Aid, Air-conduction, Prescription (Class I — General Controls, product code ESD), submitted by Maico Hearing Instruments, Inc. (Minneapolis, US). The FDA issued a Cleared decision on March 7, 1996, 65 days after receiving the submission on January 2, 1996. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K960031 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 02, 1996
Decision Date	March 07, 1996
Days to Decision	65 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.