Cleared Traditional

SERIES STAR 22 - BEHIND THE EAR HEARING AID

K931161 · Maico Hearing Instruments, Inc. · Ear, Nose, Throat

Jun 1993

Decision

85d

Days

Class 1

Risk

About This 510(k) Submission

K931161 is an FDA 510(k) clearance for the SERIES STAR 22 - BEHIND THE EAR HEARING AID, 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 June 1, 1993, 85 days after receiving the submission on March 8, 1993. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K931161 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 08, 1993
Decision Date	June 01, 1993
Days to Decision	85 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.