Cleared Traditional

SERIES S515/S525 BEHIND-THE-EAR HEARING AID

K880465 · Maico Hearing Instruments, Inc. · Ear, Nose, Throat

Feb 1988

Decision

20d

Days

Class 1

Risk

About This 510(k) Submission

K880465 is an FDA 510(k) clearance for the SERIES S515/S525 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 February 23, 1988, 20 days after receiving the submission on February 3, 1988. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K880465 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 03, 1988
Decision Date	February 23, 1988
Days to Decision	20 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.