Cleared Traditional

MODEL P4/P4X BEHIND-THE-EAR HEARING AID W/PHOX

K882691 · Maico Hearing Instruments, Inc. · Ear, Nose, Throat

Aug 1988

Decision

63d

Days

Class 1

Risk

About This 510(k) Submission

K882691 is an FDA 510(k) clearance for the MODEL P4/P4X BEHIND-THE-EAR HEARING AID W/PHOX, 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 August 30, 1988, 63 days after receiving the submission on June 28, 1988. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K882691 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 28, 1988
Decision Date	August 30, 1988
Days to Decision	63 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.