Cleared Traditional

K942107 - MAGIC EAR

K942107 is an FDA 510(k) clearance for MAGIC EAR, manufactured by Novaplex, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 282-day FDA review.

K942107 · Novaplex, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
282d
Days
Class 1
Risk

K942107 is an FDA 510(k) clearance for the MAGIC EAR, ELAIN. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Novaplex, Inc. (Sun Valley, US). The FDA issued a Cleared decision on February 8, 1995 after a review of 282 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3300 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Novaplex, Inc. devices

FDA 510(k) Submission Details - K942107

510(k) Number K942107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1994
Decision Date February 08, 1995
Days to Decision 282 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
193d slower than avg
Panel avg: 89d · This submission: 282d
Pathway characteristics
Predicate-based equivalence.

ESD Device Classification - Class 1, General Controls

Product Code ESD Hearing Aid, Air-conduction, Prescription
Device Class Class 1 - 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.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - ESD Hearing Aid, Air-conduction, Prescription

All 740
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K942107.
MAICO IN-THE-EAR MODEL RD-312 CIC
K950637 · Maico Hearing Instruments, Inc. · Mar 1995
DYNA 231X
K950758 · Phonak, Inc. · Mar 1995
RESOUND(R) RESOURCE(TM)
K945750 · Resound Corp. · Mar 1995
RESOUND(R) PERSONAL HEARING SYSTEM ED-3 ENCORE
K950319 · Resound Corp. · Feb 1995
LX-ITC
K946071 · Widex Hearing Aid Co., Inc. · Jan 1995
MAICO IN-THE-EAR MODEL RD 201
K946253 · Maico Hearing Instruments, Inc. · Jan 1995