Cleared Traditional

K954119 - MIRACLE EAR MIRAGE

K954119 is the FDA 510(k) clearance for MIRACLE EAR MIRAGE by Miracle-Ear, Inc.. It is a Class 1 Ear, Nose, Throat device (product code ESD) cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K954119 · Miracle-Ear, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
145d
Days
Class 1
Risk

K954119 is an FDA 510(k) clearance for the MIRACLE EAR MIRAGE. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Miracle-Ear, Inc. (Golden Valley, US). The FDA issued a Cleared decision on January 24, 1996 after a review of 145 days - within the typical 510(k) review window.

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 Miracle-Ear, Inc. devices

Submission Details

510(k) Number K954119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1995
Decision Date January 24, 1996
Days to Decision 145 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 89d · This submission: 145d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 739
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K954119.
DYNAMEQ-II OPTION
K955466 · Qualitone · Feb 1996
WIDEX MODEL SENSO DIGITAL (C8)
K955878 · Widex Hearing Aid Co., Inc. · Feb 1996
RESOUND PERSONAL HEARING SYSTEM BT247
K955867 · Resound Corp. · Feb 1996
MIRACLE EAR AND AUDIOTONE
K954941 · Miracle-Ear, Inc. · Dec 1995
RESOUND PERSONAL HEARING SYSTEM BTP W/DAI
K955574 · Resound Corp. · Dec 1995
CYBER III OPTION UM, UC312, UC10, UCIC
K955359 · Qualitone · Dec 1995