Cleared Traditional

K954941 - MIRACLE EAR AND AUDIOTONE

K954941 is the FDA 510(k) clearance for MIRACLE EAR AND AUDIOTONE 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 53-day FDA review.

K954941 · Miracle-Ear, Inc. · Ear, Nose, Throat device
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Dec 1995
Decision
53d
Days
Class 1
Risk

K954941 is an FDA 510(k) clearance for the MIRACLE EAR AND AUDIOTONE. 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 December 22, 1995 after a review of 53 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Miracle-Ear, Inc. devices

Submission Details

510(k) Number K954941 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1995
Decision Date December 22, 1995
Days to Decision 53 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
36d faster than avg
Panel avg: 89d · This submission: 53d
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 K954941.
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 MIRAGE
K954119 · Miracle-Ear, Inc. · Jan 1996
RESOUND PERSONAL HEARING SYSTEM BTP W/DAI
K955574 · Resound Corp. · Dec 1995
CYBER III OPTION UM, UC312, UC10, UCIC
K955359 · Qualitone · Dec 1995
TELEX 349 MULTI CROS W/ADAPIVE COMPRESSION
K954579 · Telex Communications, Inc. · Dec 1995