Cleared Traditional

K964419 - MIRACLE - EAR (ITE/ITC/CIC)

K964419 is the FDA 510(k) clearance for MIRACLE - EAR (ITE/ITC/CIC) 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 126-day FDA review.

K964419 · Miracle-Ear, Inc. · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Feb 1997
Decision
126d
Days
Class 1
Risk

K964419 is an FDA 510(k) clearance for the MIRACLE - EAR (ITE/ITC/CIC). 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 February 4, 1997 after a review of 126 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 K964419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1996
Decision Date February 04, 1997
Days to Decision 126 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
37d slower than avg
Panel avg: 89d · This submission: 126d
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 K964419.
WIDEX MODEL SENSO DIGITAL (C9)
K965254 · Widex Hearing Aid Co., Inc. · Mar 1997
AHS OMEGA SP
K970057 · Authorized Hearing Systems, Inc. · Feb 1997
PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITS
K964245 · Starkey Laboratories, Inc. · Feb 1997
DAHLBERG (A-554)
K965049 · Miracle-Ear, Inc. · Jan 1997
AUDIOTONE (A554H)
K965057 · Miracle-Ear, Inc. · Jan 1997
AUDIOTONE (A-552)
K965063 · Miracle-Ear, Inc. · Jan 1997