Cleared Traditional

K964669 - MIRACLE-EAR OR AUDIOTONE

K964669 is an FDA 510(k) clearance for MIRACLE-EAR OR AUDIOTONE, manufactured by Miracle-Ear, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K964669 · Miracle-Ear, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
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Dec 1996
Decision
35d
Days
Class 1
Risk

K964669 is an FDA 510(k) clearance for the MIRACLE-EAR OR 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 26, 1996 after a review of 35 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

FDA 510(k) Submission Details - K964669

510(k) Number K964669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1996
Decision Date December 26, 1996
Days to Decision 35 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
55d faster than avg
Panel avg: 90d · This submission: 35d
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 953
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K964669.
SENSO DIGITAL (C18)
K965218 · Widex Hearing Aid Co., Inc. · Jan 1997
TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-II
K964639 · Telex Communications, Inc. · Jan 1997
AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EAR
K964816 · Audina Hearing Instrument · Jan 1997
DAHLBERG K-AMP BTE
K964794 · Miracle-Ear, Inc. · Dec 1996
DIGIFOCUS ITE
K964683 · Oticon, Inc. · Dec 1996
AHS OMEGA CONCEPT
K963877 · Authorized Hearing Systems, Inc. · Dec 1996