Cleared Traditional

K934940 - MIRACLE-EAR ENTRE

K934940 is the FDA 510(k) clearance for MIRACLE-EAR ENTRE 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 140-day FDA review.

K934940 · Miracle-Ear, Inc. · Ear, Nose, Throat device
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Mar 1994
Decision
140d
Days
Class 1
Risk

K934940 is an FDA 510(k) clearance for the MIRACLE-EAR ENTRE. 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 March 7, 1994 after a review of 140 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 K934940 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1993
Decision Date March 07, 1994
Days to Decision 140 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
51d slower than avg
Panel avg: 89d · This submission: 140d
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 K934940.
RIONET HEARING AID HB-53CI
K936122 · Authorized Hearing Systems, Inc. · Mar 1994
MIRACLE-EAR CONFIDANTE
K940458 · Miracle-Ear, Inc. · Mar 1994
WIDEX R.C. 2 (REMOTE CONTROL)
K935424 · Widex Hearing Aid Co., Inc. · Mar 1994
PHONAK PICONET 232X-AZ BTE HEARING INSTRUMENT
K935791 · Phonak, Inc. · Jan 1994
BINAURAL HEARING AID
K935366 · Telex Communications, Inc. · Jan 1994
PRO FIT-CYBER II OPTION
K935289 · Qualitone · Dec 1993