Cleared Traditional

K897035 - MIRACLE EAR MODEL PC PROG. IN-THE-EAR H...

K897035 is the FDA 510(k) clearance for MIRACLE EAR MODEL PC PROG. IN-THE-EAR H... 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 156-day FDA review.

K897035 · Miracle-Ear, Inc. · Ear, Nose, Throat device
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May 1990
Decision
156d
Days
Class 1
Risk

K897035 is an FDA 510(k) clearance for the MIRACLE EAR MODEL PC PROG. IN-THE-EAR HEARING AID. 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 May 23, 1990 after a review of 156 days - an extended review 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: 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 K897035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1989
Decision Date May 23, 1990
Days to Decision 156 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 89d · This submission: 156d
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 K897035.
AUDIOTONE ITE HEARING AID MODEL ZG (MIRAGE)
K901747 · Miracle-Ear, Inc. · May 1990
AUDIOTONE ITE HEARING AID MODEL ZA (MICRO)
K901783 · Miracle-Ear, Inc. · May 1990
WIDEX BTE HEARING AID MODEL Q16 WITH REMOTE
K897033 · Widex Hearing Aid Co., Inc. · May 1990
PHONAK ITE 8000, 7000, 6000 ITE HEARING AID
K900675 · Phonak, Inc. · May 1990
BTE SUPER-FRONT PPSCL, SUPER-FRONT PPSC
K900829 · Phonak, Inc. · May 1990
BTE SUPER-FRONT PPCL4, SUPER-FRONT PPC4
K900830 · Phonak, Inc. · May 1990