Cleared Traditional

SEARS MODEL JCS IN-THE-EAR HEARING INSTRUMENT (K901470) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K901470 · Miracle-Ear, Inc. · Ear, Nose, Throat device
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Apr 1990
Decision
20d
Days
Class 1
Risk

K901470 is an FDA 510(k) clearance for the SEARS MODEL JCS IN-THE-EAR HEARING INSTRUMENT. 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 April 16, 1990 after a review of 20 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 K901470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1990
Decision Date April 16, 1990
Days to Decision 20 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 89d · This submission: 20d
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 18
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K901470.
3M MODEL 8245 ITE HEARING AID
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MEMORYMATE MODEL 8270 ITE HEARING AID
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MEMORYMATE HEARING AID WITH PMC PROGRAMMER
K904020 · 3M Company · Dec 1990
3M INSTANT FIT CUSTOM EARMOLD
K895134 · 3M Company · Oct 1989
MEMORYMATE HEARING AID MODEL 8200
K880082 · 3M Company · Mar 1988
3M INSTANT FIT CUSTOM EARMOLD
K870985 · 3M Company · Mar 1987