Cleared Traditional

K953728 - RX12 LINEAR FULL SHELL AND IN THE CANAL

K953728 is an FDA 510(k) clearance for RX12 LINEAR FULL SHELL AND IN THE CANAL, manufactured by Midwest City Hearing Aid Center. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K953728 · Midwest City Hearing Aid Center · Ear, Nose, Throat device
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Sep 1995
Decision
33d
Days
Class 1
Risk

K953728 is an FDA 510(k) clearance for the RX12 LINEAR FULL SHELL AND IN THE CANAL. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Midwest City Hearing Aid Center (Midwest City, US). The FDA issued a Cleared decision on September 12, 1995 after a review of 33 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 Midwest City Hearing Aid Center devices

FDA 510(k) Submission Details - K953728

510(k) Number K953728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1995
Decision Date September 12, 1995
Days to Decision 33 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 89d · This submission: 33d
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 740
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K953728.
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