Not Cleared Post-NSE

DEN020003 - RETROX (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through the Post-NSE 510(k) pathway - typically does not require clinical trials.

DEN020003 · Auric Hearing Systems, Inc. · Ear, Nose, Throat device
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Aug 2002
Decision
60d
Days
Class 2
Risk

DEN020003 is an FDA 510(k) submission (not cleared) for the RETROX. Classified as Hearing Aid, Air Conduction, Transcutaneous System (product code NIX), Class II - Special Controls.

Submitted by Auric Hearing Systems, Inc. (Nahant, US). The FDA issued a Not Cleared (DENG) decision on August 20, 2002 after a review of 60 days.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3950 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Ear, Nose, Throat review framework.

View all Auric Hearing Systems, Inc. devices

Submission Details

510(k) Number DEN020003 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received June 21, 2002
Decision Date August 20, 2002
Days to Decision 60 days
Submission Type Post-NSE
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 89d · This submission: 60d
Pathway characteristics

Device Classification

Product Code NIX Hearing Aid, Air Conduction, Transcutaneous System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3950
Definition The Transcutaneous Air Conduction Hearing Aid System Is A Wearable Sound-amplifying Device That Is Intended To Compensate For Impaired Hearing. It Consists Of An Air Conduction Hearing Aid Attached To A Surgically Fitted Tube System. The Tube Creates An Air Channel Through The Soft Tissue Between Outer Ear Canal And The Post-auricular Region Of The Pinna (ear). The Air Conduction Hearing Aid Attaches To The Post-auricular Opening Of The Tube, Thereby Transmiting Amplified Sound To The Ear Canal Without Occluding The Canal.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.