Not Cleared Post-NSE

DEN100025 - WIDEXLINK IN CLEAR SERIES HEARING AIDS (FDA 510(k) Clearance)

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

DEN100025 · Office Research IN Clinical Amplifiction · Ear, Nose, Throat device
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Mar 2011
Decision
169d
Days
Class 2
Risk

DEN100025 is an FDA 510(k) submission (not cleared) for the WIDEXLINK IN CLEAR SERIES HEARING AIDS. Classified as Hearing Aid, Air-conduction With Wireless Technology, Prescription (product code OSM), Class II - Special Controls.

Submitted by Office Research IN Clinical Amplifiction (Lisle, US). The FDA issued a Not Cleared (DENG) decision on March 31, 2011 after a review of 169 days.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3305 - 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 Office Research IN Clinical Amplifiction devices

Submission Details

510(k) Number DEN100025 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received October 13, 2010
Decision Date March 31, 2011
Days to Decision 169 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
80d slower than avg
Panel avg: 89d · This submission: 169d
Pathway characteristics

Device Classification

Product Code OSM Hearing Aid, Air-conduction With Wireless Technology, Prescription
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3305
Definition A Wireless Air-conduction Hearing Aid Is A Wearable Sound-amplifying Device, Intended To Compensate For Impaired Hearing That Incorporates Wireless Technology In Its Programming Or Use. This Is A Prescprition Hearing Aid.
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.