Not Cleared Direct

DEN150002 - EarLens Contact Hearing Device (FDA 510(k) Clearance)

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

DEN150002 · Earlens Corporation · Ear, Nose, Throat device
Sep 2015
Decision
270d
Days
Class 2
Risk

DEN150002 is an FDA 510(k) submission (not cleared) for the EarLens Contact Hearing Device. Classified as Tympanic Membrane Direct Contact Hearing Aid (product code PLK), Class II - Special Controls.

Submitted by Earlens Corporation (Menlo Park, US). The FDA issued a Not Cleared (DENG) decision on September 29, 2015 after a review of 270 days.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3315 - 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: Regulatory edge-case submission. Elevated predicate reliance profile. With 270 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

Submission Details

510(k) Number DEN150002 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received January 02, 2015
Decision Date September 29, 2015
Days to Decision 270 days
Submission Type Direct
Review Panel Ear, Nose, Throat (EN)
Summary -
Regulatory Context
Review time vs. panel average
112d slower than avg
Panel avg: 158d · This submission: 270d
Pathway characteristics

Device Classification

Product Code PLK Tympanic Membrane Direct Contact Hearing Aid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3315
Definition A Tympanic Membrane Contact Hearing Aid Is Intended To Compensate For Impaired Hearing By Transmitting Amplified Sound By Vibrating The Tympanic Membrane Through A Transducer That Is In Direct Contact With The Tympanic Membrane.
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.