Cleared Traditional

K153634 - Wireless Earlens Light Driven Hearing Aid (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K153634 · Earlens Corporation · Ear, Nose, Throat device
Apr 2016
Decision
110d
Days
Class 2
Risk

K153634 is an FDA 510(k) clearance for the Wireless Earlens Light Driven Hearing Aid. 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 Cleared decision on April 6, 2016 after a review of 110 days - within the typical 510(k) review window.

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 establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

Submission Details

510(k) Number K153634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2015
Decision Date April 06, 2016
Days to Decision 110 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 158d · This submission: 110d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.