Cleared Traditional

K153634 - Wireless Earlens Light Driven Hearing Aid

K153634 is an FDA 510(k) clearance for Wireless Earlens Light Driven Hearing Aid, manufactured by Earlens Corporation. The device is a Class 2 Ear, Nose, Throat device with product code PLK cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K153634 · Earlens Corporation · Ear, Nose, Throat device
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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.

View all Earlens Corporation devices

FDA 510(k) Submission Details - K153634

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 90d · This submission: 110d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PLK Device Classification - Class 2, Special Controls

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.