Not Cleared Direct

DEN210033 - Lenire Tinnitus Treatment Device (FDA 510(k) Clearance)

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

DEN210033 · Neuromod Devices Limited · Ear, Nose, Throat device
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Mar 2023
Decision
565d
Days
Class 2
Risk

DEN210033 is an FDA 510(k) submission (not cleared) for the Lenire Tinnitus Treatment Device. Classified as Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus (product code QVN), Class II - Special Controls.

Submitted by Neuromod Devices Limited (Dublin 8, IE). The FDA issued a Not Cleared (DENG) decision on March 6, 2023 after a review of 565 days.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3410 - 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. High predicate equivalence gap. With 565 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.

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Submission Details

510(k) Number DEN210033 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received August 18, 2021
Decision Date March 06, 2023
Days to Decision 565 days
Submission Type Direct
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
476d slower than avg
Panel avg: 89d · This submission: 565d
Pathway characteristics

Device Classification

Product Code QVN Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3410
Definition A Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus Is A Device That Provides Acoustic Stimulation In The Ear And External, Electrical Stimulation Of Sensory Nerves To Relieve Tinnitus.
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.