510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN210033Unknown

Lenire Tinnitus Treatment Device

Neuromod Devices Limited, Dublin 8, IE / Direct, Unknown
FDA source (opens on fda.gov)

DEN210033 is the FDA 510(k) clearance record for Lenire Tinnitus Treatment Device, a class II device, cleared for Neuromod Devices Limited on under FDA product code QVN (Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus). FDA's definition for product code QVN reads: "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". FDA records list one 510(k) clearance for Neuromod Devices Limited. As of , FDA records show no recalls naming DEN210033.

Clearance record

Decision date
Received
(565 days to decision)
Product code
QVN Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus
Regulation
21 CFR 874.3410
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Neuromod Devices Limited Rainsford St., Dublin 8, IE
Third party review
No

Clearances, product code QVN

Trailing 12 months

FDA records hold no clearances under product code QVN in the trailing twelve months.

FDA records show no clearances under product code QVN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QVN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260