DeviceClearance

Product code QVN— Ear, Nose, Throat

Lenire Tinnitus Treatment Device

Classification name
Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus
Device class
Class 2
Regulation
21 CFR 874.3410
Advisory panel
Ear, Nose, Throat
Total cleared
1
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code QVN under 21 CFR 874.3410, via openFDA

Market context for product code QVN

FDA has cleared 1 device under product code QVN, all in 2023, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QVN

Recent clearances under product code QVN

Data sourced from openFDA. This site is unofficial and independent of the FDA.