QVN · Class II · 21 CFR 874.3410

FDA Product Code QVN: Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus

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.

Leading manufacturers include Neuromod Devices Limited.

1
Total
0
Cleared
565d
Avg days
2023
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus Devices (Product Code QVN)

1 devices
1–1 of 1
Not Cleared Mar 06, 2023
Lenire Tinnitus Treatment Device
DEN210033
Neuromod Devices Limited
Ear, Nose, Throat · 565d

About Product Code QVN - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code QVN since 2023, with 0 receiving FDA clearance (average review time: 565 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

QVN devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →