# DEN210033: Lenire Tinnitus Treatment Device

- Pathway: De Novo (Direct)
- Applicant: Neuromod Devices Limited
- Decided: Mar 6, 2023 after 565 days
- Product code: QVN (Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus)
- Device class: 2
- Regulation: 21 CFR 874.3410
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
Lenire is intended to provide bimodal (sound and transmucosal electrical tongue) stimulation to temporarily relieve the symptoms of tinnitus in patients 18 years of age and older suffering from at least moderate (as defined by the Tinnitus Handicap Inventory) tinnitus. The treatment is intended to be self-administered by the patient following prescription by a healthcare professional who is experienced in the evaluation and management of tinnitus.

Source page: https://510kreport.com/device/DEN210033
Methodology: https://510kreport.com/methodology