QVN
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3410
- Medical specialty
- Ear, Nose, Throat
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| Lenire Tinnitus Treatment Device (DEN210033) | Neuromod Devices Limited | 2023-03-06 |
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Every clearance here is in the API, with alerts when new ones post.