Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus
The Combined Acoustic and Electrical External Stimulation Device for the Relief of Tinnitus is a device that delivers both acoustic stimulation in the ear and external electrical stimulation of sensory nerves simultaneously to provide relief from tinnitus, leveraging multimodal neuromodulation to address the central and peripheral components of tinnitus perception. Classified as FDA Class 2 under regulation 874.3410, it requires 510(k) clearance in the Ear, Nose, and Throat specialty. It is not an implant and not life-sustaining.
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Basic Information
- Product Code
- QVN
- Device Class
- FDA class 2
- Regulation Number
- 874.3410
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN210033 | Lenire Tinnitus Treatment Device | Mar 06, 2023 | Unknown | Neuromod Devices Limited |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.