DEN210033 is an FDA 510(k) submission for the Lenire Tinnitus Treatment Device. This device is classified as a Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus (Class II - Special Controls, product code QVN).
Submitted by Neuromod Devices Limited (Dublin 8, IE). The FDA issued a Not Cleared (DENG) decision on March 6, 2023.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3410. 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) Number | DEN210033 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | August 18, 2021 |
| Decision Date | March 06, 2023 |
| Days to Decision | 565 days |
| Submission Type | Direct |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | - |
| Product Code | QVN - Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3410 |
| 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. |