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# Evren ‘Breakthrough’ on Earbud PTSD Therapy
- URL: https://www.fdaweb.com/evren-breakthrough-on-earbud-ptsd-therapy/
- Published: 2021-07-26T12:00:00.000Z
- Updated: 2026-09-14T17:07:47.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5149785

FDA has granted Evren Technologies a breakthrough device designation for its Phoenix earbud device and its use in treating post-traumatic stress disorder. The device is intended to provide transcutaneous auricular vagal nerve stimulation in a proprietary closed-loop system. To obtain the designaion, the company says it provided preliminary clinical evidence demonstrating substantial improvement on a clinically significant endpoint compared with other available therapies.