FDA Approves First At-Home Brain Stimulation Device for Treatment of Depression

The US Food and Drug Administration (FDA) has approved an at-home brain stimulation device intended to treat major depressive disorder in adults.¹ This device, FL-100 from Flow Neuroscience, is the first of its kind to be approved in the US.

The FDA’s approval of this brain-stimulation device was based on the Empower phase 2 study showing 58% of patients achieved remission of their depression after 10 weeks. Flow Neuroscience shared that among global users of the device, 77% reported improvement in their symptoms within 3 weeks. The company also noted that over 55,000 patients have used the device across Europe, the UK, Switzerland, and Hong Kong.

The Empower study was a fully remote, multi-center, double-blind, randomized 20-week trial including 174 subjects.² Patients included were 18 years or older, had a diagnosis of unipolar major depressive disorder according to the DSM-5, had a Hamilton Depression Rating Score (HDRS) of 16 or higher, and were allowed antidepressant or psychotherapy regimens as long as they were stable for 6 weeks prior to study enrollment.² Patients were excluded from the study if they were in a current state of mania, diagnosed with other issues that may present as mood disorders, were receiving other interventional therapies for depression, or considered to have treatment resistant depression. Other exclusion criteria included a history of electroconvulsive therapy or transcranial magnetic stimulation, previous hospitalizations for suicidal behavior, severe chronic insomnia, history of epilepsy or seizures, or neurological conditions that may affect safety or study participation.

The primary endpoint of the Empower study was change in HDRS from baseline to week 10, with secondary endpoints including arm difference in HDRS (response rate and remission rate) and arm difference in Montgomery-Asberg Depression Rating Scale (average score change, response rate, and remission rate).

The device is worn as a headset and delivers transcranial direct current stimulation to the dorsolateral prefrontal cortex, a brain region associated with mood. Typical treatment is a 12-week course, with 5 sessions per week for the first 3 weeks, tapering to 2 to 3 sessions weekly for the last 9 weeks. Individual treatment sessions with the brain-stimulation device are 30 minutes. The cranial electrotherapy stimulator is intended for use in the home environment guided by instructions from a digital app, or for use under supervision of a clinician. Adverse effects from use of the device are generally mild and temporary, most commonly including skin irritation, headache, and tingling sensation at electrode sites. Skin burns have also occurred with reused or dried out pads on the device.

Flow’s at-home brain stimulation device is cleared by the FDA to treat moderate to severe major depressive disorders in adults (18 or older) who are not considered resistant to medication.² It can be used as a standalone treatment or in combination with other types of treatments. The company noted that the device may offer an alternative to typical antidepressant treatments.

Flow Neuroscience plans to launch the device in the 2^nd quarter of 2026, available as a prescription-only treatment. The US retail price is estimated to be between $500 and $800, with insurance coverage details being announced in early 2026.¹

References

1. Choudry K. US FDA approves first at-home device for depression. December 11, 2025. Accessed December 12, 2025. https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-first-at-home-device-depression-2025-12-11/

2. Summary of safety and effectiveness data. US Food and Drug Administration. Accessed December 12, 2025. https://www.accessdata.fda.gov/cdrh_docs/pdf23/P230024B.pdf