FDA Approves First At-Home Treatment Device for Depression

The FDA has approved the Flow FL-100 cranial electrotherapy stimulator device as its first at-home transcranial direct current stimulation (tDCS) medical device treatment for depression.¹

The device is approved to treat moderate to severe depression disorders in adults and may be used as a standalone treatment or adjunct to medication in people considered not resistant to medication.

Depression affects about 16 million American adults, according to a 2013 study from the US Department of Health and Human Services.² Another study showed that depression has increased among both adults and adolescents to about 13.1%, and that 87.9% of this population said their depression symptoms negatively impacted their home, work, or social life.³

Flow Neuroscience said their device responds to a "more nuanced picture" of the causes of depression. "Depression physically changes how the brain works, which is why treatment needs to address brain function directly," their website states. The Flow Neuroscience Depression Treatment Headset addresses these functions.⁴

The device has been approved in Sweden since 2019 and has since been approved by the European Medical Association and in Norway, Switzerland, and Hong Kong. In Europe, it retails for 495 euros.

What Do the Data Say?

The FDA's approval is based on the Empower study (NCT05202119), a fully remote, 2-center, double-blind, placebo-controlled, randomized study in the US and UK. A total of 174 patients with major depressive disorder were randomized into active and sham study arms.

Over a 10-week trial, participants had 5 treatment sessions per week for the first 3 weeks and then 3 sessions per week for 7 weeks. Each session lasted 30 minutes.

The primary outcome measured depression symptoms according to the Hamilton Depression Rating Scale. Those in the active arm showed a 9.41 ± 6.25 point improvement; those in the sham arm showed a 7.14 ± 6.10 point improvement (95% confidence interval = 0.51–4.01, P = 0.012).⁵

What Does This Mean for Pharmacists?

Pharmacists will have a significant role to play as this prescription device is rolled out to the public. In Europe, Flow uses pharmacy partnerships as part of their retail strategy; they may possibly use a similar approach in the US to reach potential customers and build interest in their product. Pharmacists are ideally placed to provide usage instructions and guidance to patients on how to use this device and how best to achieve results.

In Europe, Flow is approved as an OTC device. The FDA's approval of the device makes it available only with a prescription, which means pharmacists will serve as access points for patients. While adverse reactions to the headset were mostly mild and dermatologic in nature (redness, irritation, itching, stinging, minor burns), pharmacists will be able to warn users about these possibilities and recommend treatment should they occur.^1,6

REFERENCES

1. Premarket Approval (PMA). Fda.gov. Published 2023. Accessed December 11, 2025. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230024

2. Substance Abuse and Mental Health Services Administration. Results from the 2013 National Survey on Drug Use and Health: Mental Health Findings [PDF – 2.37MB]. U.S. Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, Center for Behavioral Health Statistics and Quality, 2014. Accessed December 11, 2025.

3. Brody D, Hughes J. Prevalence of depression in adolescents and adults: United states, august 2021–august 2023. National Center for Health Statistics. 2025;527(527). doi:https://doi.org/10.15620/cdc/174579. Accessed December 11, 2025.

4. How it works - Flow Neuroscience. Flowneuroscience.com. Published 2024. https://www.flowneuroscience.com/how-it-works/. Accessed December 11, 2024.

5. Woodham RD, Selvaraj S, Lajmi N, et al. Home-based transcranial direct current stimulation treatment for major depressive disorder: a fully remote phase 2 randomized sham-controlled trial. Nature Medicine. Published online October 21, 2024. doi:https://doi.org/10.1038/s41591-024-03305-y. Accessed December 11, 2025.

6. Flow Neuroscience Safety Guide | CE-Certified tDCS Device Information - Flow Neuroscience. Flowneuroscience.com. Published 2024. https://www.flowneuroscience.com/safety-precautions/