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FDA Clears Brain Device for Home Depression Treatment
12 Dec
Summary
- FDA cleared an at-home device for depression treatment.
- The prescription headset uses gentle electrical stimulation.
- Device offers expanded access to mental health care.
An innovative at-home device utilizing gentle electrical stimulation to treat depression has received clearance from the U.S. Food and Drug Administration (FDA). This prescription headset, developed by Flow Neuroscience, targets specific brain areas involved in mood and stress regulation, potentially democratizing access to mental health treatments. Similar therapies are available in clinics, but this device marks a significant step towards making such interventions accessible in patients' homes.
The device employs transcranial direct current stimulation (tDCS), a method that has been explored for years with varying outcomes. A key clinical trial published in Nature Medicine demonstrated its efficacy, showing that adults using the headset for 30-minute sessions over ten weeks experienced greater relief from depression symptoms compared to a placebo group. Approximately 58% of participants using the stimulation achieved remission, with only mild side effects like skin redness reported.
While the FDA acknowledged certain limitations in the research, it determined that the device's modest benefits outweighed potential risks. Flow Neuroscience anticipates the headset will be available in the U.S. by mid-2026 for around $500, with hopes for insurance coverage to begin by the end of next year. The company has already sold over 55,000 devices in Europe since 2019.
