The treatment provided by Flow Neuroscience is CE certified. This means that Flow is approved for medical use and compliant with the strict European laws for medical devices.
The CE certification ensures that:
- Flow is based on scientific evidence
- The treatment reduces depressive symptoms
- The headset is safe to use
The results from several meta-analyses* have shown that the technique used in the Flow headset is safe and has never been associated with brain damage. One such study, conducted in 2016, included 1000 research participants and over 33,200 stimulation sessions. Read more about the science.
*A meta-analysis is a research method that combines results from multiple studies. This means that the results from a meta-analysis are particularly reliable.
The Flow headset gives less severe and fewer side effects than medication, but offers similar results.
Common side effects:
- Skin redness underneath, or near, the electrodes is common due to increased local blood flow. This is harmless and will subside 30-60 minutes after use.
- Some users experience skin irritation underneath the electrodes. In such cases, the headset should not be reapplied to irritated skin.
Rare side effects:
- Users who suffer from tinnitus have reported rare cases of intensified symptoms, such as noise or ringing in the ears.
Should you experience sharp pain during stimulation, or an increase of depressive symptoms, discontinue the treatment immediately and consult a physician.
- Using the Flow device poses minimal risk of injury. Even so, it is recommended to consider multiple treatment options. Always consult a healthcare professional before use.
- The Flow device should only be used by people over 18 years of age who have been diagnosed with depression (Major Depressive Disorder).
- The Flow device should not be applied to open wounds or damaged skin.
- Always consult a physician before making any changes to your current medication.
Take extra precaution and make sure to consult your physician under the following circumstances:
- Pregnancy (or suspected pregnancy)
- Suicidal thoughts (thoughts about ending your life)
- Bipolar disorder (or having a history of hypomanic/manic episodes)
- Epilepsy (or having a history of seizures)
- Heart disease (or suspected heart disease)
- A neurological or neuropsychiatric condition
- Having recently had a surgical procedure
- Having a defect in neurocranium and/or an implant inside the skull
- Having an active, implanted medical device (e.g. cardiac pacemaker, spinal cord stimulator, vagal nerve stimulator, auricular stimulator, deep-brain stimulating electrodes, cochlear implant, implanted hearing aid or defibrillator) or other implanted, metallic or electronic device.