FDA Clears Cervella Cranial Electrotherapy Stimulator for Insomnia


The device, also cleared to treat anxiety and depression, was launched at the Anxiety and Depression Conference in Chicago and will be available in the United States starting at $695.

Dr Bruce Bebo

Bruce Bebo, PhD, Executive Vice President Research, National MS Society

Innovative Neurological Devices has received market clearance from the FDA for its Cervella Cranial Electrotherapy medical device to treat insomnia, anxiety, and depression by delivering micro-pulses of electric current through the brain.

This is the first cranial electrotherapy stimulator (CES) with proprietary conductive treatment electrodes integrated into ear pads of over-ear noise-canceling Bluetooth-enabled headphones, which can be used during treatment. The device features an internal rechargeable battery that provides a low-level and consistent current to the cranium. Cervella is the first CES managed through an app via a smart device. It allows for automatic storage of treatment history, reminders, and analytics and gives patients the option to share treatment data with healthcare providers to better manage the treatment plan and improve patient outcomes.

“Anxiety, insomnia, and depression are disorders affecting at least 20% of adult population,” Bart Waclawik, president, and CEO, Innovative Neurological Devices, said in a statement.1 “For many years, CES devices have been clinically validated as a safe and effective alternative to drug-based therapies without the side-effects that often exist with the use of antidepressants.”

The device was launched at the Anxiety and Depression Conference in Chicago March 28, and will be available in the United States starting at $695. A prescription from a licensed healthcare practitioner is required to purchase the device.

“We hope that by incorporating treatment electrodes into a noise-cancelling headset, patient compliance will significantly increase and, consequently, treatment outcomes will improve,” Waclawik added. “Also, by making the Cervella device appear indistinguishable from ordinary over-ear headphones, patients will have the freedom to use the device in anxiety-inducing situations without curious looks from onlookers. Last but not least, the automated data aggregation available through the proprietary Cervella app gives a patient an option to easily share treatment data with his or her health provider in order to better manage the treatment plan.”


FDA Clears the Cervella Cranial Electrotherapy Stimulator for Treatment of Anxiety, Insomnia, and Depression [news release]. Carmel, Ind.: Innovative Neurological Devices; March 27, 2019. prnewswire.com/news-releases/fda-clears-the-cervella-cranial-electrotherapy-stimulator-for-treatment-of-anxiety-insomnia-and-depression-300818879.html

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