Innovative Neurological Devices has secured approval from the US Food and Drug Administration (FDA) for its Cervella cranial electrotherapy stimulator (CES) to treat anxiety, depression and insomnia.
The Cervella CES has been developed to deliver micro pulses of electrical current across patient’s brain.
Cranial electrotherapy stimulators transmit small pulses of electric current across patient’s brain through a pair of conductive electrodes placed on patient’s forehead, mastoid or ear lobes.
As per clinical studies, the electrical stimulation helps to reduce anxiety levels, insomnia, and patient’s depressive mood.
Cervella is claimed to be the world’s first CES with advanced conductive treatment electrodes that were seamlessly incorporated into noise-cancelling Bluetooth-enabled headphones.
The device features an internal rechargeable battery that provides a low-level and constant current to the patient’s cranium through a pair of conductive electrodes integrated into ear pads of over-ear noise-canceling stereo headphones.
Audio and noise cancelling features of the headphones can be used by the patients during treatment, allowing to efficiently use the device during study, work and play.
Cervella is also said to be first CES device that can be managed through an app on a smart device, enabling automated treatment data recording, reminders and analytics to improve patient treatment outcomes.
The app enables the patient to automatically store the treatment history for review by the patient’s healthcare provider.
The company said it launches the Cervella device at the Anxiety and Depression Conference in Chicago, which takes place on 28 March. Cervella is available at the introductory price of $695.
In addition, the firm noted that prescription from a licensed healthcare practitioner is needed to purchase Cervella.
Innovative Neurological Devices president and CEO Bart Waclawik said: “Anxiety, insomnia, and depression are disorders affecting at least 20% of adult population. Furthermore, recent research brought to light that 70% of teenagers list anxiety and depression as the main problem affecting the younger population.
“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.”