French medtech startup Naox Technologies this month became the first company to receive FDA 510(k) clearance for an in-ear electroencephalography (EEG) device, a move that could move brain monitoring from bulky scalp-based EEG systems to compact, ear-worn platforms.
Unlike traditional EEG systems that use more than 20 scalp electrodes, Naox's device is designed to be comfortable and easy for patients to use on their own. The device captures brain electrical activity through small sensors embedded in the earbuds, which helps enable continuous real-world monitoring — something traditional EEGs cannot easily do because they are limited to short-term clinical sessions.
Naox's device, called Naox Link, can be worn for extended periods of time in everyday settings, even while exercising and sleeping. This improves the chances of capturing important neural events that might otherwise go unnoticed, explains Naox CEO Hugo Dinh.
He points out that this ease of use opens the door to a kind of continuous brain monitoring that until now has largely not been an option.
“For heart health, you can use watches that track heart rate or EKG, but today, there aren’t any wearable devices for the brain and mind,” Dinh declared.
Naox's device is designed to improve care in neurology, epilepsy and sleep medicine by capturing brain activity outside of brief clinical treatments. Monitoring brain activity in daily life could give clinicians a clearer picture of neurological conditions that arise sporadically or depend on real-world triggers, Ding said. Situations such as seizures, fainting, or certain other cognitive symptoms may occur only during sleep, under stress, during exercise, or occasionally at home, rather than during a 30-minute test in the hospital.
By extending EEG monitoring beyond the clinic, Naox also hopes to reduce the number of missed or delayed diagnoses due to one-time testing, Dinh added.
Naox's system is already in use at select neurology and sleep centers, with plans to roll it out nationwide later this year.
Photo: MirageC, Getty Images
