French medtech startup Naox Technologies this month became the first company to receive FDA 510(k) clearance for an in-ear electroencephalogram (EEG) device — a move that could shift brain monitoring away from bulky, scalp-based EEG systems to a compact ear-worn platform.
Unlike traditional EEG systems that use upwards of 20 scalp electrodes, Naox’s device aims to be comfortable and is easy for patients to apply by themselves. The device captures electrical brain activity through a small sensor embedded in an earplug, which helps enable ongoing real-world monitoring — something conventional EEGs can’t easily do, as they are limited to short clinical sessions.
Naox’s device, called Naox Link, can be worn for extended periods in everyday settings, even while exercising and sleeping. This improves the chance of capturing important neurological events that might otherwise go unseen, explained Naox CEO Hugo Dinh.
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That ease of use opens the door to a kind of continuous brain monitoring that has so far been largely absent as an option, he noted.
“For heart health, you have for example, watches that track heart rate or ECG, but today, there’s nothing for brain and mind wearables,” Dinh declared.
Naox’s device seeks to improve care in neurology, epilepsy and sleep medicine by capturing brain activity outside of brief, clinic-based sessions. Dinh said that monitoring brain activity during everyday life could give clinicians a clearer picture of neurological conditions that appear sporadically or depend on real-world triggers. Instances like seizures, fainting episodes or other certain cognitive symptoms may only occur occasionally, during sleep, under stress, during exercise or at home — not during a 30-minute test in a hospital.
By extending EEG monitoring beyond the clinic, Naox also hopes to reduce the amount of missed or delayed diagnoses that come as a result of one-time tests, Dinh added.
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Naox’s system is already being used in select neurology and sleep centers, with broader availability across the U.S. planned for later this year.
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