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French Startup Gains FDA Clearance for First In‑Ear EEG Device

Your Health 247 by Your Health 247
January 21, 2026
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French Startup Gains FDA Clearance for First In‑Ear EEG Device
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French medtech startup Naox Applied sciences this month grew to become the primary firm to obtain FDA 510(ok) clearance for an in-ear electroencephalogram (EEG) machine — a transfer that would shift mind monitoring away from cumbersome, scalp-based EEG techniques to a compact ear-worn platform.

In contrast to conventional EEG techniques that use upwards of 20 scalp electrodes, Naox’s machine goals to be snug and is simple for sufferers to use by themselves. The machine captures electrical mind exercise via a small sensor embedded in an earplug, which helps allow ongoing real-world monitoring — one thing standard EEGs can’t simply do, as they’re restricted to brief medical classes.

Naox’s machine, known as Naox Hyperlink, might be worn for prolonged durations in on a regular basis settings, even whereas exercising and sleeping. This improves the possibility of capturing vital neurological occasions which may in any other case go unseen, defined Naox CEO Hugo Dinh.

That ease of use opens the door to a form of steady mind monitoring that has to date been largely absent as an choice, he famous.

“For coronary heart well being, you could have for instance, watches that observe coronary heart fee or ECG, however immediately, there’s nothing for mind and thoughts wearables,” Dinh declared.

Naox’s machine seeks to enhance care in neurology, epilepsy and sleep medication by capturing mind exercise exterior of temporary, clinic-based classes. Dinh mentioned that monitoring mind exercise throughout on a regular basis life may give clinicians a clearer image of neurological situations that seem sporadically or rely on real-world triggers. Cases like seizures, fainting episodes or different sure cognitive signs might solely happen often, throughout sleep, below stress, throughout train or at house — not throughout a 30-minute check in a hospital.

By extending EEG monitoring past the clinic, Naox additionally hopes to cut back the quantity of missed or delayed diagnoses that come on account of one-time exams, Dinh added.

Naox’s system is already being utilized in choose neurology and sleep facilities, with broader availability throughout the U.S. deliberate for later this 12 months.

Photograph: MirageC, Getty Pictures



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Tags: clearanceDeviceEEGFDAFrenchGainsInEarstartup
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