FDA Cleared: French Startup’s In-Ear EEG Device

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NEW YORK, January 21, 2026 – A French tech company this month received Food and Drug Administration (FDA) clearance for a groundbreaking in-ear electroencephalogram (EEG) device, potentially revolutionizing how brain activity is monitored. This marks the first time the FDA has cleared such a device, shifting brain monitoring away from traditional, cumbersome scalp-based systems toward a compact, ear-worn platform.

A New Era of Brain Monitoring

The new device offers a cozy, user-pleasant alternative to traditional EEG systems.

Unlike conventional EEGs that require upwards of 20 electrodes attached to the scalp, Naox Technologies’ device, called naox Link, is designed for comfort and ease of self-application. The device captures electrical brain activity through a small sensor embedded in an earplug, enabling continuous, real-world monitoring-a capability largely absent in traditional clinical settings.

Naox Link can be worn for extended periods during everyday activities, including exercise and sleep. This increases the likelihood of capturing crucial neurological events that might otherwise be missed, according to Hugo Dinh, CEO of Naox.

Did you know?– EEGs measure electrical activity in the brain using electrodes. The FDA clearance for Naox Link represents a important shift toward more accessible and convenient brain monitoring technology.

“For heart health,you have,such as,watches that track heart rate or ECG,but today,there’s nothing for brain and mind wearables,” Dinh declared. This ease of use unlocks a new level of continuous brain monitoring that hasn’t been readily available until now.

Improving Neurological Care

naox’s device aims to enhance care in neurology,epilepsy,and sleep medicine by capturing brain activity outside of brief clinical sessions. Dinh explained that monitoring brain activity during daily life coudl provide clinicians with a more extensive understanding of neurological conditions that manifest sporadically or are triggered by real-world factors.

Seizures, fainting episodes, and certain cognitive symptoms often occur intermittently-during sleep, under stress, while exercising, or at home-and may not be detectable during a standard 30-minute hospital test.By extending EEG monitoring beyond the clinic, Naox hopes to reduce the number of missed or delayed diagnoses resulting from one-time assessments.

Pro tip– Continuous EEG monitoring can definitely help identify patterns in brain activity that might potentially be missed during traditional, short-duration tests.this can lead to more accurate diagnoses.

Naox’s system is currently being utilized in select neurology and sleep centers, with plans for broader availability across the U.S. later this year.

Reader question– How might this technology change the way doctors approach diagnosing and treating neurological conditions? Share your thoughts!

What’s the benefit of continuous EEG monitoring? Continuous monitoring allows clinicians to observe brain activity in natural settings, potentially revealing patterns and events that wouldn’t be apparent during a short, clinic-based test.

Naox Technologies, a French tech company, developed the Naox Link, an in-ear EEG device. The FDA granted 510(k) clearance to the device in January 2026.The device’s purpose is to provide a more comfortable and convenient way to monitor brain activity compared to traditional EEG systems. It works by capturing electrical signals through a sensor in an earplug,allowing for continuous monitoring during daily activities.Naox Link is currently being used in select centers and will be available more broadly in the U.S. later in 2026. The goal is to improve diagnosis and treatment of neurological conditions like epilepsy and sleep disorders by capturing events that might be missed in a clinical setting.