Naox Technologies has received FDA 501(k) clearance for its wired electroencephelography (EEG) earphones, Naox Link.
Paris-based Naox Technologies says it is taking its EEG sensors to the next level by making them small enough to be earbuds.
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These wired EEG earphones, showcased at CES 2026 in Las Vegas this week, would allow healthcare professionals to monitor brain activity remotely. In addition, the company’s Naox Wave is a consumer-focused set of earbuds that can be integrated with any true wireless stereo (TWS) earbuds.
This functionality allows original equipment manufacturer partners to add real brain-signal sensing to devices people already wear every day.
Naox Technologies says its Naox Link will become the first in-ear EEG device for clinical use in home and healthcare environments. This use enables longer-duration acquisition of brain electrical activity.
More about Naox Link
EEG in the past needed a setup of 20 electrodes with conductive gels, allowing only short recordings confined to clinical settings, according to Naox Technologies.
“Until now, EEG has required bulky equipment and brief recordings captured in clinical settings, often after weeks or even months of wait times,” Hugo Dinh, co-founder and CEO of Naox Technologies, said in a news release. “Naox Link enables clinicians to acquire reliable and interpretable EEG over longer periods in home or healthcare environments, using a device that is simple for patients to set up and use, while maintaining clinical-grade signal quality.”
Under the direction and interpretation of a licensed medical professional, NAOX LINK will acquire, record, and transmit one channel of EEG data. The system uses a wired pair of earbuds with soft electrodes placed on the eartips. Patients place earbuds in their ears, and EEG data is transmitted to the medical professional via a HIPAA-certified cloud.
Brain health is a challenge of the 21st century. More than 2 billion people worldwide suffer from neurological, mental health, or sleep-related disorders, which influence how they think, feel, perform, and age. These challenges add to personal and clinical burden, further adding to substantial societal costs of productivity loss.
With FDA clearance, Naox Link will be used across a range of professional settings, including neurology and epilepsy centers, sleep labs and sleep medicine practices, and academic and pharmaceutical research environments. This implementation will support longer-duration EEG monitoring and research outside traditional hospital workflows.
More about Naox Wave
Naox Wave is a consumer wellness technology informed by Naox’s expertise in in-ear sensing but is not FDA cleared and is not intended for medical use.
Brain-signal data can be captured during activities such as working, relaxing, or sleeping. These signals are processed in the Naox app to generate insights on mental health management, sleep analytics, and cognitive performance. The Naox App presents intuitive visual summaries based on specific EEG biomarkers to estimate vigilance, focus, relaxation, and brain aging.
“As EEG moves into earbuds, it will do for the brain what heart sensors did for wearables a decade ago. By developing in-ear EEG technology designed for consumer use, and a modular platform that can integrate into some of the world’s best-known audio brands, we’re excited to help bring credible brain-signal awareness to millions of people,” said Mathieu Letombe, Naox advisor and. former CEO of Withings.
Naox Link is now available to healthcare professionals, and Naox Wave is expected to begin rolling out toward the end of 2026.
