FDA Clears In-Ear EEG System for Remote Monitoring
USA: The FDA has cleared a novel in-ear electroencephalography (EEG) system developed by Naox Technologies, enabling EEG monitoring outside hospital settings. The Naox Link platform is the first in-ear EEG device approved for prescription use at home or in healthcare facilities. It uses wired earbuds with electrode tips to capture, record, and transmit single-channel EEG data, supporting more accessible and continuous brain monitoring.
Naox Technologies has received U.S. Food and Drug Administration 510(k) clearance for NAOX LINK (NX01), representing a major advance in EEG technology. For decades, EEG testing has relied on cumbersome headgear, multiple scalp electrodes, and conductive gels, restricting recordings to short sessions in clinical environments. NAOX LINK addresses these limitations by integrating EEG electrodes into a soft, biocompatible in-ear design that allows more natural and extended monitoring.
The system is cleared to non-invasively acquire, record, and transmit single-channel EEG data and is approved for use in both adults and children aged six years and older. While the device does not provide automated diagnostic interpretations, it enables clinicians to obtain longer-duration EEG recordings in real-world settings, including patients’ homes. This approach may help capture brain activity that is difficult to detect during brief, in-clinic EEG sessions.
By moving EEG acquisition from the scalp to the ear canal, NAOX LINK offers a discreet and comfortable alternative that supports monitoring during daily activities and sleep. According to the company, this capability is particularly valuable for identifying intermittent or infrequent neurological events and for observing long-term brain activity patterns that reflect patients’ everyday lives rather than artificial clinical conditions.
The technology behind NAOX LINK is the result of more than eight years of research focused on miniaturized hardware, advanced signal processing, and clinical validation. Published studies have demonstrated strong agreement between in-ear EEG signals and traditional low-temporal scalp EEG recordings, especially in the assessment of sleep stages and neurological activity.
NAOX LINK is designed to support a wide range of clinical and research applications. In neurology and epilepsy care, it may complement short hospital-based EEG studies by enabling long-term ambulatory monitoring and improving the likelihood of capturing rare events. In sleep medicine, overnight EEG recordings conducted at home could allow more natural evaluation of sleep architecture. The system also has potential value in clinical research, including pediatric studies and investigations into neurodegenerative conditions.
Naox Technologies is already collaborating with several European hospitals and research institutions on studies involving pediatric epilepsy, focal epilepsies in adults, and epileptiform activity in individuals at risk of Alzheimer’s disease. Following FDA clearance, the company plans to expand its clinical partnerships in the United States.
NAOX LINK is currently available to selected U.S. neurology and sleep centers, with broader availability expected in 2026. Founded in Paris in 2018, Naox Technologies focuses on developing medical-grade brain monitoring systems that enable high-quality, long-duration EEG recording in both clinical and home settings.
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