Naox Technologies has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the NAOX LINK (NX01). The regulatory milestone marks a major advancement in the way electroencephalography (EEG) can be delivered and accessed in clinical practice.

For decades, EEG required the complex setup of at least 20 electrodes with conductive gels, resulting in mostly short recordings confined to clinical settings. NAOX LINK now becomes the first in-ear EEG device cleared for clinical use in both home and healthcare environments, enabling more natural, longer-duration acquisition of brain electrical activity, according to the company. NAOX LINK takes advantage of the ability to record brain electrical activities with a device embedded into an ear plug.

“EEG readings have traditionally been constrained by short recording windows, uncomfortable headgear, and clinical settings that fail to reflect patients’ real lives,” Naox Technologies Co-Founder/CEO Hugo Dinh said. “With FDA clearance of NAOX LINK, clinicians can extend EEG into everyday environments, enabling longer, repeated more natural recordings and opening new possibilities for understanding brain activity beyond the clinic.”

Clinically Validated Technology

Cleared to acquire, record, and transmit electrical activity of the brain through a single-channel, non-invasive EEG, NAOX LINK uses soft, biocompatible in-ear electrodes integrated into a wired earbud design. The system is intended for use with adult and pediatric patients aged six and older and does not provide automated diagnostic conclusions.

After eight years of research across hardware miniaturization, signal processing, and clinical validation, NAOX is bringing EEG out of controlled labs and into real-world environments. NAOX’s technology has demonstrated strong correlation with a traditional low temporal EEG derivation to characterize sleep and neurological signals, as published in peer-reviewed journals.

By moving EEG acquisition from bulky scalp electrodes and gel-based setups to a comfortable in-ear format, NAOX LINK enables clinicians to capture brain activity during everyday life, sleep, daily routines, and real-world conditions that are often missed during traditional 20–30 minute in-clinic EEG sessions. It is built to support a range of clinical and research applications, including:

• Neurology and epilepsy care: Long-term and recurrent ambulatory EEG to complement short in-hospital recordings and increase the likelihood of capturing rare or intermittent events but also to monitor brain activities in the long range and capture the dynamics of neurological conditions
• Sleep medicine: Overnight EEG recordings conducted in the patient’s home, enabling more natural sleep assessment and staging, since brain is the main sleep organ
• Clinical research: Longitudinal brain monitoring in large cohorts, including pediatric and neurodegenerative research programs

Naox is already collaborating with European hospitals and research institutions, including Necker Hospital and the Rothschild Foundation Hospital on studies involving pediatric epilepsy and focal epilepsies of adult patients and epileptiform activity in patients at risk of Alzheimer’s disease. Following FDA clearance, the company plans to expand clinical partnerships in the United States.

“In most use cases, hospital EEG is mainly efficient in diseases diagnosis” stated Dr. Huberfeld (scientific advisor). “A comfortable in-ear system that works overnight and at home opens an entirely new window into brain function, one that may improve detection, monitoring, and understanding of neurological conditions. To be one step ahead of disease is a fantasy in medicine, even more so in neurology, and capturing the brain’s long-term dynamics is the first prerequisite.”

The FDA clearance was granted as the company uses CES 2026 (Las Vegas, Jan. 6-9) to showcase NAOX WAVE¹ and its vision for the future of brain health. Designed for general wellness rather than medical diagnosis, NAOX WAVE is not FDA-cleared and is positioned as both a consumer product and a scalable technology platform. It opens the door to future integration into true wireless earbuds and next-generation audio products, enabling OEM partners to add real brain-signal sensing to devices people already wear on a daily basis. This platform-based approach has the potential to reshape how millions of people engage with brain health and everyday mental wellness.

NAOX LINK (NX01) is currently available to selected U.S. neurology and sleep centers, with broader availability planned for 2026.

Founded in Paris in 2018, Naox Technologies develops medical-grade brain monitoring systems using miniaturized in-ear sensors and advanced signal processing. With extensive clinical research experience and partnerships across hospitals and academic institutions, Naox is focused on expanding access to high-quality EEG and enabling more natural, long-duration brain monitoring in both clinical and home settings.

Reference
¹ NAOX WAVE is intended for consumer wellness and lifestyle insights only and is not designed to diagnose, treat, cure, or prevent any disease.