Naox Technologies receives FDA 510(k) clearance for NAOX LINK in-ear EEG system
single-channel device is cleared to acquire, record, and transmit EEG data for clinical use in home and healthcare settings for patients ages 6 and older.
Naox Technologies has received U.S. Food and Drug Administration (FDA) 510(k) clearance for NAOX LINK (NX01), an in-ear electroencephalography (EEG) system intended for clinical use in both home and healthcare environments.
According to a release by the compnay, NAOX LINK is designed to acquire, record, and transmit electrical activity of the brain using non-invasive, in-ear electrodes integrated into a wired earbud-style form factor. The company said the system records a single EEG channel, is intended for adult and pediatric patients ages six and older, and does not provide automated diagnostic conclusions.
“EEG recordings have often been limited by short recording windows and clinical environments,” said Hugo Dinh, co-founder and CEO of Naox Technologies. “With FDA clearance for NAOX LINK, clinicians can extend EEG acquisition into everyday environments and collect longer and repeated recordings.”
Intended use and potential applications
Naox said the in-ear approach is designed to support longer-duration EEG monitoring during daily routines and sleep, including settings outside traditional hospital-based testing. The company said NAOX LINK is built to support clinical and research use cases such as:
- Neurology and epilepsy care: Longer-duration and repeat ambulatory EEG recordings intended to complement short in-clinic or in-hospital recordings and support monitoring over time
- Sleep medicine: Overnight EEG recordings conducted in the patient’s home to support sleep assessment and staging
- Clinical research: Longitudinal monitoring in larger cohorts, including pediatric and neurodegenerative research programs
Research and clinical collaborations
Naox said it has collaborated with European hospitals and research institutions including Necker Hospital and the Rothschild Foundation Hospital on studies involving pediatric epilepsy, focal epilepsies in adults, and epileptiform activity in patients at risk of Alzheimer’s disease. Following FDA clearance, the company said it plans to expand clinical partnerships in the United States.
“In many cases, hospital EEG is primarily used for diagnosis,” said Dr. Huberfeld, a scientific advisor to the company. “A comfortable in-ear system that can be used overnight and at home may provide additional opportunities to monitor brain activity over longer periods.”
CES and wellness product line
Naox said the FDA clearance coincides with its presence at CES, where it plans to showcase NAOX WAVE, which the company describes as a general wellness product and platform. Naox said NAOX WAVE is not FDA-cleared and is not intended for medical diagnosis.
Availability
Naox said NAOX LINK is currently available to selected neurology and sleep centers in the United States, with broader availability planned for 2026.
Healthcare professionals and research institutions interested in pilot programs or clinical collaboration can contact marc@naox.tech or visit naox.tech.
