By Clinical Research News Staff 

January 12, 2026 | A newly FDA-cleared in-ear electroencephalogram (EEG) device could significantly alter how neurological conditions are studied, screened, and monitored outside traditional clinical settings. Paris-based Naox Technologies announced at CES 2026 in Las Vegas that its medical-grade Naox Link system has received U.S. Food and Drug Administration (FDA) 510(k) clearance, positioning the novel tool for decentralized clinical research and real-world neurological data collection. 

Naox Link is designed to capture EEG signals from electrodes embedded in soft, biocompatible ear tips, allowing long-duration brain monitoring in home environments rather than hospitals. Unlike conventional ambulatory EEG systems, which rely on multiple scalp electrodes that can be uncomfortable and technically demanding, the in-ear form factor is intended to be self-applied by patients and worn continuously during daily life and sleep. This capability is particularly relevant for research into intermittent or nocturnal neurological events that are often missed during standard 20-minute EEG recordings. 

Clinical studies conducted to support FDA clearance focused on signal performance and usability rather than diagnostic claims. According to the company, three studies were required, including human factors testing to ensure that patients could correctly use the device without assistance. Two additional clinical studies evaluated whether neurologists could reliably recall epileptic spikes and seizures and the identification of sleep stages, such as REM and non-REM sleep. 

The research implications are substantial. Naox Technologies is already collaborating with U.S. and European partners on studies involving pediatric epilepsy, focal epilepsy in adults, and epileptiform activity in patients at risk of Alzheimer’s disease. Pediatric epilepsy was prioritized in part at the FDA’s request, reflecting the diagnostic challenges in children who may struggle to describe symptoms accurately. Beyond epilepsy, the device is being explored to study neurological activity during sleep, a period increasingly recognized as critical in conditions such as Alzheimer’s disease.  

To read the full story written by Deborah Borfitz, visit Diagnostics World News.