Clinical use cases for Naox Link currently being investigated with partners in the U.S. include pediatric epilepsy and Alzheimer’s disease, Letombe says. Other studies underway are focused more on easing the logistical challenges of getting an in-office EEG by shipping the earbud version to patients for screening ahead of their appointment with a neurologist.
Unlike an ECG, it is impossible to do an EEG using a smartwatch because it sits too far from the brain to pick up the electric signals it generates. Those signals are roughly 1,000 times smaller than heart signals, he says, so the recording device needs to be near the brain. The raw data also needs specialized analysis.
Two years later, the company secured venture capital funding from French investors to launch clinical trials for epilepsy and advance their miniaturized EEG sensor technology, Letombe reports. For the past two years, it has been conducting studies to evaluate the signal quality of the in-ear device against gold-standard scalp EEG equipment.
FDA clearance required three studies, including human factors testing, to ensure intended users would be able to follow instructions for using the device without outside assistance. Another two clinical studies were done to demonstrate it Naox Link could recall epileptic spikes and seizures from patients with epilepsy and to identify different sleep stages, including the three non-rapid eye movement stages known as N1, N2, and N3 as well as REM sleep.
Additionally, the company was able to confirm that the dozens of signals from hundreds of patients were understood by neurologists presented with the data. While the device is not cleared to identify seizures or sleep stages, it provides the signals required by medical specialists to do so, Letombe says.
FDA clearance was the first regulatory goal, since the U.S. represents the biggest market for Naox Link, he says. But the next step is to get the CE mark in Europe, which is expected within the next three months.
The device is already being used at three major hospitals in France on studies involving pediatric epilepsy and focal epilepsies of adult patients and epileptiform activity in patients at risk of Alzheimer’s disease, and these will now expand to the U.S. The focus on children was based on a request from the FDA, given the difficulty in diagnosing epilepsy in suffering youngsters unable to adequately describe their symptoms, Letombe says.
The Naox Link device itself is one size that fits all. But the ear tips come in four sizes ranging from extra small to large to accommodate ear canals of every dimension.
Feedback to date from neurologists using the Naox Link has been uniformly positive, says Letombe, which is easy to understand. Not only are there no logistical complications, but the cost of in-ear technology is about 20 times cheaper than an in-hospital EEG and theoretically could be reused indefinitely. For hygiene and signal quality, only the eartips need to be changed when the device is being repurposed for a new user. As with any electronic device, it also needs periodic recharging.
For its intended medical applications, individuals aren’t expected to need the in-ear EEG system for more than two to four weeks, he adds. All signals worth capturing happen within that period, including times when people are sleeping, on vacation, or have just consumed a big meal or a lot of alcohol.
Many clinical conditions require brain-signal monitoring during sleep, including seizures associated with epilepsy, says Letombe. “About 30% of people with a predisposition for Alzheimer’s have seizures while they sleep and don’t know about it,” he adds.
This is in fact the subject of one ongoing research study designed to shed light on how Alzheimer’s works. There is also some preliminary evidence that anti-epileptic medicines might slow or reverse development of the disease, notes Letombe, “because if you help people avoid seizure when they’re asleep, obviously their brain is getting better.”
Naox Technologies is working with pharma companies and contract research organizations on ways to improve their clinical studies for anti-epileptic medications and other brain-targeting drugs. Although EEG monitoring can help de-risk trials, it is concerningly underutilized. Many medications are potentially seizure-causing, Letombe says.
Sponsors of decentralized trials are among the initial markets targeted for Naox Link. That could grow to include AI companies who could use all the EEG data that’s being amassed to automate and improve diagnoses of conditions like epilepsy, sleep disorders, and dementia as well as personalize treatment.
Meanwhile, Naox Technologies is working with several major commercial Bluetooth-based earbud brands to integrate the consumer-grade EEG capabilities of Wave into their product lines. This will initially be for wellness measurements such as focus, relaxation, and alertness, as well as “individual electroencephalography” as a yardstick of cognitive performance.
With Noax Link, users don’t receive any feedback other than confirmation that the signal quality is good, the battery is sufficiently charged, and they’re connected to the cloud. The neurologist on the other end reviews the EEG signals coming off the device, in some cases aided by AI in interpreting the extensive, real-world recordings.