Naox Technologies has become the first medtech company to receive FDA clearance for its in-ear EEG device that can negate the need for complex and limited scalp electrodes that have been used for brain monitoring for decades.
Naox Link is an electroencephalography (EEG) platform that patients use via a small sensor worn in the ear, allowing brain activity to be monitored while they move around. According to a Jan. 6 release, the approach “enables long-duration, real-world brain monitoring beyond traditional hospital environments.”
The traditional approach wires patients with 20-plus electrodes, a setup that typically produces short recordings and confines monitoring to clinical settings.
Naox Link can be used in clinics, at home and in other healthcare settings, recording the brain’s electrical activity through a device embedded in an earplug.
“EEG readings have traditionally been constrained by short recording windows, uncomfortable headgear, and clinical settings that fail to reflect patients’ real lives,” said Hugo Dinh, co-founder and CEO of Naox Technologies, in the release.
“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.”
The device will be used for neurology and epilepsy care as well as for sleep monitoring and clinical research.
The Link is already being used in some neurology and sleep centers in the U.S., with “broader availability” planned for later this year, according to Naox. The device can be used in children 6 and older and in adults.
Naox is also developing a consumer-focused platform called Naox Wave, designed as a wellness product rather than for medical diagnoses.
While not yet FDA-cleared, the idea is for this device to be used with wireless earbuds and next-generation audio products, which could see companies “add real brain-signal sensing to devices people already wear every day,” according to the release.