First In-Ear EEG Device Gets FDA Clearance

Back to news list

Source: MedPage Today

Original: https://www.medpagetoday.com/neurology/generalneurology/119305...

Published: Tue, 06 Jan 2026 17:19:31 -0500

The FDA has approved Naox Technologies' NAOX LINK electroencephalography (EEG) system, which uses a small sensor in the ear to monitor patients outside the hospital.[1] The device consists of wired headphones with soft biocompatible electrodes in the earcups that capture a single channel of EEG data.[1][2] Data is uploaded and transmitted via a HIPAA-certified cloud platform to the physician for interpretation.[1] The system is intended for use under the supervision of licensed healthcare professionals in the home environment, healthcare facilities, or in clinical research.[1][2] It allows long-term EEG recordings of up to 10 hours, which helps in the detection of neurological and sleep disorders.[2] Signal quality correlates with traditional EEG methods, as confirmed by eight years of research published in peer-reviewed journals.[1] NAOX Buds complement existing devices, reduce wait times and increase patient autonomy in their care.[2]