RESUMO
Objective. The primary objective of this study was to evaluate the reliability, comfort, and performance of a custom-fit, non-invasive long-term electrophysiologic headphone, known as Aware Hearable, for the ambulatory recording of brain activities. These recordings play a crucial role in diagnosing neurological disorders such as epilepsy and in studying neural dynamics during daily activities.Approach.The study uses commercial manufacturing processes common to the hearing aid industry, such as 3D scanning, computer-aided design modeling, and 3D printing. These processes enable the creation of the Aware Hearable with a personalized, custom-fit, thereby ensuring complete and consistent contact with the inner surfaces of the ear for high-quality data recordings. Additionally, the study employs a machine learning data analysis approach to validate the recordings produced by Aware Hearable, by comparing them to the gold standard intracranial electroencephalography recordings in epilepsy patients.Main results.The results indicate the potential of Aware Hearable to expedite the diagnosis of epilepsy by enabling extended periods of ambulatory recording.Significance.This offers significant reductions in burden to patients and their families. Furthermore, the device's utility may extend to a broader spectrum, making it suitable for other applications involving neurophysiological recordings in real-world settings.
