Automated Measures of Speech Intelligibility Using Brain Wave Recordings

This study is set-up as a pre-market clinical investigation of a non-CE marked medical device. The main goal of the study is to measure the efficacy of the CORGEE software, a newly developed software application that will function as an added service in the auditory assessment and counselling by hearing care professionals for persons with (suspected) hearing-related problems. We will evaluate the efficacy and the clinical validity of the CORGEE software by means of a within-subject cross-sectional study in infants, toddlers, kindergartners and primary school children. The study will be carried out in 90 children with (suspected) hearing impairment. Participants are recruited via four participating sites (one university hospital and three ambulatory revalidation centers) across a period of 12 months. All participants will undergo an objective assessment of speech intelligibility based on electrophysiological responses to natural running speech, performed by their healthcare professional (HCP). Using the CORGEE device, neural tracking of the speech envelope will be investigated with and without hearing aids at different levels of speech intelligibility. With this clinical study, we aim to demonstrate an objective hearing aid benefit when listening to natural speech using EEG. Moreover, we aim to compare the objective results with behavioural measures of speech intelligibility obtained with standard-of-care assessments (speech audiometry). Additionally, by means of questionnaires we aim to determine the HCP's evaluation of the level of tolerance of the assessment for children, as well as the HCP's user experience and satisfaction with the CORGEE software. Finally, we will assess the usability of the CORGEE software as a counselling tool for persons with (suspected) hearing-related problems and their caregivers.