PP313 - Feasibility and Accuracy of Remote Hearing Evaluation for Over-the-Counter Hearing Aid Candidacy Determination

Abstract:
FDA regulations for over-the-counter hearing aids aimed to make devices affordable and accessible for Americans with mild-to-moderate hearing loss. Advances in health technologies, including remote hearing assessment, can support scalable delivery models that are affordable, convenient, and sustainable. The primary goals of this study were to evaluate a remote hearing evaluation approach and establish feasibility and accuracy in characterizing OTC hearing aid candidacy following remote evaluation. Our data show in-person results were significantly correlated with each response measure from the remote evaluation. This demonstrates the feasibility of using remote evaluation to accurately characterize OTC candidacy versus in-person clinical evaluation methods.

Summary:
In 2021, the World Health Organization estimated that 1 in 5, or about 1.5 billion people worldwide, have some degree of hearing loss. Untreated or late-diagnosed hearing loss has been linked to social isolation, loneliness, cognitive impairment, dementia, unemployment, and decline in general health, including increased rates of hospitalizations. These issues pose tremendous emotional and financial burden on individuals with hearing loss and the global healthcare system. For most adults experiencing hearing loss, hearing aids are the most common and effective intervention. In the fall of 2022, the United States Food and Drug Administration (FDA) issued final regulations for over-the-counter (OTC) hearing aids, aimed at making hearing aids more affordable and accessible for millions of Americans living with untreated mild-to-moderate hearing loss. Advances in digital health technologies, including remote hearing assessment, can support scalable hearing health delivery models that are affordable, convenient, and sustainable.

The primary goals of this study were: 1) To evaluate a remote hearing evaluation approach, which could provide a more convenient way to measure and assess hearing health; and 2) To establish the feasibility of accurately characterizing the OTC hearing aid candidacy of an individual following a remote hearing evaluation session with an audiologist. Subjects with varying degrees of hearing impairment completed two evaluation sessions, with each session completed by a different audiologist. One evaluation session was conducted remotely, where the subject completed a functional hearing loss questionnaire, an app-based pure tone test, an app-based speech-in-noise test, and an online consultation and characterization of hearing loss by an audiologist. In the other evaluation session, the subject was seen in-person, where the subject completed an intake questionnaire, otoscopy, air-conduction pure tone thresholds with a clinical audiometer, and hearing loss categorization following audiology best practice methods. For each participant, audiologists were blinded to hearing loss characterization from the other session.

Results show the Hearing Number derived from the clinical audiograms was significantly correlated with each response measure from the remote evaluation (functional hearing loss questionnaire, app-based pure tone test, and app-based speech-in-noise test). These results appear to demonstrate the feasibility of using a remote testing approach to accurately characterize the OTC candidacy and hearing health of individuals versus hearing loss characterization following typical in-person clinical evaluation methods. Future research directions include increasing the study sample size to provide more diversity in both demographics and hearing loss configurations/ severity, and further refinement of the remote hearing evaluation battery.