Validation of a Self-Fitting Over-the-Counter Hearing Aid Intervention Compared with a Clinician-Fitted Hearing Aid Intervention: A Within-Subjects Crossover Design Using the Same Device

In October of 2022, the US Food and Drug Administration finalized regulations establishing the category of self-fitting over-the-counter (OTC) hearing aids, intended to reduce barriers to hearing aid adoption for individuals with self-perceived mild to moderate hearing loss. Since then a number of self-fitting OTC hearing aids have entered the market, and a small number of published studies have demonstrated the effectiveness of a self-fitted OTC intervention against a traditional clinician-fitted intervention. Given the variety of self-fitting approaches available, and the small number of studies demonstrating effectiveness, the goal of the present study was to evaluate the effectiveness of a commercially available self-fitting OTC hearing aid intervention against a clinician-fitted intervention. Consistent with previous studies, we found that the self-fitted intervention was not inferior to the clinician-fitted intervention for self-reported benefit and objective speech-in-noise outcomes. We found statistically significant improvements in self-fitted outcomes compared to clinician-fitted outcomes, though deviations from best audiological practices in our clinician-fitted intervention may have influenced our results. In addition to presenting our results, we discuss the state of evaluating the noninferiority of self-fitted interventions and offer some new perspectives.