Study Design
AIDS
This randomized clinical effectiveness trial was conducted at the University of Pretoria, Pretoria, South Africa, between April 14 and August 29, 2022. The Humanities Research Ethics Committee at the University of Pretoria reviewed and approved the study protocol, and all participants provided written informed consent before participation. We followed the Consolidated Standards of Reporting Trials (Three research audiologists (including K.D.S.), each registered with the Health Professions Council of South Africa, were involved in performing the procedures. All participants were fitted with hearing aids bilaterally. Participants in the self-fitting group were provided self-fitting OTC hearing aids in their standard commercial packaging (Lexie Lumen [Lexie Hearing]) through the study audiologists.After the baseline evaluation to determine eligibility for participation, randomization was performed by the researcher using a random number generator. Hearing aid fitting was completed in a second session, and participants completed a 2-week field trial. During these 2 weeks, no assistance or fine-tuning via the Lexie remote support service was allowed for the self-fitting group nor was adjustment by the audiologist for the audiologist-fitted group. This design procedure isolated the benefit of fitting from the influence of online support on the self-fitting group participants. At the first follow-up, the audiologist conducted fine-tuning for the audiologist-fitted group on request. Participants in the self-fitting group were informed that they could contact remote support for troubleshooting or adjustment. After another 4-week field trial, the final assessments were conducted.