RP203 - Is a Cost-Effective, Limited-Services, Over-the-Counter Alternative Appropriate for Some Patients?

Abstract:
This study aimed to characterize the outcomes and potential outcome predictors of three different service-delivery models with the goal of facilitating accessible and affordable hearing healthcare. A double-blinded randomized controlled trial (RCT) design was used to randomize 249 adults with mild-to-moderate hearing loss into three service level groups. The levels of service included an OTC model, a limited-services hybrid model, and a full-service model. Participant in each group were also randomized to one of two hearing aid technology levels. The final study results and potential implications will be described. Results will also inform future optimization of hybrid service delivery models.

Summary:
Although OTCs are now available and are one group of important, accessible, and affordable hearing healthcare options, many questions remain unanswered. While studies have shown similar patient outcomes for a few OTC models when compared to Audiologists-based, full-service models; it is previously unknown whether these results could be replicated by a more rigorous randomized controlled trial (RCT). Further, it is unknown if it is possible to identify appropriate candidacy for different levels of service models, including whether a “hybrid” service-delivery model, in which professionals provide streamlined services to fit OTC amplification devices, can offer an affordable, quality, amplification intervention. The purpose of this study is to characterize the outcomes of three different service-delivery models with the goal of facilitating accessible and affordable hearing healthcare.

This double-blinded RCT randomized 249 adults with mild-to-moderate hearing loss into three service level groups, at two different sites that differed geographically and by population density (University of Iowa, Vanderbilt University Medical Center). The levels of service included: 1) An OTC model which required participants to take full responsibility for learning and using amplification with the support of print and online materials modified for this project; 2) A hybrid, “OTC+” model which added basic evaluation, selection and orientation services provided by a professional; and 3) An “AUD” model providing best practices, audiologist-based, professional hearing aid services. Participant in each group were also randomized into one of two device groups: 1) An entry level hearing aid (features similar to current mid-level OTC devices); and 2) A premium level hearing aid from the same manufacturer. All participants were blinded to all other service levels. In addition, device level was obscured by replacing device names in support and fitting materials with generic names. The hearing aids were configured to have four, fixed, frequency responses encompassing those appropriate for listeners with mild-to-moderate hearing loss (Wu et al., 2020) for the OTC and OTC+ models. Conversely, participants in the AUD arm were fitted to individualized prescriptive gain targets using probe microphone techniques. All participants were initially evaluated on a variety of personal characteristics and predictive variables including cognition, working memory, personality, quality of life, and locus of control. Hearing aid outcomes were assessed during and after a seven-week field trial including an Ecological Momentary Assessment (EMA) based delivery of the Glasgow Hearing Aid Benefit Profile (GHABP) delivered by smartphone during the seventh week of the trial.

The final study results comparing outcomes across service-delivery models and level of hearing aid technology; as well as some potential implications of these findings, will be described. Analysis of the preliminary results suggests significant differences in outcomes across the service models, irrespective of hearing aid technology level. Preliminary results also revealed that our predictive variables were significantly related to outcomes, but only for a sub-set of the service delivery models and one hearing aid technology level. Based on the preliminary data, the final study results are also expected to inform the optimization of hybrid service delivery models with regard to benefits and limitations.