A Follow-Up Clinical Trial Evaluating the Consumer-Decides Service Delivery Model

Objectives There were 2 main objectives. The primary objective was to replicate a prior clinical trial of a consumer-decides (CD) approach to selecting hearing aids in older adults as a potential model for over-the-counter (OTC) intervention using less front-end screening of participants and a wider range of frequency-gain characteristics in the devices. The 2nd objective, only feasible if participant choices allowed, was to evaluate the efficacy of the CD approach relative to a CD-based placebo device. Design The design of this study is a single-site, prospective, double-blind clinical trial. Outcome measures were obtained after a typical 4- to 5-week trial period. An optional follow-up of a 4-week audiology-based (AB) best practices trial was also included for replication and comparison purposes. Setting Older adults from the general community were recruited via newspaper and community flyers to participate at a university research clinic. Participants Participants were adults, aged 54-78 years, with mild-moderate hearing loss. Forty-one participants enrolled as a volunteer sample; 40 completed the intervention. Intervention(s) All participants received the same high-end digital mini-behind-the-ear hearing aids fitted bilaterally. CD participants self-selected their own preprogrammed hearing aids via an OTC-type model. One of the 3 devices from which participants could choose was programmed to be a placebo device with no functional gain. Primary and Secondary Outcome Measures The primary outcome measure is the 66-item self-report Profile of Hearing Aid Benefit ( Cox https://clinicaltrials.gov/ct2/show/NCT01788423 Supplemental Material https://doi.org/10.23641/asha.7728479.