A Follow-Up Clinical Trial Evaluating the Consumer-Decides Service Delivery Model
Authors: Humes Larry E. , Kinney Dana L. , Main Anna K. , Rogers Sara E. 
Published: February 2019

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 & Alexander, 1990
). The secondary outcome measure is the Connected Speech Test (
Cox, Alexander, & Gilmore, 1987
) benefit. Additional measures of hearing aid benefit and usage were also obtained.

Results
Per-protocol analyses based on the data from the 40 (of 41) participants who completed the study were performed. Hearing aid outcomes from this follow-up CD (CD2) cohort were positive and generally the same as for the original CD cohort. CD service delivery model was efficacious relative to CD-based placebo control, with medium effect sizes observed. Approximately half of the CD2 group was likely to purchase hearing aids after the trial, similar to findings for the original CD cohort. Outcomes improved significantly for the 32 CD2 participants who elected to complete the optional 4-week AB trial. For this largely unscreened sample, more individuals with healthy hearing sought amplification, and many of these individuals (35%) chose placebo devices for both ears.

Conclusions
Prior positive outcomes for CD service delivery have been replicated in a less restrictive approach to participant recruitment. The CD approach was again found to be efficacious. Significantly better outcomes were observed after subsequent AB service delivery follow-up, also replicating prior findings. Efficacious OTC models, including those using similar CD approaches to hearing aid self-selection, may increase accessibility and affordability of hearing aids for millions of older adults. Front-end guidance to consumers regarding the best path to intervention, ranging from self-screening of hearing online to a full audiologic assessment, appears to be critical to optimize the success of OTC approaches.

Trial Registration
Clinicaltrials.gov: NCT01788432; https://clinicaltrials.gov/ct2/show/NCT01788423

Supplemental Material

https://doi.org/10.23641/asha.7728479