Abstract
ObjectivesThere 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.DesignThe 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.SettingOlder adults from the general community were recruited via newspaper and community flyers to participate at a university research clinic.ParticipantsParticipants 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 MeasuresThe 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.ResultsPer-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.ConclusionsPrior 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 RegistrationClinicaltrials.gov: NCT01788432; https://clinicaltrials.gov/ct2/show/NCT01788423Supplemental Materialhttps://doi.org/10.23641/asha.7728479
Highlights
As noted in the introduction, the original Humes et al (2017) randomized clinical trial had strict inclusion and exclusion criteria to make sure that all participants were viable candidates for the specific hearing aids used in that study and that there were no contraindications for the use of hearing aids
To determine whether this sample of participants was more heterogeneous audiometrically than the participants in the original clinical trial, we examined how many would have been eliminated from the original study for various reasons
This CD2 follow-up clinical trial yielded results for these 40 older adults that were in general agreement with those obtained from another sample (CD1) of 51 older adults in Humes et al (2017)
Summary
Due to self-selection of P devices by several participants, we will be able to compare the outcomes obtained here for non-P and P groups, all within the CD service delivery context, to further evaluate the efficacy of the CD approach, this time with a less screened study sample. This represents the second basic question to be addressed in this follow-up (CD2) clinical trial: Are the results from non-P self-fit devices (CD2-CD) superior to those from P self-fit devices (CD2-P) in this study, and what are the effect sizes observed? Given that audiology best practices represent the preferred method of hearing aid delivery (American Speech-LanguageHearing Association, 2015; Valente et al, 2006), as in Humes et al (2017), we asked how the outcomes for devices delivered with the CD method compared with established best practice service delivery
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
