The Effects of Service-Delivery Model and Purchase Price on Hearing-Aid Outcomes in Older Adults: A Randomized Double-Blind Placebo-Controlled Clinical Trial Objectives The objectives of this study were to determine efficacy of hearing aids in older adults using audiology best practices, to evaluate the efficacy of an alternative over-the-counter (OTC) intervention, and to examine the influence of purchase price on outcomes for both service-delivery models. Design The design of ... Research Article
Research Article  |   March 01, 2017
The Effects of Service-Delivery Model and Purchase Price on Hearing-Aid Outcomes in Older Adults: A Randomized Double-Blind Placebo-Controlled Clinical Trial
 
Author Affiliations & Notes
  • Larry E. Humes
    Department of Speech and Hearing Sciences, Indiana University, Bloomington
  • Sara E. Rogers
    Department of Speech and Hearing Sciences, Indiana University, Bloomington
  • Tera M. Quigley
    Department of Speech and Hearing Sciences, Indiana University, Bloomington
  • Anna K. Main
    Department of Speech and Hearing Sciences, Indiana University, Bloomington
  • Dana L. Kinney
    Department of Speech and Hearing Sciences, Indiana University, Bloomington
  • Christine Herring
    Department of Speech and Hearing Sciences, Indiana University, Bloomington
  • Disclosure: The authors have declared that no competing interests existed at the time of publication. No funding was received from GN ReSound in support of this trial, and all hearing aids were purchased from the manufacturer in large quantities at a price of $100 per hearing aid.
    Disclosure: The authors have declared that no competing interests existed at the time of publication. No funding was received from GN ReSound in support of this trial, and all hearing aids were purchased from the manufacturer in large quantities at a price of $100 per hearing aid. ×
  • Correspondence to Larry E. Humes: humes@indiana.edu
  • Editor: Sumitrajit Dhar
    Editor: Sumitrajit Dhar×
Article Information
Hearing Disorders / Hearing Aids, Cochlear Implants & Assistive Technology / Special Populations / Older Adults & Aging / Research Articles
Research Article   |   March 01, 2017
The Effects of Service-Delivery Model and Purchase Price on Hearing-Aid Outcomes in Older Adults: A Randomized Double-Blind Placebo-Controlled Clinical Trial
American Journal of Audiology, March 2017, Vol. 26, 53-79. doi:10.1044/2017_AJA-16-0111
History: Received February 7, 2016 , Revised January 10, 2017 , Accepted January 13, 2017
 
American Journal of Audiology, March 2017, Vol. 26, 53-79. doi:10.1044/2017_AJA-16-0111
History: Received February 7, 2016; Revised January 10, 2017; Accepted January 13, 2017
Web of Science® Times Cited: 13

Objectives The objectives of this study were to determine efficacy of hearing aids in older adults using audiology best practices, to evaluate the efficacy of an alternative over-the-counter (OTC) intervention, and to examine the influence of purchase price on outcomes for both service-delivery models.

Design The design of this study was a single-site, prospective, double-blind placebo-controlled randomized trial with three parallel branches: (a) audiology best practices (AB), (b) consumer decides OTC model (CD), and (c) placebo devices (P). Outcome measures were obtained after a typical 6-week trial period with follow-up 4-week AB-based trial for those initially assigned to CD and P groups.

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, ages 55–79 years, with mild-to-moderate hearing loss. There were 188 eligible participants: 163 enrolled as a volunteer sample, and 154 completed the intervention.

Intervention(s) All participants received the same high-end digital mini-behind-the-ear hearing aids fitted bilaterally. AB and P groups received best-practice services from audiologists; differing mainly in use of appropriate (AB) or placebo (P) hearing aid settings. CD participants self-selected their own pre-programmed hearing aids via an OTC model.

Primary and Secondary Outcome Measures Primary outcome measure was a 66-item self-report, Profile of Hearing Aid Benefit (Cox & Gilmore, 1990). Secondary outcome measure was the Connected Speech Test (Cox, Alexander, & Gilmore, 1987) benefit. Additional measures of hearing-aid benefit, satisfaction, and usage were also obtained.

Results Per-protocol analyses were performed. AB service-delivery model was found to be efficacious for most of the outcome measures, with moderate or large effect sizes (Cohen's d). CD service-delivery model was efficacious, with similar effect sizes. However, CD group had a significantly (p < .05) lower satisfaction and percentage (CD: 55%; AB: 81%; P: 36%) likely to purchase hearing aids after the trial.

Conclusions Hearing aids are efficacious in older adults for both AB and CD service-delivery models. CD model of OTC service delivery yielded only slightly poorer outcomes than the AB model. Efficacious OTC models may increase accessibility and affordability of hearing aids for millions of older adults. Purchase price had no effect on outcomes, but a high percentage of those who rejected hearing aids paid the typical price (85%).

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

Supplemental Materials https://doi.org/10.23641/asha.5382499

Acknowledgments
This trial was supported by a research grant to Larry E. Humes from the NIDCD, R01 DC011771. No funding was received from GN ReSound in support of this trial, and all hearing aids were purchased from the manufacturer in large quantities at a price of $100 per hearing aid.
We thank Kimberly Skinner, AuD, for some assistance with data collection and Stephanie Dickinson for help with statistical analyses. We also thank Laurel Christensen, Andree Girard, Jennifer Groth, Dena Sloan-Gordon, and Tammy Stender for their assistance with study hearing aid programming and technical support.
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