Date Published: March 1, 2017
Publisher: American Speech-Language-Hearing Association
Author(s): Larry E. Humes, Sara E. Rogers, Tera M. Quigley, Anna K. Main, Dana L. Kinney, Christine Herring.
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.
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.
Older adults from the general community were recruited via newspaper and community flyers to participate at a university research clinic.
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.
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 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.
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. 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%). Clinicaltrials.gov: NCT01788432; https://clinicaltrials.gov/ct2/show/NCT01788423 https://doi.org/10.23641/asha.5382499
This first-ever placebo-controlled double-blind randomized clinical trial of hearing aids in older adults with impaired hearing demonstrated the efficacy of the audiology best-practices approach (AB) to hearing aid provision. The outcomes obtained for the participants assigned to the AB treatment were significantly better than those obtained from the participants assigned to the placebo group (P). This was true for the primary outcome measure, PHABglobal; the secondary outcome measure, CST benefit; and other tertiary outcome measures as well (HHIE benefit, HASShaf). Medium or large effect sizes were observed for most of the outcome measures included in this clinical trial. The use of audiology best practices, including the individual evaluation and adjustment of the maximum power output of the hearing aids based on the listener’s uncomfortable loudness judgments, did not yield better perception of aversive or distorted sounds (PHABavds) compared to the placebo group. Further, daily usage was not impacted by service-delivery approach.
This single-site double-blind placebo-controlled randomized clinical trial is the first to demonstrate that hearing aids are efficacious in older adults for an audiology-based best-practices (AB) service-delivery model. The efficacy of an alternative OTC approach (CD) in which the consumer selected pre-programmed devices was also established. Overall, the CD model of OTC service delivery yielded only slightly poorer outcomes than the AB model. Nonetheless, outcomes for CD participants (as well as P participants) improved significantly following a 4-week AB-based follow-up trial. Purchase price, $600 versus $3,600 per pair of hearing aids, had no effect on outcomes, but a high percentage (85%) of those who rejected hearing aids paid the higher of the two prices for their devices. Efficacious OTC service-delivery models (and devices) may increase accessibility and affordability of hearing aids for millions of older adults, but further research is required to evaluate various devices and approaches, as well as to examine the generalization of the findings from this clinical trial.