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

Larry E Humes, Dana L Kinney, Anna K Main, Sara E Rogers, Larry E Humes, Dana L Kinney, Anna K Main, Sara E Rogers

Abstract

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://ichgcp.net/clinical-trials-registry/NCT01788423 Supplemental Material https://doi.org/10.23641/asha.7728479.

Figures

Figure 1.
Figure 1.
Means, ± 1 SD, for the unaided (X), aided (unfilled circles), and NAL-NL2 prescribed (filled circles) real-ear gain for the ears that chose the Z (placebo) hearing aid in follow-up consumer-decides groups. Top panel shows the data for the left ear and the bottom panel shows the data for the right ear. Speech presentation level was 65 dB SPL.
Figure 2.
Figure 2.
Audiograms for the 26 members of the CD2-CD (left) and the 14 members of the CD2-P (right) subgroups. Top panels show data for the left ears and bottom panels show data for the right ears. Large filled black circles show the median audiograms for the CD and P subgroups. The heavy solid lines in each panel show the limits for inclusion in the original clinical trial of Humes et al. (2017). CD = consumer-decides; CD2 = follow-up; P = placebo.
Figure 3.
Figure 3.
Mean (+1 SE) for the four main outcome measures common to both the CD1 (black bars) and CD2 (gray bars) cohorts. PHAB scores in the left panel should be referenced to the left ordinate, whereas CST and HHIE benefit scores in the right panel should be referenced to the right ordinate. Note that the right ordinate has been scaled by 1/100 to make it possible to plot all the benefit measures in the same figure. Small arrows pointing to ordinates reference the audiology-based means from Humes et al. (2017). The asterisk above the CST benefit scores indicates that this difference between the CD1 and CD2 cohorts was statistically significant (p < .05). CD = consumer-decides; CD1 = original CD; CD2 = follow-up CD; PHAB = Profile of Hearing Aid Benefit; CST = Connected Speech Test; HHIE = Hearing Handicap Inventory for the Elderly.
Figure 4.
Figure 4.
Mean (+1 SE) for the unaided and aided CST score, in rau, for the CD1 (black bars) and CD2 (gray bars) cohorts. The asterisk above the unaided CST scores indicates that this difference between the CD1 and CD2 cohorts was statistically significant (p < .05). rau = rationalized arcsine unit; CST = Connected Speech Test; CD1 = original consumer-decides; CD2 = follow-up consumer-decides.
Figure 5.
Figure 5.
The percentage of each group reporting each of the possible responses (abscissa) in response to the query, “Based on your experience in the trial, are you planning to keep the hearing aids?” The top panel compares the results between the CD1 (black) and CD2 (gray) studies, whereas the bottom panel compares the CD2-CD (black) and CD2-P (gray) subgroups. CD = consumer-decides; CD1 = original CD; CD2 = follow-up CD; P = placebo; HA = hearing aid.
Figure 6.
Figure 6.
Means (+1 SE) for the four main outcome measures for the 32 CD2 participants who completed the 4- to 5-week clinical trial (black bars) and the additional 4-week AB follow-up trial (gray bars). PHAB scores in the left panel should be referenced to the left ordinate, whereas CST and HHIE benefit scores in the right panel should be referenced to the right ordinate. Note that the right ordinate has been scaled by 1/100 to make it possible to plot all the benefit measures in the same figure. Small arrows pointing to ordinates reference the AB means from Humes et al. (2017). Asterisks above each pair of vertical bars indicate that the two groups differed significantly (p < .05) in performance for all four outcome measures. CD = consumer-decides; AB = audiology-based; CD2 = follow-up CD; PHAB = Profile of Hearing Aid Benefit; CST = Connected Speech Test; HHIE = Hearing Handicap Inventory for the Elderly.
Figure 7.
Figure 7.
Mean (+1 SE) for the four main outcome measures after the 4- to 5-week clinical trial (gray bars) and after the completion of the optional AB follow-up 4-week trial (black bars). PHAB scores are shown in the top panel, whereas CST and HHIE benefit scores appear in the bottom panel. In each panel, the CD2 data have been partitioned to display the results for the CD2-CD subgroup (left) and the CD2-P subgroup (right). Small arrows pointing to ordinates reference the AB means from Humes et al. (2017). AB = audiology-based; PHAB = Profile of Hearing Aid Benefit; CST = Connected Speech Test; HHIE = Hearing Handicap Inventory for the Elderly; CD = consumer-decides; CD2 = follow-up CD; P = placebo.
Figure 8.
Figure 8.
Mean (+1 SE) for the four main outcome measures common to both the ABCD (black bars) and CD2 (gray bars) studies. The data from the ABCD study are either for the CD group (left) or the group from Humes et al. (2017). PHAB scores are shown in the top panel, whereas CST and HHIE benefit scores appear in the bottom panel. In each panel, the CD2 data have been partitioned to display the results for the CD2-CD subgroup (left) and the CD2-P subgroup (right). Small arrows pointing to ordinates reference the AB means from Humes et al. (2017). The asterisk above the CST benefit scores indicates that this difference between the ABCD and CD2 cohorts was statistically significant (p < .05). CD = consumer-decides; CD2 = follow-up CD; P = placebo; PHAB = Profile of Hearing Aid Benefit; CST = Connected Speech Test; HHIE = Hearing Handicap Inventory for the Elderly.

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