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

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.

Clinical Effectiveness of an At-Home Auditory Training Program: A Randomized Controlled Trial.

OBJECTIVES: To investigate the effectiveness of an at-home frequent-word auditory training procedure for use with older adults with impaired hearing wearing their own hearing aids. DESIGN: Prospective, double-blind placebo-controlled randomized trial with three parallel branches: an intervention group who received the at-home auditory training; an active control group who listened to audiobooks using a similar platform at home (placebo intervention); and a passive control group who wore hearing aids and returned for outcomes, but received no intervention. Outcome measures were obtained after a 5-week period. A mixed research design was used with a between-subjects factor of group and a repeated-measures factor of time (pre- and post-treatment) to evaluate the effects of the at-home auditory training program. The intervention was completed in participants' own homes. Baseline and outcomes measures were assessed at a university research laboratory. The participants were adults, aged 54 to 80 years, with the mild-to-moderate hearing loss. Of the 51 identified eligible participants, 45 enrolled as a volunteer sample and 43 of these completed the study. Frequent-word auditory training regimen completed intervention at home over a period of 5 weeks. The active control group listened to audiobooks (placebo intervention) and the passive control group completed no intervention. The primary outcome measure is a Connected Speech test benefit. The secondary outcome measure is a 66-item self-report profile of hearing aid performance. RESULTS: Participants who received the at-home training intervention demonstrated significant improvements on aided recognition for trained materials, but no generalization of these benefits to nontrained materials was seen. This was despite reasonably good compliance with the at-home training regimen and careful verification of hearing aid function throughout the trial. Based on follow-up post-trial evaluation, the benefits observed for trained materials in the intervention group were sustained for a period of at least 8.5 months. No improvement was seen for supplemental outcome measures of hearing aid satisfaction, hearing handicap, or tolerance of background noise while listening to speech. CONCLUSIONS: The at-home auditory training procedure utilizing frequently occurring words was effective for the trained materials used in the procedure. No generalization was seen to nontrained materials or to perceived benefit from hearing aids.

The Acoustic Environments in Which Older Adults Wear Their Hearing Aids: Insights From Datalogging Sound Environment Classification.

PURPOSE: This report presents data on the acoustic environments in which older adults with age-related hearing loss wear their hearing aids. METHOD: This is an observational study providing descriptive data from 2 primary datasets: (a) 128 older adults wearing hearing aids for an average of 6 weeks and (b) 65 older adults wearing hearing aids for an average of 13 months. Acoustic environments were automatically and continuously classified about every 4 s, using the hearing aids' signal processing, into 1 of 7 acoustic environment categories. RESULTS: For both groups, older adults wore their hearing aids about 60% of the time in quiet or speech-only conditions. The automatic classification of sound environments was shown to be reliable over relatively short (6-week) and long (13-month) durations. Moreover, the results were shown to have some validity in that the obtained acoustic environment profiles matched a self-reported measure of social activity administered prior to hearing aid usage. For a subset of 56 older adults with data from both the 6-week and 13-month wear times, the daily amount of hearing aid usage diminished but the profile of sound environments frequented by the wearers remained stable. CONCLUSIONS: Examination of the results from the automatic classification of sound environments by the hearing aids of older adults provides reliable and valid environment classifications. The present data indicate that most such wearers choose generally favorable acoustic environments for hearing aid use.

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 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.

Lack of interaction between enzalutamide and warfarin in a metastatic castration-resistant prostate cancer patient.

Enzalutamide is an androgen receptor antagonist used for the treatment of metastatic castration-resistant prostate cancer. Enzalutamide is classified as a strong cytochrome P450 3A4 inducer, a moderate 2C9 and 2C19 inducer, and a time-dependent inducer of 1A2. Warfarin's more potent enantiomer is primarily metabolized by cytochrome P450 2C9 and has a narrow therapeutic window. Enzalutamide is thought to decrease therapeutic warfarin concentrations per pharmacokinetic studies performed during drug development. This case report describes a 59-year-old man undergoing treatment with enzalutamide for metastatic castration-resistant prostate cancer with a history of femoral vein thrombosis. The patient was receiving a total weekly warfarin dose of 37.5 mg prior to starting enzalutamide. Enzalutamide was initiated and warfarin continued at a constant dose without decrease in the patient's INR. The patient continued on enzalutamide and warfarin for 1 year without having any documented subtherapeutic INRs. This report illustrates one case in which the interaction between warfarin and enzalutamide was not clinically significant.