Effect of hearing intervention on communicative function: A secondary analysis of the ACHIEVE randomized controlled trial.

BACKGROUND: The Aging and Cognitive Health Evaluation in Elders (ACHIEVE) Study was designed to determine the effects of a best-practice hearing intervention on cognitive decline among community-dwelling older adults. Here, we conducted a secondary analysis of the ACHIEVE Study to investigate the effect of hearing intervention on self-reported communicative function. METHODS: The ACHIEVE Study is a parallel-group, unmasked, randomized controlled trial of adults aged 70-84 years with untreated mild-to-moderate hearing loss and without substantial cognitive impairment. Participants were randomly assigned (1:1) to a hearing intervention (audiological counseling and provision of hearing aids) or a control intervention of health education (individual sessions with a health educator covering topics on chronic disease prevention) and followed semiannually for 3 years. Self-reported communicative function was measured with the Hearing Handicap Inventory-Elderly Screening version (HHIE-S, range 0-40, higher scores indicate greater impairment). Effect of hearing intervention versus control on HHIE-S was analyzed through an intention-to-treat model controlling for known covariates. RESULTS: HHIE-S improved after 6-months with hearing intervention compared to control, and continued to be better through 3-year follow-up. We estimated a difference of -8.9 (95% CI: -10.4, -7.5) points between intervention and control groups in change in HHIE-S score from baseline to 6 months, -9.3 (95% CI: -10.8, -7.9) to Year 1, -8.4 (95% CI: -9.8, -6.9) to Year 2, and - 9.5 (95% CI: -11.0, -8.0) to Year 3. Other prespecified sensitivity analyses that varied analytical parameters did not change the observed results. CONCLUSIONS: Hearing intervention improved self-reported communicative function compared to a control intervention within 6 months and with effects sustained through 3 years. These findings suggest that clinical recommendations for older adults with hearing loss should encourage hearing intervention that could benefit communicative function and potentially have positive downstream effects on other aspects of health.

Effect of Hearing Intervention Versus Health Education Control on Fatigue: A Secondary Analysis of the ACHIEVE Study.

BACKGROUND: Fatigue is a common complaint among older adults with hearing loss. The impact of addressing hearing loss on fatigue symptoms has not been studied in a randomized controlled trial. In a secondary analysis of the Aging and Cognitive Health Evaluation in Elders (ACHIEVE) study, we investigated the effect of hearing intervention versus health education control on 3-year change in fatigue in community-dwelling older adults with hearing loss. METHODS: Participants aged 70-84 years old with untreated hearing loss recruited across 4 study sites in the United States (Forsyth County, North Carolina; Jackson, Mississippi; Minneapolis, Minnesota; Washington County, Maryland) were randomized (1:1) to hearing intervention or health education control and followed for 3 years. Three-year change in fatigue symptoms was measured by 2 instruments (RAND-36 and PROMIS). We estimated the intervention effect as the difference in the 3-year change in fatigue between intervention and control groups using a linear mixed-effects model under the intention-to-treat principle. RESULTS: Participants (n = 977) had a mean age (SD) of 76.8 (4.0) years, were 53.5% female and 87.8% White. Over 3 years, a beneficial effect of the hearing intervention versus health education control on fatigue was observed using the RAND-fatigue score (ß = -0.12 [95% CI: -0.22, -0.02]). Estimates also suggested beneficial effect of hearing intervention on fatigue when measured by the PROMIS-fatigue score (ß = -0.32 [95% CI: -1.15, 0.51]). CONCLUSIONS: Our findings suggest that hearing intervention may reduce fatigue over 3 years among older adults with hearing loss.

A Perspective on Auditory Wellness: What It Is, Why It Is Important, and How It Can Be Managed.

During the last decade, there has been a move towards consumer-centric hearing healthcare. This is a direct result of technological advancements (e.g., merger of consumer grade hearing aids with consumer grade earphones creating a wide range of hearing devices) as well as policy changes (e.g., the U.S. Food and Drug Administration creating a new over-the-counter [OTC] hearing aid category). In addition to various direct-to-consumer (DTC) hearing devices available on the market, there are also several validated tools for the self-assessment of auditory function and the detection of ear disease, as well as tools for education about hearing loss, hearing devices, and communication strategies. Further, all can be made easily available to a wide range of people. This perspective provides a framework and identifies tools to improve and maintain optimal auditory wellness across the adult life course. A broadly available and accessible set of tools that can be made available on a digital platform to aid adults in the assessment and as needed, the improvement, of auditory wellness is discussed.

Hearing Impairment and Physical Activity and Physical Functioning in Older Adults: Baseline Results From the ACHIEVE Trial.

BACKGROUND: Hearing loss is associated with restricted physical activity (PA) and impaired physical functioning, yet the relationship between severity of hearing impairment (HI) and novel PA measures in older adults with untreated HI is not well understood. METHODS: Analyses included 845 participants aged ≥70 years (mean = 76.6 years) with a better-hearing ear pure-tone average (PTA) ≥30 and <70 dB in the Aging and Cognitive Health Evaluation in Elders (ACHIEVE) study who wore an ActiGraph accelerometer for 7 days. Physical functioning measures included grip strength and the Short Physical Performance Battery (SPPB). Linear regression models estimated the association by HI level (moderate or greater [PTA ≥ 40 dB] vs mild [PTA < 40 dB]) and continuous hearing with total daily activity counts, active minutes/day, activity fragmentation, grip strength, and gait speed. Logistic regression models estimated odds ratios (ORs) and 95% confidence intervals (CIs) of poor performance on the SPPB (≤6) and its subtests (≤2). Mixed-effects models estimated differences by HI level in activity by time of day. RESULTS: Participants with moderate or greater HI had poorer physical functioning, particularly balance (OR = 2.17, 95% CI = 1.29-3.67), versus those with mild impairment. There was no association of HI level with activity quantities or fragmentation. For diurnal patterns of activity, participants with moderate or greater HI had fewer activity counts in the afternoon (12:00 pm -05:59 pm). CONCLUSIONS: Older adults with worse hearing had shifted diurnal patterns and poorer balance performance. Exercise programs should be tailored to older adults with different levels of HI to maintain PA and physical functioning, particularly balance control.

Recruitment and baseline data of the Aging and Cognitive Health Evaluation in Elders (ACHIEVE) study: A randomized trial of a hearing loss intervention for reducing cognitive decline.

INTRODUCTION: Hearing loss is highly prevalent among older adults and independently associated with cognitive decline. The Aging and Cognitive Health Evaluation in Elders (ACHIEVE) study is a multicenter randomized control trial (partially nested within the infrastructure of an observational cohort study, the Atherosclerosis Risk in Communities [ARIC] study) to determine the efficacy of best-practice hearing treatment to reduce cognitive decline over 3 years. The goal of this paper is to describe the recruitment process and baseline results. METHODS: Multiple strategies were used to recruit community-dwelling 70-84-year-old participants with adult-onset hearing loss who were free of substantial cognitive impairment from the parent ARIC study and de novo from the surrounding communities into the trial. Participants completed telephone screening, an in-person hearing, vision, and cognitive screening, and a comprehensive hearing assessment to determine eligibility. RESULTS: Over a 24-month period, 3004 telephone screenings resulted in 2344 in-person hearing, vision, and cognition screenings and 1294 comprehensive hearing screenings. Among 1102 eligible, 977 were randomized into the trial (median age = 76.4 years; 53.5% female; 87.8% White; 53.3% held a Bachelor's degree or higher). Participants recruited through the ARIC study were recruited much earlier and were less likely to report hearing loss interfered with their quality of life relative to participants recruited de novo from the community. Minor differences in baseline hearing or health characteristics were found by recruitment route (i.e., ARIC study or de novo) and by study site. DISCUSSION: The ACHIEVE study successfully completed enrollment over 2 years that met originally projected rates of recruitment. Substantial operational and scientific efficiencies during study startup were achieved through embedding this trial within the infrastructure of a longstanding and well-established observational study. Highlights: The ACHIEVE study tests the effect of hearing intervention on cognitive decline.The study is partially nested within an existing cohort study.Over 2 years, 977 participants recruited and enrolled.Eligibility assessed by telephone and in-person for hearing, vision, and cognitive screening.The ACHIEVE study findings will have significant public health implications.

Description of the Baseline Audiologic Characteristics of the Participants Enrolled in the Aging and Cognitive Health Evaluation in Elders Study.

PURPOSE: The Aging and Cognitive Health Evaluation in Elders (ACHIEVE) study is a randomized clinical trial designed to determine the effects of a best-practice hearing intervention versus a successful aging health education control intervention on cognitive decline among community-dwelling older adults with untreated mild-to-moderate hearing loss. We describe the baseline audiologic characteristics of the ACHIEVE participants. METHOD: Participants aged 70-84 years (N = 977; Mage = 76.8) were enrolled at four U.S. sites through two recruitment routes: (a) an ongoing longitudinal study and (b) de novo through the community. Participants underwent diagnostic evaluation including otoscopy, tympanometry, pure-tone and speech audiometry, speech-in-noise testing, and provided self-reported hearing abilities. Baseline characteristics are reported as frequencies (percentages) for categorical variables or medians (interquartiles, Q1-Q3) for continuous variables. Between-groups comparisons were conducted using chi-square tests for categorical variables or Kruskal-Wallis test for continuous variables. Spearman correlations assessed relationships between measured hearing function and self-reported hearing handicap. RESULTS: The median four-frequency pure-tone average of the better ear was 39 dB HL, and the median speech-in-noise performance was a 6-dB SNR loss, indicating mild speech-in-noise difficulty. No clinically meaningful differences were found across sites. Significant differences in subjective measures were found for recruitment route. Expected correlations between hearing measurements and self-reported handicap were found. CONCLUSIONS: The extensive baseline audiologic characteristics reported here will inform future analyses examining associations between hearing loss and cognitive decline. The final ACHIEVE data set will be publicly available for use among the scientific community. SUPPLEMENTAL MATERIAL: https://doi.org/10.23641/asha.24756948.

Loneliness and Social Network Characteristics Among Older Adults With Hearing Loss in the ACHIEVE Study.

BACKGROUND: Hearing loss is linked to loneliness and social isolation, but evidence is typically based on self-reported hearing. This study quantifies the associations of objective and subjective hearing loss with loneliness and social network characteristics among older adults with untreated hearing loss. METHODS: This study uses baseline data (N = 933) from the Aging and Cognitive Health Evaluation in Elders (ACHIEVE) study. Hearing loss was quantified by the better ear, speech-frequency pure tone average (PTA), Quick Speech-in-Noise test, and hearing-related quality of life. Outcomes were validated measures of loneliness and social network characteristics. Associations were assessed by Poisson, negative binomial, and linear regression adjusted for demographic, health, and study design characteristics. RESULTS: Participants were mean of 76.8 (4.0) years, 54.0% female, and 87.6% White. Prevalence of loneliness was 38%. Worse PTA was associated with a 19% greater prevalence of moderate or greater loneliness (prevalence ration [PR]: 1.19.95% CI: 1.06, 1.33). Better speech-in-noise recognition was associated with greater social network characteristics (eg, larger social network size [IRR: 1.04, 95% CI: 1.00, 1.07]). Worse hearing-related quality of life was associated with a 29% greater prevalence of moderate or greater loneliness (PR: 1.29, 95% CI: 1.19, 1.39) and worse social network characteristics (eg, more constricted social network size [IRR: 0.96, 95% CI: 0.91, 1.00]). CONCLUSIONS: Results suggest the importance of multiple dimensions of hearing to loneliness and social connectedness. Hearing-related quality of life may be a potentially useful, easily administered clinical tool for identifying older adults with hearing loss associated with greater loneliness and social isolation.

Hearing loss and cognition: A protocol for ensuring speech understanding before neurocognitive assessment.

INTRODUCTION: Many neurocognitive evaluations involve auditory stimuli, yet there are no standard testing guidelines for individuals with hearing loss. The ensuring speech understanding (ESU) test was developed to confirm speech understanding and determine whether hearing accommodations are necessary for neurocognitive testing. METHODS: Hearing was assessed using audiometry. The probability of ESU test failure by hearing status was estimated in 2679 participants (mean age: 81.4 ± 4.6 years) using multivariate logistic regression. RESULTS: Only 2.2% (N = 58) of participants failed the ESU test. The probability of failure increased with hearing loss severity; similar results were observed for those with and without mild cognitive impairment or dementia. DISCUSSION: The ESU test is appropriate for individuals who have variable degrees of hearing loss and cognitive function. This test can be used prior to neurocognitive testing to help reduce the risk of hearing loss and compromised auditory access to speech stimuli causing poorer performance on neurocognitive evaluation.

Depression and Health-Related Quality of Life Among Older Adults With Hearing Loss in the ACHIEVE Study.

Hearing loss is associated with cognitive/physical health; less is known about mental health. We investigated associations between hearing loss severity, depression, and health-related quality of life among older adults with unaided hearing loss. Data (N = 948) were from the Aging and Cognitive Health Evaluation in Elders Study. Hearing was measured by pure-tone average (PTA), Quick Speech-in-Noise (QuickSIN) test, and the Hearing Handicap Inventory for the Elderly (HHIE-S). Outcomes were validated measures of depression and health-related quality of life. Associations were assessed by negative binomial regression. More severe hearing loss was associated with worse physical health-related quality of life (ratio: .98, 95% CI: .96, 1.00). Better QuickSIN was associated with higher mental health-related quality of life (1.01 [1.00, 1.02]). Worse HHIE-S was associated with depression (1.24 [1.16, 1.33]) and worse mental (.97 [.96, .98]) and physical (.95 [ .93, .96]) health-related quality of life. Further work will test effects of hearing intervention on mental health.

Hearing intervention versus health education control to reduce cognitive decline in older adults with hearing loss in the USA (ACHIEVE): a multicentre, randomised controlled trial.

BACKGROUND: Hearing loss is associated with increased cognitive decline and incident dementia in older adults. We aimed to investigate whether a hearing intervention could reduce cognitive decline in cognitively healthy older adults with hearing loss. METHODS: The ACHIEVE study is a multicentre, parallel-group, unmasked, randomised controlled trial of adults aged 70-84 years with untreated hearing loss and without substantial cognitive impairment that took place at four community study sites across the USA. Participants were recruited from two study populations at each site: (1) older adults participating in a long-standing observational study of cardiovascular health (Atherosclerosis Risk in Communities [ARIC] study), and (2) healthy de novo community volunteers. Participants were randomly assigned (1:1) to a hearing intervention (audiological counselling and provision of hearing aids) or a control intervention of health education (individual sessions with a health educator covering topics on chronic disease prevention) and followed up every 6 months. The primary endpoint was 3-year change in a global cognition standardised factor score from a comprehensive neurocognitive battery. Analysis was by intention to treat. This trial was registered at ClinicalTrials.gov, NCT03243422. FINDINGS: From Nov 9, 2017, to Oct 25, 2019, we screened 3004 participants for eligibility and randomly assigned 977 (32·5%; 238 [24%] from ARIC and 739 [76%] de novo). We randomly assigned 490 (50%) to the hearing intervention and 487 (50%) to the health education control. The cohort had a mean age of 76·8 years (SD 4·0), 523 (54%) were female, 454 (46%) were male, and most were White (n=858 [88%]). Participants from ARIC were older, had more risk factors for cognitive decline, and had lower baseline cognitive scores than those in the de novo cohort. In the primary analysis combining the ARIC and de novo cohorts, 3-year cognitive change (in SD units) was not significantly different between the hearing intervention and health education control groups (-0·200 [95% CI -0·256 to -0·144] in the hearing intervention group and -0·202 [-0·258 to -0·145] in the control group; difference 0·002 [-0·077 to 0·081]; p=0·96). However, a prespecified sensitivity analysis showed a significant difference in the effect of the hearing intervention on 3-year cognitive change between the ARIC and de novo cohorts (pinteraction=0·010). Other prespecified sensitivity analyses that varied analytical parameters used in the total cohort did not change the observed results. No significant adverse events attributed to the study were reported with either the hearing intervention or health education control. INTERPRETATION: The hearing intervention did not reduce 3-year cognitive decline in the primary analysis of the total cohort. However, a prespecified sensitivity analysis showed that the effect differed between the two study populations that comprised the cohort. These findings suggest that a hearing intervention might reduce cognitive change over 3 years in populations of older adults at increased risk for cognitive decline but not in populations at decreased risk for cognitive decline. FUNDING: US National Institutes of Health.

Feasibility and Assessment of a Hybrid Audiology Service Delivery Model for Older Adult Hearing Aid Users: A Pilot Study.

PURPOSE: The aim of this study was to provide insight for the feasibility and outcomes of hybrid (combination of in-person office and Internet-based appointments) audiology services. METHOD: This pilot included two phases. First, we surveyed audiologists regarding what elements of a best-practice, in-person delivery of a hearing intervention could be delivered via Internet-based appointments. Next, we piloted the feasibility and assessed outcomes of the procedures identified. Ten first-time hearing aid users aged 70 years and older were fit with Phonak Audeo M90-312T hearing aids. Two Internet-based follow-up appointments were completed using the myPhonak app. We administered the Hearing Handicap Inventory for the Elderly-Screening Version (HHIE-S), the Client Oriented Scale of Improvement (COSI), the Quick Speech-in-Noise Test (QuickSIN), and real-ear aided responses (REARs) to determine whether participants experienced improvements on hearing-related outcomes. The Telehealth Acceptance Questionnaire (TAQ) and the Visit-Specific Satisfaction Questionnaire (VSQ-9) were administered to gauge comfort with telehealth and satisfaction with Internet-based appointments. RESULTS: Survey results revealed that after an initial in-person appointment, nearly all follow-up hearing intervention components could be delivered remotely. We performed Wilcoxon signed-ranks tests to determine if the baseline and outcome results differed for outcomes. Baseline scores improved after 6 weeks (ps = .02 and. 005 for QuickSIN and HHIE-S) for speech-in-noise performance and self-perceived hearing difficulties. REARs from 500 to 4000 Hz measured after 6 weeks did not differ from baseline (ps = .612 and .398 for the right and left ears), suggesting no significant deviation from prescriptive targets because of remote fitting adjustments. All participants reported improvement in COSI goals after the intervention. TAQ results suggested that comfort with telehealth improved after attending Internet-based appointments (p = .005). VSQ-9 results revealed no differences in reported patient satisfaction between in-person and Internet-based appointments. CONCLUSIONS: We were able to develop a feasible hybrid audiology service delivery model for older adults. Our results enhance the evidence base for the implementation of telehealth audiology services.

Development, assessment, and monitoring of audiologic treatment fidelity in the aging and cognitive health evaluation in elders (ACHIEVE) randomised controlled trial.

OBJECTIVE: Studies investigating hearing interventions under-utilise and under-report treatment fidelity planning, implementation, and assessment. This represents a critical gap in the field that has the potential to impede advancements in the successful dissemination and implementation of interventions. Thus, our objective was to describe treatment fidelity planning and implementation for hearing intervention in the multi-site Ageing and Cognitive Health Evaluation in Elders (ACHIEVE) randomised controlled trial. DESIGN: Our treatment fidelity plan was based on a framework defined by the National Institutes of Health Behaviour Change Consortium (NIH BCC), and included strategies to enhance study design, provider training, and treatment delivery, receipt, and enactment. STUDY SAMPLE: To assess the fidelity of the ACHIEVE hearing intervention, we distributed a checklist containing criteria from each NIH BCC core treatment fidelity category to nine raters. RESULTS: The ACHIEVE hearing intervention fidelity plan satisfied 96% of NIH BCC criteria. Our assessment suggested a need for including clear, objective definitions of provider characteristics and non-treatment aspects of intervention delivery in future fidelity plans. CONCLUSIONS: The ACHIEVE hearing intervention fidelity plan can serve as a framework for the application of NIH BCC fidelity strategies for future studies and enhance the ability of researchers to reliably implement evidence-based interventions.

Factors Associated With Self-Perceived Hearing Handicap in Adults From Hispanic/Latino Background: Findings From the Hispanic Community Health Study/Study of Latinos.

OBJECTIVES: We sought to determine what factors, including acculturation (language and social contact preferences), were associated with self-perceived hearing handicap among adults from Hispanic/Latino background. We utilized the Aday-Andersen behavioral model of health services utilization to frame our hypotheses that predisposing characteristics (age, sex, education, city of residence, Hispanic/Latino background, and acculturation), enabling resources (annual income and current health insurance coverage), and need (measured hearing loss and self-reported hearing loss) would be related to clinically-significant self-perceived hearing handicap as measured by the Hearing Handicap Inventory - Screening (HHI-S) version. DESIGN: We analyzed baseline data collected from 2008 to 2011 as part of the multisite Hispanic Community Health Study/Study of Latinos. Data were from 6585 adults with hearing loss (defined by a worse-ear 500, 1000, 2000, and 4000 Hz pure-tone average [PTA] of ≥25 dB HL and/or a 4000, 6000, and 8000 Hz high-frequency PTA of ≥25 dB HL) aged 18 to 74 years from various Hispanic/Latino backgrounds. We conducted a series of multivariable logistic regression models examining the roles of independent variables of interest representing predisposing, enabling, and need indicators on the occurrence of clinically-significant self-perceived hearing handicap (e.g., HHI-S score > 8). RESULTS: Among included participants, 953 (14.5%) had an HHI-S score >8. The final model revealed significant associations between predisposing characteristics, enabling resources, need, and HHI-S outcome. Predisposing characteristics and need factors were associated with higher odds of reporting self-perceived hearing handicap (HHI-S score >8) including acculturation as measured by the Short Acculturation Scale for Hispanics (odds ratio [OR] = 1.28, 95% confidence interval [CI]: 1.09-1.50), female sex (OR = 1.72, 95% CI: 1.27-2.33), and poorer worse ear 500, 1000, 2000, and 4000 Hz PTA (OR = 1.02, 95% CI: 1.01-1.03); suggesting that a 5-decibel increase in a person's PTA was consistent with 10% higher odds of a HHI-S score of >8. Greater enabling resources were associated with lower odds of reporting clinically-significant self-perceived hearing handicap: compared with individuals with income <$10,000/year, the multivariable-adjusted OR among individuals with income $40,000 to $7500/year was 0.55 (95% CI: 0.33-0.89) and among individuals with income >$75,000/year was 0.28 (95% CI: 0.13-0.59]; p-trend < 0.0001). CONCLUSIONS: Our findings suggest there are associations between predisposing, enabling and need variables consistent with the Aday-Andersen model and self-perceived hearing handicap among adults from Hispanic/Latino background. The influence of language and culture on perceived hearing loss and associated handicap is complex, and deserves more attention in future studies. Our findings warrant further investigation into understanding the role of language and language access in hearing health care utilization and outcomes, as the current body of literature is small and shows mixed outcomes.

The Hearing Intervention for the Aging and Cognitive Health Evaluation in Elders Randomized Control Trial: Manualization and Feasibility Study.

OBJECTIVES: This work describes the development of a manualized best-practice hearing intervention for older adults participating in the Aging and Cognitive Health Evaluation in Elders (ACHIEVE) randomized controlled clinical trial. Manualization of interventions for clinical trials is critical for assuring intervention fidelity and quality, especially in large multisite studies. The multisite ACHIEVE randomized controlled trial is designed to assess the efficacy of a hearing intervention on rates of cognitive decline in older adults. We describe the development of the manualized hearing intervention through an iterative process that included addressing implementation questions through the completion of a feasibility study (ACHIEVE-Feasibility). DESIGN: Following published recommendations for manualized intervention development, an iterative process was used to define the ACHIEVE-hearing intervention elements and create an initial manual. The intervention was then delivered within the ACHIEVE-Feasibility study using one-group pre-post design appropriate for assessing questions related to implementation. Participants were recruited from the Tampa, Florida area between May 2015 and April 2016. Inclusion criteria were cognitively healthy adults aged 70 to 89 with symmetrical mild-to-moderately severe sensorineural hearing loss. The ACHIEVE-Feasibility study sought to assess the implementation of the manualized hearing intervention by: (1) confirming improvement in expected outcomes were achieved including aided speech-in-noise performance and perception of disease-specific self-report measures; (2) determining whether the participants would comply with the intervention including session attendance and use of hearing aids; and (3) determining whether the intervention sessions could be delivered within a reasonable timeframe. RESULTS: The initial manualized intervention that incorporated the identified best-practice elements was evaluated for feasibility among 21 eligible participants and 9 communication partners. Post-intervention expected outcomes were obtained with speech-in-noise performance results demonstrating a significant improvement under the aided condition and self-reported measures showing a significant reduction in self-perceived hearing handicap. Compliance was excellent, with 20 of the 21 participants (95.2%) completing all intervention sessions and 19 (90.4%) returning for the 6-month post-intervention visit. Furthermore, self-reported hearing aid compliance was >8 hr/day, and the average daily hearing aid use from datalogging was 7.8 hr. Study completion was delivered in a reasonable timeframe with visits ranging from 27 to 85 min per visit. Through an iterative process, the intervention elements were refined, and the accompanying manual was revised based on the ACHIEVE-Feasibility study activities, results, and clinician and participant informal feedback. CONCLUSION: The processes for the development of a manualized intervention described here provide guidance for future researchers who aim to examine the efficacy of approaches for the treatment of hearing loss in a clinical trial. The manualized ACHIEVE-Hearing Intervention provides a patient-centered, yet standardized, step-by-step process for comprehensive audiological assessment, goal setting, and treatment through the use of hearing aids, other hearing assistive technologies, counseling, and education aimed at supporting self-management of hearing loss. The ACHIEVE-Hearing Intervention is feasible in terms of implementation with respect to verified expected outcomes, compliance, and reasonable timeframe delivery. Our processes assure intervention fidelity and quality for use in the ACHIEVE randomized controlled trial (ClinicalTrials.gov Identifier: NCT03243422).

Hearing Aid Prevalence and Factors Related to Use Among Older Adults From the Hispanic Community Health Study/Study of Latinos.

Importance: Hearing loss is highly prevalent in the rapidly growing and aging Hispanic/Latino population in the United States. However, little is known or understood about hearing aid use among US adults from Hispanic/Latino backgrounds. Objective: To describe hearing aid prevalence and factors associated with hearing aid use among US adults of Hispanic/Latino backgrounds. Design, Setting, and Participants: Cross-sectional data were collected between 2008 and 2011 from 4 field centers (Bronx, New York; Chicago, Illinois; Miami, Florida; and San Diego, California) as part of the multisite Hispanic Community Health Study/Study of Latinos. Included individuals were adults aged 45 to 76 years with hearing loss (pure-tone average ≥25 dB HL) from randomly selected households in the 4 field centers and were from self-reported Hispanic/Latino backgrounds, including Central American, Cuban, Dominican, Mexican, Puerto Rican, South American, and mixed or other backgrounds. Analysis, including age- and background-weighted prevalence estimates and multivariate logistic regression using survey methodology, was conducted from 2017 to 2018. Main Outcomes and Measures: The primary outcome of interest was self-reported hearing aid use. The a priori hypothesis was that hearing aid prevalence estimates among included Hispanic/Latino adults would be less than recently published estimates of the general US population, and that poorer hearing, higher perceived need, older age, and higher acculturation would be associated with hearing aid use. Results: Of 1898 individuals with hearing loss, 1064 (56.1%) were men, and the mean (SE) age was 60.3 (0.3) years. A total of 87 (4.6%) included individuals reported hearing aid use. Increased odds of self-reported use was associated with poorer measured hearing (odds ratio [OR], 1.06; 95% CI, 1.03-1.09), higher Hearing Handicap Inventory-Screening scores (OR, 1.06; 95% CI, 1.03-1.08), access to health insurance coverage (OR, 2.30; 95% CI, 1.20-4.37), and place of residence (OR, 2.42; 95% CI, 1.17-5.02) in an adjusted logistic regression model. Conclusions and Relevance: Findings revealed underuse of hearing aids among adults from Hispanic/Latino backgrounds. A primary factor related to use was lack of health insurance, which suggests that access influenced hearing aid use. Changes to policy and clinical service provision are needed to increase hearing aid use among aging Hispanic/Latino adults in the United States.

Development of a hearing help-seeking questionnaire based on the theory of planned behavior.

OBJECTIVE: Our objective was to develop and assess a questionnaire measuring the constructs of the theory of planned behaviour (TPB) regarding older adults' behaviours towards seeking a hearing test. DESIGN: Older adults who failed a hearing screening completed a newly developed Theory of Planned Behavior-Hearing Help Seeking (TPB-HHS) questionnaire. A principal components analysis (PCA) examined the factor structure of the questionnaire, and a reliability analysis determined the internal consistency of the factors. An examination of six-month follow-up data determined whether the questionnaire differentiated between individuals who did and did not seek out a hearing test by comparing their TPB-HHS scores. STUDY SAMPLE: Participants were 407 adults aged 50 to 89 recruited at community hearing screenings. RESULTS: PCA and reliability analyses resulted in a 4-factor, 18 item questionnaire. Three of four factors demonstrated acceptable internal consistency. The TPB-HHS explained 60.18% of the variance and factors were interpreted to be measuring the constructs of Intentions, Perceived Behavioral Control, Attitudes, and Subjective Norms. Individuals who sought a hearing test scored significantly higher on the Intentions, Perceived Behavioral Control, and Attitudes scales than those who did not. CONCLUSIONS: The TPB-HHS provides insight into underlying psychological mechanisms that drive behaviours related to hearing help-seeking in older adults.

Development and Formative Assessment of the Hearing Loss Toolkit for Self-Management.

Hearing aids are a demonstrated efficacious intervention for age-related hearing loss, and research suggests that good hearing loss self-management skills improve amplification satisfaction and outcomes. One way to foster self-management skills is through the provision of patient education materials. However, many of the available resources related to the management of hearing loss do not account for health literacy and are not suitable for use with adults from varying health literacy backgrounds. To address this issue, we developed the Hearing Loss Toolkit for Self-Management as part of a manualized, best practices hearing intervention used in large clinical trial. We incorporated health literacy recommendations from the U.S. Department of Health and Human Services, the Centers for Disease Control and Prevention, and the Agency for Healthcare Research and Quality in a series of modules that address a variety of common problem areas reported by adults with hearing loss. A formative assessment consisting of feedback questionnaires, semistructured interviews, and a focus group session with representatives from the target audience was conducted. Findings from the development assessment process demonstrate that the Hearing Loss Toolkit for Self-Management is suitable for use with adults with age-related hearing loss who have varying health literacy backgrounds and abilities.

Hearing Screening in the Community.

BACKGROUND: Adults typically wait 7-10 yr after noticing hearing problems before seeking help, possibly because they are unaware of the extent of their impairment. Hearing screenings, frequently conducted at health fairs, community events, and retirement centers can increase this awareness. To our knowledge, there are no published studies in which testing conditions and outcomes have been examined for multiple "typical screening events." PURPOSE: The purpose of this article is to report hearing screening outcomes for pure tones and self-report screening tests and to examine their relationship with ambient noise levels in various screening environments. STUDY SAMPLE: One thousand nine hundred fifty-four individuals who completed a hearing screening at one of 191 community-based screening events that took place in the Portland, OR, and Tampa, FL, metro areas. DATA COLLECTION AND ANALYSIS: The data were collected during the recruitment phase of a large multisite study. All participants received a hearing screening that consisted of otoscopy, pure-tone screening, and completion of the Hearing Handicap Inventory-Screening Version (HHI-S). In addition, ambient sound pressure levels were measured just before pure-tone testing. RESULTS: Many more individuals failed the pure-tone screening (n = 1,238) and then failed the HHI-S (n = 796). The percentage of individuals who failed the pure-tone screening increased linearly with age from <20% for ages <45 yr to almost 100% for individuals aged ≥85 yr. On the other hand, the percentage of individuals who failed the HHI-S remained unchanged at approximately 40% for individuals aged ≥55 yr. Ambient noise levels varied considerably across the hearing screening locations. They impacted the pure-tone screen failure rate but not the HHI-S failure rate. CONCLUSIONS: It is important to select screening locations with a quiet space for pure-tone screening, use headphones with good passive attenuation, measure sound levels regularly during hearing screening events, halt testing if ambient noise levels are high, and/or alert individuals to the possibility of a false-positive screening failure. The data substantiate prior findings that the relationship between pure-tone sensitivity and reported hearing loss changes with age. Although it might be possible to develop age-specific HHI-S failure criteria to adjust for this, such an endeavor is not recommended because perceived difficulties are the best predictor of hearing health behaviors. Instead, it is proposed that a public health focus on education about hearing and hearing loss would be more effective.

Hearing treatment for reducing cognitive decline: Design and methods of the Aging and Cognitive Health Evaluation in Elders randomized controlled trial.

INTRODUCTION: Hearing impairment is highly prevalent and independently associated with cognitive decline. The Aging and Cognitive Health Evaluation in Elders study is a multicenter randomized controlled trial to determine efficacy of hearing treatment in reducing cognitive decline in older adults. Clinicaltrials.gov Identifier: NCT03243422. METHODS: Eight hundred fifty participants without dementia aged 70 to 84 years with mild-to-moderate hearing impairment recruited from four United States field sites and randomized 1:1 to a best-practices hearing intervention or health education control. Primary study outcome is 3-year change in global cognitive function. Secondary outcomes include domain-specific cognitive decline, incident dementia, brain structural changes on magnetic resonance imaging, health-related quality of life, physical and social function, and physical activity. RESULTS: Trial enrollment began January 4, 2018 and is ongoing. DISCUSSION: When completed in 2022, Aging and Cognitive Health Evaluation in Elders study should provide definitive evidence of the effect of hearing treatment versus education control on cognitive decline in community-dwelling older adults with mild-to-moderate hearing impairment.

A Randomized Controlled Trial to Evaluate Approaches to Auditory Rehabilitation for Blast-Exposed Veterans with Normal or Near-Normal Hearing Who Report Hearing Problems in Difficult Listening Situations.

BACKGROUND: Blast exposure is a major source of injury among Service members in the Iraq and Afghanistan conflicts. Many of these blast-exposed veterans report hearing-related problems such as difficulties understanding speech in noise and rapid speech, and following instructions and long conversations that are disproportionate to their measured peripheral hearing sensitivity. Evidence is mounting that these complaints result from damage to the central auditory processing system. PURPOSE: To evaluate the effectiveness of audiological rehabilitative interventions for blast-exposed veterans with normal or near-normal peripheral hearing and functional hearing difficulties. RESEARCH DESIGN: A randomized controlled trial with four intervention arms. STUDY SAMPLE: Ninety-nine blast-exposed veterans with normal or near-normal peripheral hearing who reported functional hearing difficulties. INTERVENTION: Four interventions were compared: compensatory communication strategies (CCS) education, CCS and use of a personal frequency modulation system (FM + CCS), CCS and use of an auditory training program (AT + CCS), and use of all three interventions combined (FM + AT + CCS). DATA COLLECTION AND ANALYSIS: All participants tested before, and immediately following an 8-week intervention period. The primary outcome measures upon which the study was powered assessed speech understanding in noise and self-reported psychosocial impacts of the intervention. In addition, auditory temporal processing, auditory working memory, allocation of attention, and hearing and cognitive self-report outcomes were assessed. RESULTS: Use of FM + CCS resulted in significant benefit for speech understanding in noise and self-reported hearing benefits, and FM + AT + CCS provided more self-reported cognitive benefits than FM + CCS, AT + CCS, or CCS. Further, individuals liked and reported using the FM system, but there was poor adherence to and high attrition among individuals assigned to receive AT. CONCLUSIONS: It is concluded that a FM system (or remote microphone via Bluetooth system) is an effective intervention for blast-exposed veterans with normal or near-normal hearing and functional hearing difficulties and should be routinely considered as an intervention approach for this population when possible.