Publications

BACKGROUND: Hearing loss is highly prevalent among older adults and has been associated with an increased likelihood of falling. We aimed to examine the effect of a hearing intervention on falls over 3 years among older adults in a secondary analysis of the ACHIEVE study.

METHODS: The Aging and Cognitive Health Evaluation in Elders (ACHIEVE) study was a 3-year, unmasked, randomised controlled trial of adults aged 70-84 years at enrolment with untreated hearing loss and without substantial cognitive impairment. Participants were recruited at four US community-based field sites from two study populations: (1) an ongoing observational study of cardiovascular health (Atherosclerosis Risk in Communities [ARIC] study), and (2) de novo from the community. Participants were randomly assigned (1:1) to a hearing intervention (audiological counselling and provision of hearing aids) or a health education control (didactic education and enrichment activities covering chronic disease prevention topics). A prespecified exploratory outcome was falls. Self-reported falls in the past 12 months were assessed at baseline and annually for 3 years, and analysed by intention to treat with covariate adjustment. The study was registered with ClinicalTrials.gov, NCT03243422, and is completed.

FINDINGS: Between Nov 9, 2017, and Oct 25, 2019, 3004 individuals were screened for eligibility and 977 (238 [24%] from the ARIC study and 739 [76%] de novo) were randomly assigned, with 490 (50%) in the hearing intervention group and 487 (50%) in the health education control group. Overall mean age was 76·8 years (SD 4·0), 523 (54%) participants were female and 454 (46%) were male, and 112 (11%) were Black, 858 (88%) were White, and seven (1%) were other race. In adjusted analyses, the intervention group had a 27% reduction in the mean number of falls over 3 years compared with the control group (intervention group: 1·45 [95% CI 1·28 to 1·61]; control group: 1·98 [1·82 to 2·15]; mean difference: -0·54 [95% CI -0·77 to -0·31]). This 3-year effect of hearing intervention was consistent across both the ARIC and de novo study populations.

INTERPRETATION: Hearing intervention versus a health education control was associated with a reduction in the mean number of falls over 3 years in older adults. Ongoing follow-up of ACHIEVE participants in a separate follow-up study (NCT05532657) will enable examination of the longer term effects of hearing intervention on falls.

FUNDING: US National Institutes of Health.

INTRODUCTION: Results from the Aging and Cognitive Health Evaluation in Elders (ACHIEVE) trial suggest hearing intervention may not reduce 3-year cognitive decline in all older adults with hearing loss but may be beneficial in certain groups. This secondary analysis investigated if participants with multiple risk factors for cognitive decline received greater benefits.

METHODS: We used a sample of dementia-free participants (N = 2692) from the Atherosclerosis Risk in Communities (ARIC) cohort to develop a predictive model for cognitive decline. The model was applied to baseline measures of ACHIEVE participants (N = 977) to estimate predicted risk. We tested an interaction between predicted risk and randomization to hearing intervention or health education control.

RESULTS: Among ACHIEVE participants in the top quartile of predicted risk, 3-year cognitive decline in the hearing intervention was 61.6% (95% confidence interval [CI]: 33.7%-94.1%) slower than the control.

DISCUSSION: The effect of hearing intervention on reducing 3-year cognitive decline was greatest among individuals with multiple baseline risk factors associated with faster cognitive decline.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03243422 HIGHLIGHTS: The Aging and Cognitive Health Evaluation in Elders (ACHIEVE) trial tested the effect of hearing intervention on cognitive decline. Participants were recruited from the Atherosclerosis Risk in Communities (ARIC) cohort or de novo from the local community. A 48% reduction in cognitive decline was observed in ARIC cohort participants. In this secondary analysis, there was an interaction between hearing intervention and predicted risk of cognitive decline. Among participants in the top quartile of predicted risk of cognitive decline, hearing intervention slowed cognitive decline by 62%.

Ototoxicity is among the adverse events related to cancer treatment that can have far-reaching consequences and negative impacts on quality-of-life for cancer patients and survivors of all ages. Ototoxicity management (OtoM) comprises the prevention, diagnosis, monitoring, and treatment, including rehabilitation and therapeutic intervention, of individuals who experience hearing loss, tinnitus, or balance/vestibular difficulties following exposures to ototoxic agents, including platinum chemotherapy (cisplatin, carboplatin) and cranial radiation. Despite the well-established physical, socioeconomic, and psychological consequences of hearing and balance dysfunction, there are no widely adopted standards for clinical management of cancer treatment-related ototoxicity. Consensus recommendations and a roadmap are needed to guide development of effective and feasible OtoM programs, direct research efforts, address the needs of caregivers and patients at all stages of cancer care and survivorship. Here we review current evidence and propose near-term to longer-term goals to advance OtoM in five strategic areas: (1) beneficiary awareness, empowerment, and engagement, (2) workforce enhancement, (3) program development, (4) policy, funding, and sustainability, and (5) research and evaluation. The goal is to identify needs and establish a roadmap to guide worldwide adoption of standardized OtoM for cancer treatment and improved outcomes for patients and survivors.

IMPORTANCE: Promoting social connection among older adults is a public health priority. Addressing hearing loss may reduce social isolation and loneliness among older adults.

OBJECTIVE: To describe the effect of a best-practice hearing intervention vs health education control on social isolation and loneliness over a 3-year period in the Aging and Cognitive Health Evaluation in Elders (ACHIEVE) study.

DESIGN, SETTING, AND PARTICIPANTS: This secondary analysis of a multicenter randomized controlled trial with 3-year follow-up was completed in 2022 and conducted at 4 field sites in the US (Forsyth County, North Carolina; Jackson, Mississippi; Minneapolis, Minnesota; Washington County, Maryland). Data were analyzed in 2024. Participants included 977 adults (aged 70-84 years who had untreated hearing loss without substantial cognitive impairment) recruited from the Atherosclerosis Risk in Communities study (238 [24.4%]) and newly recruited (de novo; 739 [75.6%]). Participants were randomized (1:1) to hearing intervention or health education control and followed up every 6 months.

INTERVENTIONS: Hearing intervention (4 sessions with certified study audiologist, hearing aids, counseling, and education) and health education control (4 sessions with a certified health educator on chronic disease, disability prevention).

MAIN OUTCOMES AND MEASURES: Social isolation (Cohen Social Network Index score) and loneliness (UCLA Loneliness Scale score) were exploratory outcomes measured at baseline and at 6 months and 1, 2, and 3 years postintervention. The intervention effect was estimated using a 2-level linear mixed-effects model under the intention-to-treat principle.

RESULTS: Among the 977 participants, the mean (SD) age was 76.3 (4.0) years; 523 (53.5%) were female, 112 (11.5%) were Black, 858 (87.8%) were White, and 521 (53.4%) had a Bachelor's degree or higher. The mean (SD) better-ear pure-tone average was 39.4 dB (6.9). Over 3 years, mean (SD) social network size reduced from 22.6 (11.1) to 21.3 (11.0) and 22.3 (10.2) to 19.8 (10.2) people over 2 weeks in the hearing intervention and health education control arms, respectively. In fully adjusted models, hearing intervention (vs health education control) reduced social isolation (social network size [difference, 1.05; 95% CI, 0.01-2.09], diversity [difference, 0.19; 95% CI, 0.02-0.36], embeddedness [difference, 0.27; 95% CI, 0.09-0.44], and reduced loneliness [difference, -0.94; 95% CI, -1.78 to -0.11]) over 3 years. Results were substantively unchanged in sensitivity analyses that incorporated models that were stratified by recruitment source, analyzed per protocol and complier average causal effect, or that varied covariate adjustment.

CONCLUSIONS AND RELEVANCE: This secondary analysis of a randomized clinical trial indicated that older adults with hearing loss retained 1 additional person in their social network relative to a health education control over 3 years. While statistically significant, it is unknown whether observed changes in social network are clinically meaningful, and loneliness measure changes do not represent clinically meaningful changes. Hearing intervention is a low-risk strategy that may help promote social connection among older adults.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03243422.

Objectives. To produce a database of private insurance hearing aid mandates in the United States and quantify the share of privately insured individuals covered by a mandate. Methods. We used health-related policy surveillance methods to create a database of private insurance hearing aid mandates through January 2023. We coded salient features of mandates and combined policy data with American Community Survey and Medicare Expenditure Panel Survey-Insurance Component data to estimate the share of privately insured US residents covered by a mandate from 2008 to 2022. Results. A total of 26 states and 1 territory had private insurance hearing aid mandates. We found variability for mandate exceptions, maximum age eligibility, allowable frequency of benefit use, and coverage amounts. Between 2008 and 2022 the proportion of privately insured youths (aged ≤ 18 years) living where there was a private insurance hearing aid mandate increased from 3.4% to 18.7% and the proportion of privately insured adults (19-64 years) increased from 0.3% to 4.6%. Conclusions. Hearing aid mandates cover a small share of US residents. Mandate exceptions in several states limit coverage, particularly for adults. Public Health Implications. A federal mandate would improve hearing aid access. States can also improve access by adopting exception-free mandates with limited utilization management and no age restrictions. (Am J Public Health. 2024;114(4):407-414. https://doi.org/10.2105/AJPH.2023.307551).

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.

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.

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.

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 (β = -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 (β = -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.

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.