Adult-onset hearing loss and incident cognitive impairment and dementia - A systematic review and meta-analysis of cohort studies.

BACKGROUND: We comprehensively summarized the cohort evidence to date on adult-onset hearing loss as risk factor for incident cognitive impairment and dementia, and examined the evidence for dose-response, risk for various dementia subtypes, and other moderators. Previous meta-analyses were less comprehensive. METHODS: We included cohort studies with participants without dementia and with hearing assessments at baseline, minimum 2 years follow-up and incident cognitive outcomes. We used random-effect models and subgroup and meta-regression on moderator analyses. RESULTS: We identified fifty studies (N=1,548,754). Hearing loss (yes/no) was associated with incident dementia risk (HR=1.35 [95% CI = 1.26 - 1.45), mild cognitive impairment (MCI HR=1.29 [95% CI = 1.11 - 1.50]), cognitive decline not specified as MCI or dementia (HR=1.29 [95% CI = 1.17 - 1.42]), and Alzheimer's disease dementia (ADD, HR=1.56 [95% CI = 1.30 - 1.87]), but not with vascular dementia (HR, 1.30 [95% CI = 0.83 - 2.05]). Each 10-decibel worsening of hearing was associated with a 16% increase in dementia risk (95% CI = 1.07 - 1.27). The effect of hearing loss did not vary across potential moderators. CONCLUSIONS: Cohort studies consistently support that adult-onset hearing loss increases the risk of incident cognitive decline, dementia, MCI, and ADD.

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.

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.

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 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.

Individual Life-Course Socioeconomic Position and Hearing Aid Use in the Atherosclerosis Risk in Communities Study.

BACKGROUND: To measure the association between individual life-course socioeconomic position (SEP) and hearing aid use, we examined childhood and adulthood socioeconomic variables collected at the Atherosclerosis Risk in Communities (ARIC) study baseline visit (1987-1989)/Life Course Socioeconomic Status study (2001-2002) and hearing aid use data collected at visit 6 (2016-2017). METHODS: ARIC is a prospective cohort study of older adults (45-64 years) recruited from 4 U.S. communities. This analysis included a subset of 2 470 participants with hearing loss at visit 6 (≥25 decibels hearing level [dB HL] better-ear) with complete hearing aid use data. Childhood SEP variables included parental education, parental occupation, and parental home ownership. Young and older adulthood SEP variables included income, education, occupation, and home ownership. Each life epoch was assigned a score ranging from 0 to 5 and then summed to calculate the individual cumulative SEP score. Multivariable-adjusted logistic regression was used to estimate the association between individual cumulative SEP and hearing aid use. Missing SEP scores were imputed for participants with incomplete socioeconomic data. RESULTS: Of the 2 470 participants in the analytic cohort (median [interquartile interval] age 79.9 [76.7-84.0], 1 330 [53.8%] women, 450 [18.2%] Black), 685 (27.7%) participants reported hearing aid use. Higher cumulative SEP was positively associated with hearing aid use (odds ratio [OR] = 1.09, 95% confidence interval [CI]: 1.04-1.14), and slightly stronger for childhood (OR = 1.09, 95% CI: 1.00-1.20) than older adulthood SEP score (OR = 1.06, 95% CI: 0.95-1.18). CONCLUSIONS: In this community-based cohort of older adults with hearing loss, higher individual life-course SEP was positively associated with hearing aid use.

Development and Critical Evaluation of a Condition-Specific Preference-Based Measure Sensitive to Binaural Hearing in Adults: The York Binaural Hearing-Related Quality-of-Life System.

OBJECTIVES: The widely-used generic preference-based measures of health-related quality of life-the EuroQol Descriptive System (EQ-5D) and the Health Utilities Index (HUI3)-are limited in their response to technologies that improve hearing. The EQ-5D lacks construct validity for hearing, while the HUI3 is restricted by a ceiling effect and by using speech reception as the only evidence of the ability to hear. Consequently, neither measure consistently registers benefits from binaural hearing, such as those from bilateral versus unilateral cochlear implantation. The objectives were to test whether informants value binaural hearing, to develop a condition-specific preference-based measure sensitive to binaural hearing, to assess the psychometric properties of the new instrument, and to determine whether it meets requirements for informing judgments of cost-effectiveness: does it measure greater gains than do the generic preference-based measures, while avoiding exaggerating losses, and displaying sensitivity to side effects? DESIGN: Three levels of function, ranging from no difficulty to great difficulty, were defined on each of three dimensions where listening is easier or more successful when hearing is binaural rather than monaural: perception of speech in spatially separated noise, localization of sounds, and effort and fatigue. Informants (N = 203) valued the 27 combinations of levels and dimensions in a time trade-off task with a 10-year time frame to provide a value of binaural-related quality of life ("binaural utility") for each combination. A questionnaire was compiled to allow respondents to report their level of function on each dimension so that a value of binaural utility could be assigned to them. The questionnaire and the age-standardized valuations constitute The York Binaural Hearing-Related Quality-of-Life System (YBHRQL). Adult users of unilateral implants (N = 8), bilateral implants (N = 11), or bimodal aiding (N = 9) undertook performance tests of spatial listening and completed the HUI3, EQ-5D, and Speech, Spatial, and Qualities of Hearing (SSQ) questionnaires. They completed the YBHRQL questionnaire 24 and 38 mo later. RESULTS: Despite long intervals between measurements, the YBHRQL demonstrated desirable psychometric properties: good construct validity evidenced by significant correlations with performance measures and the SSQ index; a greater ability than the EQ-5D or HUI3 to distinguish unilateral, bimodal, and bilateral listening; and good reproducibility. The YBHRQL did not exaggerate losses of utility but was insensitive to a potential side effect of implantation (pain/discomfort). It measured a gain in utility from bilateral compared with unilateral implantation (median = 0.11, interquartile range, 0.03 to 0.16) that was greater than the gain measured by the EQ-5D (0.00, 0.00 to 0.00) but not the HUI3 (0.00, 0.00 to 0.17). CONCLUSIONS: The YBHRQL summarizes the contribution of binaural hearing to quality of life by combining the functional status of a listener with the preferences of independent informants. It would be an efficient clinical outcome measure. In addition, if used alongside the EQ-5D or HUI3, it would provide evidence which could beneficially modulate confidence in the cost-effectiveness of interventions. Further research on its sensitivity to side effects, and on the size of the gains in utility which it measures, is needed to determine whether it could stand alone to inform resource-allocation decisions.

Association of Hearing Loss with Physical, Social, and Mental Activity Engagement.

This article aims to evaluate a hearing loss intervention versus an aging education intervention on activity engagement in the Aging and Cognitive Health Evaluation in Elders pilot (ACHIEVE-P). Forty adults (70-84 years) with hearing loss recruited from the Atherosclerosis Risk in Communities Study and de novo participated. Participants were randomized 1:1 to a best practices hearing intervention or a successful aging intervention. Hearing was measured with pure-tone audiometry. The Community Healthy Activities Model Program for Seniors questionnaire measured self-reported time engaging in activities at baseline and 6-month follow-up. At baseline, greater hearing loss was associated with reduced time per week on mental activities (-3.0 hours per 10 dB of hearing loss, 95% confidence interval: -5.8, -0.2). Mental activity engagement increased (mean: +1.3 hours, SD = 6.6) for the hearing intervention group but decreased (mean: -1.1 hours, SD = 4.8) for the aging education group (Cohen's d : 0.41). Hearing loss may be associated with reduced engagement in mental activities. Whether hearing loss treatment impacts activity will be studied in the full-scale ACHIEVE trial.

Prevalence of Asymmetric Hearing Among Adults in the United States.

OBJECTIVE: To estimate the national prevalence of asymmetric hearing among adults through applying two distinct audiometric criteria. STUDY DESIGN: National cross-sectional survey. SETTING: Ambulatory examination centers within the National Health and Nutrition Examination Survey (NHANES). PATIENTS: Non-institutionalized adults in the United States from the 2001 to 2012 cycles of NHANES aged 20 years and older with pure tone audiometric and tympanometric data (n = 6,190). INTERVENTION: Standardized protocol for pure tone audiometry and tympanometry. MAIN OUTCOME MEASURE: Proportion of asymmetric hearing according to two distinct audiometric criteria. One criterion (American Academy of Otolaryngology-Head and Neck Surgery [AAO-HNS]) specifies asymmetry as a difference between pure tone averages (PTA) greater than 15 dB, and the other (Veterans Affairs [VA]) specifies asymmetry as a difference greater than/equal to 20 dB across two contiguous frequencies or 10 dB across three contiguous frequencies. Analyses included sampling weights to account for the epidemiologic survey's complex sampling design. RESULTS: Using a definition from the AAO-HNS, overall prevalence was 2.77 and 9.46% when calculating the PTA with 0.5 to 4 kHz and 4 to 8 kHz, respectively. In contrast, through a working definition used within the VA, overall prevalence was 25.05% across 0.5 to 8 kHz. Estimates differed across sex and age, with men and older age cohorts exhibiting higher prevalence. CONCLUSIONS: A nationally-representative sample of US adults indicates higher prevalence of asymmetric hearing among men and older adult cohorts. There is currently no standard audiometric criterion for defining asymmetry, and prevalence estimates vary markedly depending on which audiometric criteria is used. Given the potentially high prevalence of asymmetry depending on criterion, clinicians should also consider other supplementary clinical data when recommending medical referral.

Hearing Loss, Hearing Aid Use, and Depressive Symptoms in Older Adults-Findings from the Atherosclerosis Risk in Communities Neurocognitive Study (ARIC-NCS).

OBJECTIVES: Investigate the cross-sectional association between hearing loss (HL), hearing aid use, and depressive symptoms in community-dwelling older adults. METHOD: The analytic sample consisted of 3,188 participants (age range 71-94 years) in the Atherosclerosis Risk in Communities Neurocognitive Study (ARIC-NCS). Multivariable logistic regression was used to evaluate the association of audiometric hearing status and self-reported hearing aid use with depressive symptoms (11-item Center for Epidemiologic Studies Depression scale). RESULTS: 4.6% of participants had depressive symptoms. Forty percent had mild HL and 27% had moderate or greater HL. In multivariable-adjusted models, mild HL was associated with 1.90 times higher odds (95% confidence interval [CI] 1.20-3.01) and moderate or greater HL with 2.42 times higher odds (95% CI 1.44-4.07) of depressive symptoms compared to normal hearing. Each 10dB increase in HL was associated with 1.30 higher odds of depressive symptoms (95% CI 1.14-1.49). Hearing aid use was not associated with depressive symptoms among those with mild (odds ratio [OR] 0.94, 95% CI 0.35-2.54) or moderate or greater (OR 1.12, 95% CI 0.60-2.11) HL. DISCUSSION: Older adults with HL have higher odds of depressive symptoms compared to adults with normal hearing. Future studies are needed to assess whether hearing care is protective against depressive symptoms in older adults.

Long-term Impact of Hearing Aid Provision or Cochlear Implantation on Hearing Handicap.

OBJECTIVES/HYPOTHESIS: Previous research has shown hearing handicap to be reduced following hearing aid use or cochlear implantation in short-to-medium follow-up periods, yet the impact of interventions for hearing loss on hearing handicap in the long term remains understudied. This article reports hearing handicap at 6 months, 12 months, and 5 years after either hearing aid provision or cochlear implantation. STUDY DESIGN: Observational study. METHODS: A study of 115 participants from the Studying Multiple Outcomes after Aural Rehabilitative Treatment (SMART) study cohort assessed self-reported hearing handicap using the Hearing Handicap Inventory for the Elderly Screening version (HHIE-S) at baseline, 6 months, 12 months, and 5 years. Generalized estimating equations (GEE) were used to estimate the population mean HHIE-S score over time, accounting for the correlated nature of repeated measures data, and multiple imputation with chained equations was performed to impute missing data. RESULTS: Compared to baseline, mean HHIE-S scores after hearing aid provision were significantly reduced at 6 months (mean = -7.96, 95% confidence interval [CI]: -10.40, -5.53), 12 months (mean = -6.58, 95% CI: -9.26, -3.90), and 5 years (mean = -4.58, 95% CI: -7.87, -1.30). After cochlear implantation, mean hearing handicap scores were also significantly lower compared to baseline at 6 months (mean = -8.18, 95% CI: -11.07, -5.30), 12 months (mean = -10.04, 95% CI: -12.92, -7.16), and 5 years (mean = -8.97, 95% CI: -12.92, -7.16). CONCLUSIONS: This study found short-term benefits from hearing aids and cochlear implantation on hearing handicap were maintained over 5 years. Laryngoscope, 131:1122-1126, 2021.

Long-term subjective loneliness in adults after hearing loss treatment.

Objective: While hearing loss is associated with loneliness, the long term impact of hearing loss interventions remains unknown. We investigated levels of loneliness in adults at baseline, 6-months, 1-year and 5-years after receiving a hearing aid (HA) or cochlear implant (CI). Design: In this 5-year follow-up to the Studying Multiple Outcomes after Aural Rehabilitative Treatment study, participants completed the University of California, Los Angeles (UCLA) Loneliness Scale at baseline, 6-months, 1-year, and 5-year time points. Generalized estimating equations modeled the population average UCLA score over time. Study Sample: Analytic cohort of 115 participants (74% of original 156) 50 years or older who received a HA or CI at baseline and completed at least one follow up visit. Results: Loneliness scores were not different at 5 years versus baseline for HA users. CI users showed significantly reduced loneliness at 6-months and 1-year from baseline and with no significant difference at 5 years. Conclusion: Over 5 years, we observed no increase in loneliness from baseline in a cohort of adults receiving HAs and CIs. Short-term reduction in loneliness in CI users was demonstrated. Future randomized trials are needed to definitively assess the impact of treated versus untreated hearing loss on loneliness.

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.