Randomized Controlled Trial

. 2025 Jun;10(6):e492-e502.

doi: 10.1016/S2468-2667(25)00088-X.

Effects of hearing intervention on falls in older adults: findings from a secondary analysis of the ACHIEVE randomised controlled trial

Adele M Goman¹, Nasya Tan², James Russell Pike³, Sarah Y Bessen⁴, Ziheng Sally Chen⁵, Alison R Huang⁶, Michelle L Arnold⁷, Sheila Burgard⁸, Theresa H Chisolm⁷, David Couper⁸, Jennifer A Deal⁹, Nancy W Glynn¹⁰, Theresa Gmelin¹⁰, Lisa Gravens-Mueller⁸, Kathleen M Hayden¹¹, Pablo Martinez-Amezcua⁹, Christine M Mitchell¹², James S Pankow¹³, Nicholas S Reed¹⁴, Victoria A Sanchez¹⁵, Jennifer A Schrack¹⁶, Kevin J Sullivan¹⁷, Josef Coresh³, Frank R Lin⁹; ACHIEVE Collaborative Research Group

Affiliations

¹ School of Health and Social Care, Edinburgh Napier University, Edinburgh, UK; Cochlear Center for Hearing and Public Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA. Electronic address: a.goman@napier.ac.uk.
² Cochlear Center for Hearing and Public Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
³ Department of Population Health and Medicine, NYU Grossman School of Medicine, NYU Langone Health, New York, NY, USA.
⁴ Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Department of Otolaryngology-Head and Neck Surgery, Johns Hopkins University, Baltimore, MD, USA.
⁵ School of Health and Social Care, Edinburgh Napier University, Edinburgh, UK.
⁶ Cochlear Center for Hearing and Public Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Department of Otolaryngology-Head and Neck Surgery, Johns Hopkins University, Baltimore, MD, USA.
⁷ Department of Communication Sciences & Disorders, College of Behavioral and Community Sciences, University of South Florida, Tampa, FL, USA.
⁸ Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA.
⁹ Cochlear Center for Hearing and Public Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Department of Otolaryngology-Head and Neck Surgery, Johns Hopkins University, Baltimore, MD, USA.
¹⁰ Department of Epidemiology, School of Public Health, University of Pittsburgh, Pittsburgh, PA, USA.
¹¹ Department of Social Sciences and Health Policy, Wake Forest University School of Medicine, Winston-Salem, NC, USA.
¹² Cochlear Center for Hearing and Public Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
¹³ Division of Epidemiology and Community Health, University of Minnesota School of Public Health, Minneapolis, MN, USA.
¹⁴ Cochlear Center for Hearing and Public Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Department of Population Health and Medicine, NYU Grossman School of Medicine, NYU Langone Health, New York, NY, USA; Department of Otolaryngology-Head and Neck Surgery, NYU Grossman School of Medicine, NYU Langone Health, New York, NY, USA.
¹⁵ Department of Otolaryngology - Head & Neck Surgery, University of South Florida, Tampa, FL, USA.
¹⁶ Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
¹⁷ The MIND Center, University of Mississippi Medical Center, Jackson, MS, USA.

PMID: 40441816
PMCID: PMC12203021
DOI: 10.1016/S2468-2667(25)00088-X

Randomized Controlled Trial

Effects of hearing intervention on falls in older adults: findings from a secondary analysis of the ACHIEVE randomised controlled trial

Adele M Goman et al. Lancet Public Health. 2025 Jun.

. 2025 Jun;10(6):e492-e502.

doi: 10.1016/S2468-2667(25)00088-X.

Authors

Affiliations

¹ School of Health and Social Care, Edinburgh Napier University, Edinburgh, UK; Cochlear Center for Hearing and Public Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA. Electronic address: a.goman@napier.ac.uk.
² Cochlear Center for Hearing and Public Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
³ Department of Population Health and Medicine, NYU Grossman School of Medicine, NYU Langone Health, New York, NY, USA.
⁴ Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Department of Otolaryngology-Head and Neck Surgery, Johns Hopkins University, Baltimore, MD, USA.
⁵ School of Health and Social Care, Edinburgh Napier University, Edinburgh, UK.
⁶ Cochlear Center for Hearing and Public Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Department of Otolaryngology-Head and Neck Surgery, Johns Hopkins University, Baltimore, MD, USA.
⁷ Department of Communication Sciences & Disorders, College of Behavioral and Community Sciences, University of South Florida, Tampa, FL, USA.
⁸ Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA.
⁹ Cochlear Center for Hearing and Public Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Department of Otolaryngology-Head and Neck Surgery, Johns Hopkins University, Baltimore, MD, USA.
¹⁰ Department of Epidemiology, School of Public Health, University of Pittsburgh, Pittsburgh, PA, USA.
¹¹ Department of Social Sciences and Health Policy, Wake Forest University School of Medicine, Winston-Salem, NC, USA.
¹² Cochlear Center for Hearing and Public Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
¹³ Division of Epidemiology and Community Health, University of Minnesota School of Public Health, Minneapolis, MN, USA.
¹⁴ Cochlear Center for Hearing and Public Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Department of Population Health and Medicine, NYU Grossman School of Medicine, NYU Langone Health, New York, NY, USA; Department of Otolaryngology-Head and Neck Surgery, NYU Grossman School of Medicine, NYU Langone Health, New York, NY, USA.
¹⁵ Department of Otolaryngology - Head & Neck Surgery, University of South Florida, Tampa, FL, USA.
¹⁶ Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
¹⁷ The MIND Center, University of Mississippi Medical Center, Jackson, MS, USA.

PMID: 40441816
PMCID: PMC12203021
DOI: 10.1016/S2468-2667(25)00088-X

Abstract

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.

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Conflict of interest statement

Declaration of interests MLA reports consulting fees from GN Resound, the US National Institute on Deafness and Other Communication Disorders (NIDCD), and the US National Institute on Aging (NIA); travel support from the NIDCD and NIA; and receipt of equipment from Sonova. FRL reports being a consultant to Frequency Therapeutics and Apple, and being the Director of a research centre funded in part by a philanthropic gift from Cochlear to the Johns Hopkins Bloomberg School of Public Health. FRL is also a board member of the nonprofit organisation Access HEARS. NSR reports serving on Scientific Advisory Boards of Neosensory, and being a member of the Scientific Advisory Board for Shoebox. VAS reports industry funding related to consulting or research support from Otonomy, Autifony Therapeutics, Boehringer Ingelheim, Frequency Therapeutics, Pipeline Therapeutics, Aerin Medical, Oticon Medical, Helen of Troy, Sonova Holding, and Phonak USA, honoraria from Oticon Medical, Sonova Holding, and Phonak USA related to presentations at sponsored events, and receipt of equipment from Sonova Holding and Phonak USA for educational or research purposes. JAS is a consultant to Edwards Lifesciences, serves on the Scientific Advisory Board of BellSant, has received funding from The Villages related to educational events, and has received funding from McMaster University related to meeting attendance. KMH reports support from Fred Hutchinson Cancer Research Center related to consulting and support from the US National Institutes of Health (NIH) Center for Scientific Review and Hebrew SeniorLife related to attending meetings. ARH reports honoraria from MoCA Cognition and the University of California San Francisco Boost Your Brain Health Study related to presentations. All other authors declare no competing interests.

Figures

**Figure 1:. Covariate-adjusted intention-to-treat analysis of the 3-year rate of falls by randomly assigned treatment in the total cohort and stratified by recruitment source**
Overall means and mean differences were estimated from attrition-weighted linear regression models that examined the mean number of falls over 3 years per participant. The covariate-adjusted model included the number of years of follow-up, the number of falls in the year before the baseline assessment, pair status for randomisation, and baseline age, sex, race, recruitment source, field site, education, diabetes, hypertension, history of stroke, smoking status, 11-item Center for Epidemiologic Studies Depression Scale score, Short Physical Performance Battery balance score, hearing loss severity, Hearing Handicap Inventory for the Elderly Screening Version score, and global cognition factor score. The x-axis shows the adjusted mean difference for the intervention versus control with positive values (favouring the control) to the left and negative values (favouring the intervention) to the right of the vertical line.

**Figure 2:. Covariate-adjusted intention-to-treat analysis of change in fall occurrence by randomly assigned treatment in the total cohort and stratified by recruitment source**
ORs were estimated from attrition-weighted generalised estimating equations of falls occurring after randomisation that were reported at each follow-up year. The model adjusted for the number of falls in the year before the baseline assessment, pair status for randomisation, and baseline age, sex, race, recruitment source, field site, education, diabetes, hypertension, history of stroke, smoking status, 11-item Center for Epidemiologic Studies Depression Scale score, Short Physical Performance Battery balance score, hearing loss severity, Hearing Handicap Inventory for the Elderly Screening Version score, and global cognition factor score. Interactions between randomisation and time, and between time and each covariate, were specified. The x-axis shows the adjusted OR for the intervention versus control with values greater than 1 (favouring the control) to the left and values less than 1 (favouring the intervention) to the right of the vertical line; the x-axis scale is not linear with values above 1 compressed for presentation purposes. OR=odds ratio.

**Figure 3:. Covariate-adjusted intention-to-treat analysis of change in injurious falls by randomly assigned treatment in the total cohort and stratified by recruitment source**
ORs were estimated from attrition-weighted generalised estimating equations of falls occurring after randomisation that were reported at each follow-up year. The model adjusted for the number of falls in the year before the baseline assessment, pair status for randomisation, and baseline age, sex, race, recruitment source, field site, education, diabetes, hypertension, history of stroke, smoking status, 11-item Center for Epidemiologic Studies Depression Scale score, Short Physical Performance Battery balance score, hearing loss severity, Hearing Handicap Inventory for the Elderly Screening Version score, and global cognition factor score. Interactions between randomisation and time, and between time and each covariate, were specified. The x-axis shows the adjusted OR for the intervention versus control with values greater than 1 (favouring the control) to the left and values less than 1 (favouring the intervention) to the right of the vertical line; the x-axis scale is not linear with values above 1 compressed for presentation purposes. OR=odds ratio.

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References

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Effects of hearing intervention on falls in older adults: findings from a secondary analysis of the ACHIEVE randomised controlled trial

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Effects of hearing intervention on falls in older adults: findings from a secondary analysis of the ACHIEVE randomised controlled trial

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