Proof-of-concept randomised controlled trial of data-driven hearing rehabilitation versus standard care in older adults with hearing loss: the healthy hearing for healthy ageing protocol.

Laura Ihalainen, Mariagnese Barbera, Timo Törmäkangas, Petteri Hyvärinen, Tytti Willberg, Pia Linder, Alina Solomon, Aarno Dietz

Journal: BMJ open 2026;16(7):e122681

PMID: 42481198

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Abstract

INTRODUCTION

Hearing aids (HAs) can alleviate hearing loss; however, HA rehabilitation is frequently hampered by delayed diagnosis, suboptimal fitting and lack of systematic follow-up. Although the association between hearing loss and cognitive decline has been identified, evidence from randomised controlled trials remains limited. Addressing these gaps is essential for reducing hearing loss-related experiences and evaluating whether effective HA use could reduce the risk of cognitive decline.

METHODS AND ANALYSIS

The healthy hearing for healthy ageing study is a proof-of-concept, single-site, two-arm parallel-group 12-month randomised controlled trial with a 12-month extended follow-up. Up to two hundred participants with hearing loss and without cognitive decline referred for an initial HA rehabilitation are recruited and randomised 1:1 to either data-driven hearing rehabilitation or standard care. The primary outcome is the change in two speech perception in noise tests validated for the Finnish language: the Finnish matrix sentence test and the digits-in-noise test. The secondary outcomes are patient-reported outcomes (eg, Hearing in Real-Life Environment and Speech, Spatial and Quality questionnaires), quality of life (eg, 15D-questionnaire), cognitive (eg, Consortium to Establish a Registry for Alzheimer's Disease test) and psychosocial measures. Exploratory outcomes include event-related responses, cortical auditory evoked potentials, structural brain imaging and vision-related measures.

ETHICS AND DISSEMINATION

Ethical approval has been obtained from the Regional Medical Research Ethics Committee of the well-being Services County of North Savo (approval no. 697/2023). Findings from this study will be disseminated through peer-reviewed publications, conference presentations and relevant clinical and patient communities.

TRIAL REGISTRATION NUMBER

NCT06495268.

Address: Department of Otorhinolaryngology, Kuopio University Hospital, Kuopio, Finland [email protected].; Institute of Clinical Medicine, University of Eastern Finland, Kuopio, Finland.; Institute of Clinical Medicine, University of Eastern Finland, Kuopio, Finland.; The Ageing Epidemiology Research Unit, School of Public Health, Imperial College London, Charing Cross Hospital, London, UK.; Gerontology Research Center, Faculty of Sport and Health Sciences, Jyvaskylan Yliopisto, Jyvaskyla, Finland.; Department of Otorhinolaryngology, Kuopio University Hospital, Kuopio, Finland.; Department of Otorhinolaryngology, Turku University Central Hospital, Turku, Southwest Finland, Finland.; Department of Otorhinolaryngology, Kuopio University Hospital, Kuopio, Finland.; Institute of Clinical Medicine, University of Eastern Finland, Kuopio, Finland.; Institute of Clinical Medicine, University of Eastern Finland, Kuopio, Finland.; The Ageing Epidemiology Research Unit, School of Public Health, Imperial College London, Charing Cross Hospital, London, UK.; Division of Clinical Geriatrics, Center for Alzheimer Research, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.

DOI: 10.1136/bmjopen-2026-122681

MeSH Terms: Humans, Hearing Aids, Aged, Hearing Loss, Quality of Life, Male, Proof of Concept Study, Female, Speech Perception, Healthy Aging, Correction of Hearing Impairment