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
- Journal
- BMJ open (Q1)
- Published
- 21 July 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Laura Ihalainen, Mariagnese Barbera, Timo Törmäkangas, Petteri Hyvärinen, Tytti Willberg, Pia Linder, et al.
- PMID
- 42481198
- DOI
- 10.1136/bmjopen-2026-122681
Why clinicians should know about it
- Picked for Otorhinolaryngology (top studies of the week, 11 October 2026): Data‑driven hearing rehab vs standard care in older adults
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.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.