Healthy heaAring for Healthy Ageing: Data-driven Hearing Rehabilitation Intervention to Promote Healthy Hearing
Key facts
- Who runs it
- Kuopio University Hospital
- Where
- Finland1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Active, not recruiting
- People taking part
- 200 people, planned
- Started
- 1 Oct 2024
- Expected to end
- 29 Feb 2028
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Individualised data-driven hearing rehabilitation
- Standard care hearing rehabilitation
- Record updated
- 4 March 2026
Who can take part
- Age
- 65 years to 84 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- Mild to moderately severe sensorineural HI (PTA (0,5-4kHz) between 20-64 dB (HL), as per Global Burden of Disease Expert Group on Hearing loss criteria)
- Community-dwelling, i.e. living at home / not living in a care home or nursing home
- Proficiency in Finnish language
- First-time hearing aid user
Who cannot take part
- Previously diagnosed dementia, or current use of cholinesterase inhibitors and/or memantine. If there is a current ongoing diagnostic process for suspected dementia, the decision on eligibility will be made by an experienced study physician based on medical records and clinical judgement
- Any health conditions severely impairing vision, mobility, communication, and/or ability to participate in study visits and complete study assessments, as judged by the study nurse and/or physician
- Conductive hearing loss (air-bone gap more than 20 dB HL in two consecutive frequencies)
- Difference between hearing levels of the ears is more than 15dB (HL) in three consecutive frequencies
- Hearing aid contraindication
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
The goal of the HAHA trial is to prove that the treatment of HI and prevention of HI-related cognitive decline are most likely to be effective if HI is approached as a broader neurodegenerative entity with multifaceted manifestations currently unaddressed in clinical practice and managed using a novel individualised data-driven protocol for early hearing rehabilitation. The main hypothesis is that, compared with standard care, the data-driven rehabilitation will likely have broader benefits manifested in three key areas: hearing, cognition, and quality of life and psychosocial outcomes.
Read full original descriptionShow less
Participants will be randomized 1:1 to either intervention (individualised data-driven hearing rehabilitation) or control group (standard care hearing rehabilitation). The primary objective of this study is to investigate the effect of an optimized data-driven hearing rehabilitation protocol versus standard care protocol on change in speech perception in noise (SPIN) in older adults with mild to moderately severe sensorineural HI and without dementia.
The 2 groups in the trial
- Individualised data-driven hearing rehabilitationExisting treatment, for comparison
Participants in the intervention group will receive data-driven, regularly controlled hearing aid rehabilitation that is not part of the standard care protocol.
- Standard care hearing rehabilitationExisting treatment, for comparison
The participants in the control group will receive the standard care HA rehabilitation currently conducted at the KUH Hearing Center.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Healthy Hearing for Healthy Ageing: a Proof-of-concept Randomized Controlled Trial of Data-driven Hearing Rehabilitation Versus Standard Care in Older Adults With Hearing Impairment.
- Publications
- Record updated
- 4 March 2026