Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2025-12-24 @ 5:45 PM
NCT ID:
NCT06495268
Eligibility Criteria:
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Maximum Age:
84 Years
Study:
NCT06495268
Study Brief:
Protocol Section:
NCT06495268