Early Identification of Age-related Hearing Impairment
1 other identifier
observational
49
1 country
2
Brief Summary
The need for future hearing rehabilitation is enormous. World Health Organization (WHO 2021) has estimated that by 2050, 2.5 billion people will have some degree of hearing loss, and 1/4 of them will require hearing rehabilitation. Currently, healthcare systems and processes are already overwhelmed and not adequately equipped to screen and diagnose this rapidly growing population suffering from hearing impairment. This study aims to investigate if the diagnostics of age-related hearing loss can be accelerated by involving patients in the hearing assessment process.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2024
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 4, 2024
CompletedFirst Submitted
Initial submission to the registry
April 15, 2024
CompletedFirst Posted
Study publicly available on registry
May 17, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 12, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 12, 2025
CompletedFebruary 20, 2025
February 1, 2025
10 months
April 15, 2024
February 18, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Comparison between investigational device and gold-standard device (otomicroscope) findings.
The investigators compare scored views to the outer ear canal and tympanic membrane.
From digital otoscopy to the interpretation of pictures (up to six months).
Comparison between the automated hearing screening self-test result and the gold-standard hearing test result performed with clinical Audiometer by an Audiologist.
The investigators compare pure tone averages.
From hearing tests to the comparison (up to six months).
Secondary Outcomes (2)
Participant group 2: The usability of the investigational device.
From study appointment to the analysis of the results (up to six months).
Participant group 1: REM measurements.
From REM measurements to the analysis of the results (up to six months).
Study Arms (2)
Participant group 1: HUS Helsinki University Hospital
Participants are tested with the investigational device and the gold-standard device.
Participant group 2: Aalto University
Participants are tested with the investigational device.
Interventions
The participants' hearing status will be evaluated using the investigational device.
Participants' hearing thresholds are tested with an audiogram.
The status of the participants' ear canals and tympanic membranes are checked.
The acoustic properties of the participants' ears will be measured during the interventions.
Eligibility Criteria
Healthy volunteers
You may qualify if:
- Must be able to understand Finnish or Swedish
You may not qualify if:
- Clinical diagnosis of hearing loss
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aalto Universitylead
- Business Finlandcollaborator
- Helsinki University Central Hospitalcollaborator
Study Sites (2)
Aalto University
Espoo, 02150, Finland
HUS Head and Neck Center
Helsinki, 00130, Finland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jouni Partanen, Prof.
Aalto University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2024
First Posted
May 17, 2024
Study Start
April 4, 2024
Primary Completion
February 12, 2025
Study Completion
February 12, 2025
Last Updated
February 20, 2025
Record last verified: 2025-02