Early Identification of Age-related Hearing Impairment
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hearing Loss, Age-Related
- Sponsor
- Aalto University
- Enrollment
- 49
- Locations
- 2
- Primary Endpoint
- Comparison between the automated hearing screening self-test result and the gold-standard hearing test result performed with clinical Audiometer by an Audiologist.
- Status
- Completed
- Last Updated
- last year
Overview
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.
Detailed Description
The investigational device used in the study is part of the Otoscreen hearing screening system that is developed by Aalto University. The investigational device consists of the following parts: * Digital otoscope * User interface control unit. The investigational device is designed to record high-quality images and videos of the eardrum and ear canal and guide users through a hearing screening test while collecting data from questionnaires, digital otoscopy, and audiometry. The investigational device is used together with a CE-marked audiometer that is intended for hearing screening testing.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Must be able to understand Finnish or Swedish
Exclusion Criteria
- •Clinical diagnosis of hearing loss
Outcomes
Primary Outcomes
Comparison between the automated hearing screening self-test result and the gold-standard hearing test result performed with clinical Audiometer by an Audiologist.
Time Frame: From hearing tests to the comparison (up to six months).
The investigators compare pure tone averages.
Comparison between investigational device and gold-standard device (otomicroscope) findings.
Time Frame: From digital otoscopy to the interpretation of pictures (up to six months).
The investigators compare scored views to the outer ear canal and tympanic membrane.
Secondary Outcomes
- Participant group 1: REM measurements.(From REM measurements to the analysis of the results (up to six months).)
- Participant group 2: The usability of the investigational device.(From study appointment to the analysis of the results (up to six months).)