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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06418321
Study type Observational
Source Aalto University
Contact Tanja Tervonen
Phone +358400240800
Email tanja.tervonen@aalto.fi
Status Recruiting
Phase
Start date April 4, 2024
Completion date May 1, 2026

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