An observational study in Hearing Loss, Age-Related, sponsored by Aalto University. Completed at 2 sites in Finland. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-20.
Sponsored by Aalto University · Observational
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.
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:
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.
66 studies on the registry are indexed under Presbycusis; 21 are open to participants now.
This study's enrollment of 49 is below the median of 123 across 20 observational studies indexed under Presbycusis.
Browse Presbycusis studies →Aalto University is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
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Healthy volunteers
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants are tested with the investigational device and the gold-standard device.
Device: Investigational device · Other: Audiometer · Device: Otomicroscopy · Other: REM (Real Ear Measurements)
Participants are tested with the investigational device.
Device: Investigational device
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.
Comparison between investigational device and gold-standard device (otomicroscope) findings.
The investigators compare scored views to the outer ear canal and tympanic membrane.
Time frame: 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.
Time frame: From hearing tests to the comparison (up to six months).
Participant group 2: The usability of the investigational device.
The usability of the investigational device will be assessed using a usability testing protocol. It includes subjective feedback from participants through interviews, questionnaires, and observation of device use. The usability will be assessed using the AttrakDiff method, a standardized questionnaire designed to measure the user's perception of a product's attractiveness, pragmatism, and overall appeal. This method provides insights into both the pragmatic and hedonic aspects of usability. AttrakDiff consists of multiple items scored on a semantic differential scale that consists of seven-step items whose poles are opposite adjectives (e.g. "confusing - clear", "unusual - ordinary", "good - bad"). Each set of adjective items is ordered into a scale of intensity. Usability testing will be conducted iteratively with the first group of participants (N=20), followed by modifications based on feedback. This iterative process will continue until no negative feedback is received.
Time frame: From study appointment to the analysis of the results (up to six months).
Participant group 1: REM measurements.
If there is a difference between the automated hearing screening self-test result and the gold-standard hearing test result performed with clinical Audiometer, the investigators will look for the REM results if there is an explanation for the difference at the individual level.
Time frame: From REM measurements to the analysis of the results (up to six months).
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Aalto University