Early Identification of Age-related Hearing Impairment

Hearing Loss, Age-Related Clinical Trial

Official title:

Early Identification of Age-related Hearing Impairment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06418321
• Other study ID #: 535/2024
• Status: Recruiting
• Start date: April 4, 2024
• Est. completion date: May 1, 2026

Study information

• Verified date: May 2024
• Source: Aalto University
• Contact: Tanja Tervonen
• Phone: +358400240800
• Email: tanja.tervonen[@]aalto.fi
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: May 1, 2026
• Est. primary completion date: May 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Must be able to understand Finnish or Swedish

Exclusion Criteria:

• Clinical diagnosis of hearing loss

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Age-Related
• Presbycusis

Intervention

Device:
• Investigational device
The participants' hearing status will be evaluated using the investigational device.

Other:
• Audiometer
Participants' hearing thresholds are tested with an audiogram.

Device:
• Otomicroscopy
The status of the participants' ear canals and tympanic membranes are checked.

Other:
• REM (Real Ear Measurements)
The acoustic properties of the participants' ears will be measured during the interventions.

Locations

Country	Name	City	State
Finland	Aalto University	Espoo
Finland	HUS Head and Neck Center	Helsinki

Sponsors (3)

Lead Sponsor	Collaborator
Aalto University	Business Finland, Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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	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.	From study appointment to the analysis of the results (up to six months).
Secondary	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.	From REM measurements to the analysis of the results (up to six months).