Early Identification of Age-related Hearing Impairment

February 18, 2025 updated by: Aalto University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

49

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Espoo, Finland, 02150
        • Aalto University
      • Helsinki, Finland, 00130
        • HUS Head and Neck Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Healthy volunteers

Description

Inclusion Criteria:

• Must be able to understand Finnish or Swedish

Exclusion Criteria:

• Clinical diagnosis of hearing loss

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participant group 1: HUS Helsinki University Hospital
Participants are tested with the investigational device and the gold-standard device.
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.
Participant group 2: Aalto University
Participants are tested with the investigational device.
Device: Investigational device
The participants' hearing status will be evaluated using the investigational device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
Time Frame: From hearing tests to the comparison (up to six months).
The investigators compare pure tone averages.
From hearing tests to the comparison (up to six months).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant group 2: The usability of the investigational device.
Time Frame: From study appointment to the analysis of the results (up to six months).

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).
Participant group 1: REM measurements.
Time Frame: From REM measurements to the analysis of the results (up to six months).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aalto University

Collaborators

Helsinki University Central Hospital
Business Finland

Investigators

  • Principal Investigator: Jouni Partanen, Prof., Aalto University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2024

Primary Completion (Actual)

February 12, 2025

Study Completion (Actual)

February 12, 2025

Study Registration Dates

First Submitted

April 15, 2024

First Submitted That Met QC Criteria

May 13, 2024

First Posted (Actual)

May 17, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 18, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 535/2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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