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NCT Number: NCT06418321

Early Identification of Age-related Hearing Impairment

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.

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Key information

Conditions

Hearing Loss, Age-Related Ear Diseases Hearing Disorders Hearing Loss Hearing Loss, Sensorineural Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Presbycusis Sensation Disorders Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aalto University, Espoo, Finland

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must be able to understand Finnish or Swedish

Exclusion criteria

  • Clinical diagnosis of hearing loss

Treatment and study plan

Investigational device

Device

The participants' hearing status will be evaluated using the investigational device.

Audiometer

Other

Participants' hearing thresholds are tested with an audiogram.

Otomicroscopy

Device

The status of the participants' ear canals and tympanic membranes are checked.

REM (Real Ear Measurements)

Other

The acoustic properties of the participants' ears will be measured during the interventions.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Aalto University

Other

Collaborators

  • Business Finland
  • Helsinki University Central Hospital

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 17, 2024
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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