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Early Identification of Age-related Hearing Impairment

A

Aalto University

Status

Completed

Conditions

Hearing Loss, Age-Related

Treatments

Device: Investigational device
Device: Otomicroscopy
Other: Audiometer
Other: REM (Real Ear Measurements)

Study type

Observational

Funder types

Other

Identifiers

NCT06418321
535/2024

Details and patient eligibility

About

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.

Full 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.

Enrollment

49 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

• Must be able to understand Finnish or Swedish

Exclusion criteria

• Clinical diagnosis of hearing loss

Trial design

49 participants in 2 patient groups

Participant group 1: HUS Helsinki University Hospital
Description:
Participants are tested with the investigational device and the gold-standard device.
Treatment:
Other: REM (Real Ear Measurements)
Other: Audiometer
Device: Otomicroscopy
Device: Investigational device
Participant group 2: Aalto University
Description:
Participants are tested with the investigational device.
Treatment:
Device: Investigational device

Trial contacts and locations

2

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Central trial contact

Tanja Tervonen

Data sourced from clinicaltrials.gov

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