Trials / Completed
CompletedNCT06418321
Early Identification of Age-related Hearing Impairment
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 49 (actual)
- Sponsor
- Aalto University · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2024-04-04
- Primary completion
- 2025-02-12
- Completion
- 2025-02-12
- First posted
- 2024-05-17
- Last updated
- 2025-02-20
Locations
2 sites across 1 country: Finland
Source: ClinicalTrials.gov record NCT06418321. Inclusion in this directory is not an endorsement.