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| Name | Class |
|---|---|
| Business Finland | OTHER |
| Helsinki University Central Hospital | OTHER |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participant group 1: HUS Helsinki University Hospital | Participants are tested with the investigational device and the gold-standard device. |
| |
| Participant group 2: Aalto University | Participants are tested with the investigational device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational device | Device | The participants' hearing status will be evaluated using the investigational device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
• Must be able to understand Finnish or Swedish
Exclusion Criteria:
• Clinical diagnosis of hearing loss
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Healthy volunteers
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| Name | Affiliation | Role |
|---|---|---|
| Jouni Partanen, Prof. | Aalto University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalto University | Espoo | 02150 | Finland | |||
| HUS Head and Neck Center |
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| ID | Term |
|---|---|
| D011304 | Presbycusis |
| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
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| ID | Term |
|---|---|
| D012895 | Sleep, REM |
| ID | Term |
|---|---|
| D012894 | Sleep Stages |
| D012890 | Sleep |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Audiometer | Other | Participants' hearing thresholds are tested with an audiogram. |
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| 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. |
|
| From study appointment to the analysis of the results (up to six months). |
| 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). |
| Helsinki |
| 00130 |
| Finland |
| D010038 |
| Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |