Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
49 participants
OBSERVATIONAL
2024-04-04
2025-02-12
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Participant group 1: HUS Helsinki University Hospital
Participants are tested with the investigational device and the gold-standard device.
Investigational device
The participants' hearing status will be evaluated using the investigational device.
Audiometer
Participants' hearing thresholds are tested with an audiogram.
Otomicroscopy
The status of the participants' ear canals and tympanic membranes are checked.
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.
Investigational device
The participants' hearing status will be evaluated using the investigational device.
Interventions
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Investigational device
The participants' hearing status will be evaluated using the investigational device.
Audiometer
Participants' hearing thresholds are tested with an audiogram.
Otomicroscopy
The status of the participants' ear canals and tympanic membranes are checked.
REM (Real Ear Measurements)
The acoustic properties of the participants' ears will be measured during the interventions.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
70 Years
ALL
Yes
Sponsors
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Business Finland
OTHER
Helsinki University Central Hospital
OTHER
Aalto University
OTHER
Responsible Party
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Principal Investigators
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Jouni Partanen, Prof.
Role: PRINCIPAL_INVESTIGATOR
Aalto University
Locations
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Aalto University
Espoo, , Finland
HUS Head and Neck Center
Helsinki, , Finland
Countries
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Other Identifiers
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535/2024
Identifier Type: -
Identifier Source: org_study_id
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