Hearing Loss, Age-RelatedNCT06418321
Early Identification of Age-related Hearing Impairment
An observational study of Hearing Loss, Age-Related, run by Aalto University at 2 sites in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Age-Related
- What is being tested?
- Investigational device, Audiometer and Otomicroscopy
- Type of treatment
- Medical device
- How many people
- 49 participants
- Where
- 2 sitesFinland
- Study dates
- 4 Apr 2024to 12 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers
Who may be able to join
- Must be able to understand Finnish or Swedish
Who cannot join
- Clinical diagnosis of hearing loss
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
Aalto University
Espoo, 02150
HUS Head and Neck Center
Helsinki, 00130
About this study
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.
Read the 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
- Hearing Loss, Age-Related
- Being tested
- Investigational device, Audiometer, Otomicroscopy, REM (Real Ear Measurements)
- Medical subject headings
- Presbycusis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational deviceDevice
The participants' hearing status will be evaluated using the investigational device.
AudiometerOther
Participants' hearing thresholds are tested with an audiogram.
OtomicroscopyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Participant group 1: HUS Helsinki University Hospital | Participants are tested with the investigational device and the gold-standard device. Receives: Device: Investigational device; Other: Audiometer; Device: Otomicroscopy; Other: REM (Real Ear Measurements) | |
| Participant group 2: Aalto University | Participants are tested with the investigational device. Receives: Device: Investigational device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between investigational device and gold-standard device (otomicroscope) findings.
The investigators compare scored views to the outer ear canal and tympanic membrane.
Measured: 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.
Measured: From hearing tests to the comparison (up to six months).
Secondary outcomes (2)
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.
Measured: 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.
Measured: From REM measurements to the analysis of the results (up to six months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start4 Apr 2024
- Primary completion12 Feb 2025
- Study completion12 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, Age-RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalto University
- Sponsor type
- University, hospital or other
- Collaborators
- Business Finland, Helsinki University Central Hospital
- Responsible party
- Sponsor
- Investigators
- Jouni Partanen, Prof., Principal investigator, Aalto University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06418321
- Sponsor's protocol ID
- 535/2024
- Status last verified
- Feb 2025
- First submitted
- 15 Apr 2024
- Last updated
- 20 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Identification of Age-related Hearing Impairment
- ClinicalTrials.gov ID
- NCT06418321
- Acronym / sponsor ID
- 535/2024
- Conditions
- Hearing Loss, Age-Related
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Aalto UniversityUniversity, hospital or other
- Collaborators
- Business Finland, Helsinki University Central Hospital
- Study start
- 4 Apr 2024 (actual)
- Primary completion
- 12 Feb 2025 (actual)
- Study completion
- 12 Feb 2025 (actual)
- First posted
- 17 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participant group 1: HUS Helsinki University Hospital | – | Device: Investigational device, Other: Audiometer, Device: Otomicroscopy, Other: REM (Real Ear Measurements)Participants are tested with the investigational device and the gold-standard device. |
| Participant group 2: Aalto University | – | Device: Investigational deviceParticipants are tested with the investigational device. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers
Key inclusion criteria (1 listed)
- Must be able to understand Finnish or Swedish
Key exclusion criteria (1 listed)
- Clinical diagnosis of hearing loss
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigational deviceThe participants' hearing status will be evaluated using the investigational device. | Device | Participant group 1: HUS Helsinki University Hospital, Participant group 2: Aalto University |
| AudiometerParticipants' hearing thresholds are tested with an audiogram. | Other | Participant group 1: HUS Helsinki University Hospital |
| OtomicroscopyThe status of the participants' ear canals and tympanic membranes are checked. | Device | Participant group 1: HUS Helsinki University Hospital |
| REM (Real Ear Measurements)The acoustic properties of the participants' ears will be measured during the interventions. | Other | Participant group 1: HUS Helsinki University Hospital |
Primary outcome
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.
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.
2 secondary outcomes
Participant group 2: The usability of the investigational device.
Time frame: From study appointment to the analysis of the results (up to six months).
Participant group 1: REM measurements.
Time frame: From REM measurements to the analysis of the results (up to six months).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jouni Partanen, Prof. principal investigator
Aalto University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss, Age-Related, run by Aalto University at 2 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.