Hearing diagnostics using Sound Ear Check in young children
Official title: Sound Ear Check (SEC) in Hearing Diagnostics in Young Children Undergoing Tympanostomy Tube Insertion
Run by Turku University Hospital · NCT05535634 · Data updated 2026-11-12
This study is testing a new tablet-based hearing test called Sound Ear Check to see if it can help find hearing problems in healthy children aged 3 to 10 who are getting ear tubes.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 3 Years to 10 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Turku University Hospital Government |
| Locations | 1 site (Turku) |
| Status | Recruiting |
| Started | August 31, 2022 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | September 10, 2022 |
| Trial ID | NCT05535634 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are Finnish-speaking children aged 3 to 10 years who are otherwise healthy and scheduled for tympanostomy tube placement.
✕Probably not a fit
Patients with prior sensorineural hearing loss, developmental disorders, or previous ear surgeries (except tympanostomy insertion) may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study evaluates the effectiveness of the Sound Ear Check (SEC), an automated tablet-based self-test, in diagnosing hearing issues among children aged 3 to 10 years who are otherwise healthy and referred for tympanostomy tube placement. The SEC test will be administered before surgery and again one month post-operation to assess changes in hearing ability. The study will also collect medical history and ear-related quality of life data through questionnaires, comparing SEC results with middle ear findings and tympanometric assessments.
Why it matters
Potential benefit: If successful, this study could improve early detection and management of hearing loss in young children, leading to better health outcomes.
How similar studies have gone: While the SEC approach is innovative, similar automated hearing tests have shown promise in other studies, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Finnish speaking (child and parent) Exclusion Criteria: * Prior sensorineural hearing loss * developmental disorder * Prior ear surgery (except tympanostomy insertion)
Where it's running
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Turku University Hospital, Department of Otorhinolaryngology and head and neck surgery
Turku, Finland Recruiting
Study contacts
- Principal investigator: Lotta Haavisto, PhD — Hospital District of Southwest Finland
- Study coordinator: Lotta Haavisto, PhD
- Email: lotta.haavisto@tyks.fi
- Phone: +358 23130000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.