Hearing diagnostics using Sound Ear Check in young children
Sound Ear Check (SEC) in Hearing Diagnostics in Young Children Undergoing Tympanostomy Tube Insertion
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 |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 3 Years to 10 Years |
| Sex | All |
| Sponsor | Turku University Hospital Government |
| Locations | 1 site (Turku) |
| Trial ID | NCT05535634 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with prior sensorineural hearing loss, developmental disorders, or previous ear surgeries (except tympanostomy insertion) may not benefit from this study.
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 performed: While the SEC approach is innovative, similar automated hearing tests have shown promise in other studies, indicating potential for success.
Eligibility criteria
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 this trial is running
Turku
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.