Clinical trial Recruiting at 1 site Observational Ages 3 to 10

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 typeObservational
Ages3 Years to 10 Years
SexAll
Enrollment100 (estimated)
SponsorTurku University Hospital
Government
Locations1 site (Turku)
StatusRecruiting
StartedAugust 31, 2022
Main results expectedDecember 31, 2028
Study endsDecember 31, 2028
Registry record updatedSeptember 10, 2022
Trial IDNCT05535634 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

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.