Sound Ear Check (SEC) in Hearing Diagnostics in Young Children

Study Overview
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Brief Summary
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Study Sound Ear Check (SEC) hearing test among 3-10 years old otherwise healthy children referred to tympanostomy tube placement. SEC test prior surgery (with middle ear fluid) and at 1 month control visit (dry middle ear with ventilation tube). Otitis media 6 questionnaire prior surgery and at the 1 month control visit.

Detailed Description
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Sound Ear Check (SEC) is an automated tablet-based self-test that uses common nonspeech sounds (ecological sounds) that are accompanied by pictures that are easily recognizable even for younger children. Before TTI operation, each participant will be tested with SEC using normal (dichotic) sounds and antiphasic sounds. Results will be compared to middle ear findings and the test will be repeated one month after the operation when the middle ears are checked to be dry (with a ventilation tube). At the time of the myringotomy during TTI operation, possible middle ear fluid will be classified as serous (transparent, clear), mucous (thick) or purulent (consisting of pus). A tympanometry will be performed within the same visit as the SEC measurement before the TTI operation. At the time of tympanometric examination, each participant will be classified as cooperative (sittings still, not crying, not resisting) or non-cooperative. Tympanometric findings will be classified after the Jerger classification. SEC and tympanometric testing is designed to be performed at the same visit as TTI operation as patients will be waiting for the operation at the ward. Medical history of the study patients will be collected from the hospital patient records and through interview and questionnaires to the subjects. Ear related quality of life questionnaire (OM-6) will be performed at the beginning of the study and the one month control visit. Questionnaires are collected using web-based REDCap -software (Research Electronic Data Capture).

Official Title
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Sound Ear Check (SEC) in Hearing Diagnostics in Young Children Undergoing Tympanostomy Tube Insertion

Conditions
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Tympanostomy, Hearing Loss, Otitis Media With Effusion

Intervention / Treatment
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* Diagnostic Test: Sound Ear Check


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Finnish speaking (child and parent) Exclusion Criteria: Prior sensorineural hearing loss developmental disorder Prior ear surgery (except tympanostomy insertion)

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children referred for tympanostomy tube insertion<br>Study Sound Ear Check (SEC) hearing test among 3-10 years old otherwise healthy children referred to tympanostomy tube placement. SEC test prior surgery (with middle ear fluid) and at 1 month control visit (dry middle ear with ventilation tube). Otitis media 6 questionnaire prior surgery and at the 1 month control visit. | Diagnostic Test: Sound Ear Check<br>* Hearing test, measurement of the input impedance of the middle-ear transmission system<br>* Other names: Tympanometry;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SNR | Signal to noise ratio | 1-2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Otitis media 6 questionnaire | questionnaire | 1-2 months |