The Phonak EduLink-System in Students With Specific Performance Deficits in Speech-in-Noise Intelligibility

Study Overview
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Brief Summary
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In the management and remediation of students with specific performance deficits in speech-in-noise intelligibility, most often, a triad approach for treatment is used, which includes direct therapy, compensatory strategies, and environmental modifications. The purpose of the study is to determine whether a new hearing aid, the Phonak EduLink-FM System, can improve specific performance deficits in speech-in-noise intelligibility. Participants will complete a test battery related to auditory processing, as well as some psychological tests and questionnaires. One group of participants with specific performance deficits in speech-in-noise intelligibility will receive the hearing aid for use in school; a second group will not. The effect of this treatment on auditory performance, school performance and satisfaction, attention and verbal learning and memory, self concept, behavior and listening effort following 26 weeks of hearing aid use will be compared across the groups.

Official Title
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The Phonak EduLink-System in Students With Specific Performance Deficits in Speech-in-Noise Intelligibility

Conditions
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Auditory Processing Disorder

Intervention / Treatment
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* Device: hearing aid, Phonak EduLink-FM System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of specific performance deficits in speech-in-noise intelligibility based on two or more standardized tests of auditory processing in noise including retests. Students in the 1st to 4th class of primary school Exclusion Criteria: Hearing loss, defined as: Air conduction pure tone thresholds (250-8000 Hz) exceeding 20 dBHL Air-bone gaps, even in the presence of normal sensitivity, exceeding 10 dBHL Abnormal tympanogram History or diagnosis of behavioral and/or emotional disorders meeting ICD-GM-criteria (including attention deficit/hyperactivity disorders (AD-/HD) Non-German speaking Cognitively impaired children (IQ < 85) Children currently using psychoactive medication Students with special education

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: hearing aid, Phonak EduLink-FM System|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| auditory performance |  | following 26 weeks hearing aid use | 
| school performance and satisfaction |  | following 26 weeks hearing aid use | 
| attention |  | following 26 weeks hearing aid use | 
| verbal learning and memory |  | following 26 weeks hearing aid use | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| self concept |  | following 26 weeks hearing aid use | 
| behavior |  | following 26 weeks hearing aid use | 
| listening effort |  | following 26 weeks hearing aid use | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Auditory Processing Disorder, speech-in-noise intelligibility