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

Not Applicable

• Conditions: Auditory Processing Disorder

• Registration Number: NCT00167128
• Lead Sponsor: University Hospital Muenster

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-14
• Status Verified: 2006-05
• Last Update Submitted: 2007-08-14
• Last Update Posted: 2007-08-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
self concept	following 26 weeks hearing aid use
behavior	following 26 weeks hearing aid use
listening effort	following 26 weeks hearing aid use

Trial Locations

Locations (2)

Department of Phoniatrics and Pediatric Audiology, University Hospital Münster; 🇩🇪 Münster, Germany

Phonak AG; 🇨🇭 Stäfa, Switzerland