MyPhonak App Junior Pediatric Usability and Benefit Investigation

Study Overview
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Brief Summary
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ESolutions functions for children and young people with the myPhonak app is a prospective study to investigate whether the myPhonak app can improve speech understanding in children with hearing aids. The study is linked to randomized patient and test allocation carried out.

Official Title
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ESolutions Functions for Children and Young People With the myPhonak App

Conditions
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Hearing Loss

Intervention / Treatment
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* Device: MyPhonak Junior App


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children and adolescents between the ages of 7 and 17 years old. With normal middle ear characteristics With a hearing impairment in the mild to severe range With adequate speech development Exclusion Criteria: Unreliability and lack of cooperation exists, An effusion in the middle ear or local inflammation in the ear canal or middle ear with/without a running ear, Mental limitations, If the patient is unable to operate a smartphone, Other objections to study participation in the opinion of the study director exist.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 17 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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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Study Group<br>It is a prospective study to investigate whether the MyPhonak Junior app can improve speech understanding in children with hearing aids, by evaluating the use of the volume, noise reduction and directional microphone using the MyPhonak Junior App.. The study is linked to randomized patient and test allocation carried out. Introduction to the MyPhonak Junior app. There are measurements of speech understanding of sentences Carried out in background noise with the Oldenburg sentence test (OLSA). The language test is hard of hearing children and adolescents known from routine clinical practice. Various everyday situations / noise scenarios are played out. Questionnaire (E-HAK, also known from routine) and interview of the children regarding the use of the app in everyday life. | Device: MyPhonak Junior App<br>* The primary objective is to evaluate the effects on speech intelligibility of resulting from the changes that children and adolescents (aged 7 to 17 years) make to the volume control, directionality and noise reduction of the hearing of the hearing aids using the myPhonak app. First, in a controlled laboratory environment under the guidance of the principal investigator is tested. Then, using sound scenarios, the child is allowed to try out two programs with the aid of using the app and the volume control, respectively. After this, the speech comprehension of sentences in noise is tested in the individual programs using the Oldenburg Sentence Test (OLSA).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in OLSA score after subjects adjust hearing aid with MyPhonak Junior App | At the first face-to-face the subject will be trained on the app, and complete the OLSA. After 2 week home trial, the OLSA will be re-administered to see if the adjustments the subjects made using the MyPhonak Junior app impacted speech intelligibility, which would be shown by the OLSA score at the second face-to-face visit. | 4 weeks for each subject (2 face-to-face visits + 2 weeks home trial), 12 months in total for study to be completed |