Hearing Loss Clinical Trial
Official title:
Evaluation of Performance and Usability of N6 in the Paediatric Population
The purpose of this study is to evaluate the performance and usability of the N6 system in children with the N5 system.
This study will evaluate the user benefits of the N6 system in the paediatric population
currently equipped with N5. The performance and usability of both systems will be evaluated
and compared. The performance of the N6 is expected to be at least equivalent to the N5.
Outcome measures:
- City University of New York (CUNY) Sentence Test in quiet and noise
- Consonant-Nucleus-Consonant (CNC) words in quiet
- in-house designed Usability questionnaires of the N6 system (information to be used
internally)
- PEACH, TEACH and SELF questionnaires - developed by Ching & Hill (2007). PEACH - The
Parents' Evaluation of Aural/oral performance of Children TEACH - The Teachers'
Evaluation of Aural/oral performance of Children for teachers SELF - The Child's Self
evaluation of aural/oral performance.
Speech perception tests will be administered at baseline, then again three times, two weeks
apart with the N6 processor - i.e. week 0, week 2, week 4 & week 6. Total time: 2 months.
Questionnaires will also be given at the same time points, to get baseline information, as
well as N6 information
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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