NCT01800929

Evaluation of Performance and Usability of N6 in the Paediatric Population

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Cochlear, Asia Pacific · Academic / Other
• Sex: All
• Age: 5 Years – 14 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the performance and usability of the N6 system in children with the N5 system.

Detailed description

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

Conditions

• Transplants and Implants
• Hearing Loss

Interventions

Type	Name	Description
DEVICE	N6	Children with N5 will be upgraded to the N6 for a period of up to 2 months to evaluate.

Timeline

• Start date: 2012-11-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2013-02-28
• Last updated: 2013-03-01

Locations

4 sites across 2 countries: Australia, New Zealand