Hearing Loss, Transplants and Implants
Conditions
Brief 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
Interventions
DEVICEN6
Children with N5 will be upgraded to the N6 for a period of up to 2 months to evaluate.
Sponsors
The HEARing Co-operative Research Centre, Melbourne
Melbourne Cochlear Implant Clinic, Melbourne
The Shepherd Centre, Sydney
Hear and Say Centre
The Hearing House, Auckland
Cochlear, Asia Pacific
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 14 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 5-14 years, currently using N5 * Minimum speech perception ability in noise of 30% at +10 decibels (dB) signal-to-noise ratio (SNR). * Minimum of 2 years cochlear implant (CI) experience, including at least 6 months experience with their current processor * Excellent verbal reporters * Excellent record of attending clinical appointments. * Attend a regular school, * English 1st language. * Excellent record of compliance with habilitation tasks.
Exclusion criteria
* Cognitive impairment, or other significant impairment that would impact on their ability to undertake task requirements * Inability to attend study appointments.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Group usability performance data for N6 versus N5 | Nov 2012-June 2013 | The investigational sound processor, remote assistant and fitting software will be compared to the existing implant system on measures of speech perception and usability in a take-home study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| speech recognition scores in quiet and noise between the two processors | Nov 2012-June 2013 | The CUNY sentences and CNC word lists will be administered in quiet and noise. |
| Useability questionnaire on the different sound processing features | Nov 2012-June 2013 | An in house questionnaire has been developed where the parent is asked to rank various features of the device, and its usability on a 5-point Likert Scale |
| Subjective feedback on performance as well as patient preference between the 2 processors | Nov 2012-June 2013 | The PEACH, TEACH and SELF (Ching & Hill, 2007) will be used to collect this information from the parent, teacher and child. These questionnaires have been used in many previous studies. In addition, any verbal feedback provided by recipients will be noted on CRFs. |
| Evaluate the usability of the two systems in a group of children, their carers and their teachers | Nov 2012-June 2013 | The information from the above questionnaires will be used to collectively compare the usability of the child's current processor and the N6 processor. |
| Clinical recommendations for fitting paediatric recipients with the new processor | Nov 2012-June 2013 | — |
Countries
Australia, New Zealand
Contacts
Primary ContactRobert Cowan, PhD
Backup ContactValerie Looi, PhD
Outcome results
None listed