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| Name | Class |
|---|---|
| The HEARing Co-operative Research Centre, Melbourne | UNKNOWN |
| Melbourne Cochlear Implant Clinic, Melbourne | UNKNOWN |
| The Shepherd Centre, Sydney | UNKNOWN |
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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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N6 | Experimental | The N6 system comprises an investigational sound processor, remote assistant and fitting software |
|
| N5 | Active Comparator | The current commercially-available cochlear implant system Performance of N5 will be compared to performance with N6 using a within-subject design. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N6 | Device | Children with N5 will be upgraded to the N6 for a period of up to 2 months to evaluate. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Group usability performance data for N6 versus N5 | 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. | Nov 2012-June 2013 |
| Measure | Description | Time Frame |
|---|---|---|
| speech recognition scores in quiet and noise between the two processors | The CUNY sentences and CNC word lists will be administered in quiet and noise. | Nov 2012-June 2013 |
| Useability questionnaire on the different sound processing features |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robert Cowan, PhD | Contact | +61294286555 | r.cowan@unimelb.edu.au | |
| Valerie Looi, PhD | Contact | +61296115896 | vlooi@cochlear.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Shepherd Centre | Active, not recruiting | Sydney | New South Wales | 2008 | Australia | |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| Hear and Say Centre |
| OTHER |
| The Hearing House, Auckland | UNKNOWN |
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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
| Nov 2012-June 2013 |
| Subjective feedback on performance as well as patient preference between the 2 processors | 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. | Nov 2012-June 2013 |
| Evaluate the usability of the two systems in a group of children, their carers and their teachers | The information from the above questionnaires will be used to collectively compare the usability of the child's current processor and the N6 processor. | Nov 2012-June 2013 |
| Clinical recommendations for fitting paediatric recipients with the new processor | Nov 2012-June 2013 |
| Hear and Say Centre |
| Recruiting |
| Brisbane |
| Queensland |
| 4066 |
| Australia |
|
| Melbourne Cochlear Implant Clinic | Recruiting | Melbourne | Victoria | 3002 | Australia |
|
| The Hearing House | Recruiting | Auckland | New Zealand |
|
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |