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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | June 2013 |
Est. primary completion date | June 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 5 Years to 14 Years |
Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Hear and Say Centre | Brisbane | Queensland |
Australia | Melbourne Cochlear Implant Clinic | Melbourne | Victoria |
Australia | The Shepherd Centre | Sydney | New South Wales |
New Zealand | The Hearing House | Auckland |
Lead Sponsor | Collaborator |
---|---|
Cochlear, Asia Pacific | Hear and Say, Brisbane, Melbourne Cochlear Implant Clinic, Melbourne, The HEARing Co-operative Research Centre, Melbourne, The Hearing House, Auckland, The Shepherd Centre, Sydney |
Australia, New Zealand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | 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 | No |
Secondary | Useability questionnaire on the different sound processing features | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | Clinical recommendations for fitting paediatric recipients with the new processor | Nov 2012-June 2013 | No |
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