Cochlear Implant Clinical Care - Evaluation of new methods for sound processor fitting, performance measurement and intra-operative testing in Nucleus Cochlear Implant recipients, compared to existing clinical software

Not Applicable

• Conditions: Cochlear Implantation; Other - Research that is not of generic health relevance and not applicable to specific health categories listed above; Ear - Deafness

• Registration Number: ACTRN12613001010785
• Lead Sponsor: Cochlear Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-11
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

Implanted or assessed to be suitable for implantation with a commercially available Nucleus implant, resulting in measurable open set speech understanding.

Exclusion Criteria

1.Unwillingness or inability of the candidate to comply with all investigational requirements
2.Additional handicaps that would prevent or restrict participation in the audiological evaluations

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Group 1: Speech perception scores for CNC word test and Austin test with new software is not significantly different from the current software.[Group 1, performance measurement stage: Within the first fitting session when the new programs are fitted and then evaluated once in 2 weeks for up to 12 weeks if the participant is asked to use the programs at home.];Group 2, Intra-operative testing: The objective test results like NRT thresholds and impedance measurement results with new software and hardware is comparable to the current software. [Group 2, Intra-operative testing: During surgery, the set of measurements obtained with the new system will be compared to the the same obtained with the current software. ]

Secondary Outcome Measures

Name	Time	Method
Group 1, Usability stage: Ease of use of new software is same or better than current software. The participants will be monitored for their ability to complete the tasks required of them with the training provided without the need for additional help.[Group 1, Usability stage: The usability observations with the new system will be compared with the ease of use with the current software in same clinical session when the software is used. ]