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

INTERVENTION: Cochlear implant (CI) restores hearing for people with bilateral severe to profound hearing loss. Clinicians use clinical software to a) Perform intra‐operative testing to evaluate the success of the surgery b) Perform sound processor fitting (also known as MAPping or Programming) to provide optimum performance with the cochlear implant for the recipient c) Perform performance tests evaluate the benefit of the cochlear implant for the CI recipient. With the current clinical software, extensive training is required for the clinician to use the software effectively. The study evaluates new versions of clinical software for Sound processor fitting, performance measurement and Intra‐operative testing that improves the ease of use for clinicians and CI recipients. The new software has user interface improvements to improve the intuitiveness of the steps to be followed by the clinician making it easier to learn and easy to use. The study will be conducted with two groups of participants based on whether they are already using an implant (Group 1) or are a candidate for a CI and are scheduled for a surgery (Group 2). Group 1: Sound processor fitting and performance measurement will be conducted in clinical sessions with participants who have already been implanted with a CI. A usability stage and a performance measurement stage will be conducted. For each stage participants will be randomly selected. At the usability stage the new software will be used for sound processor fitting, performance measurement with the recipients. The usability of the new software will be assessed in a clinical session typically lasting 2 hours. The participant will not be required to perform tasks outside the clinical session. At the performance measurement stage the new software will be used for sound processor fitting, with the participants and new programs will be created. The participant's sound processor will be loaded with the programs created by the new software (new program) and also programs created with the current software (current program). The participant will be asked to alternate the use of the new program and the current program on a daily basis for up to 12 weeks and the performance will be assessed in up to 6 clinical sessions. The order of the program used will be randomised and the participant will be blind to the identity of the programs. A daily diary will be used to monitor the participant's adherence to the daily alternation of programs. Each session would last for 2 hours. The study will use a repeated measures design where the recipient will be their own control. Group 2: The new software will be used for intra‐operative testing during CI surgery and the results with the new software will be compared with the current software. No study related activities are required by the participants after the surgery. CONDITION: Cochlear Implantation PRIMARY OUTCOME: Group 1: Speech perception scores for CNC word test and Austin test with new software is not significantly different from the current software. 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. INCLUSION CRITERIA: Implanted or assessed to be suitable for implantation with a commercially available Nucleus implant, resulting in measurable open set speech understanding. SECONDARY OUTCOME: 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.