Innovations in Clinical Care of CE Approved Nucleus Cochlear Implant Recipients

Study Overview
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Brief Summary
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This study is to evaluate new approaches to device fitting and diagnostics for cochlear implant users. The evaluation can be performed in the laboratory in an acute session or in real world environments with take-home device use to further validate their benefits. Each feature will be tested in a sub-study specific to that hearing care model. On average, each sub-study is expected to include approximately 20 subjects.

Official Title
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A Feasibility, Prospective, Repeated-measures Investigation to Investigate Innovations in Clinical Care in Adult and Paediatric Recipients Implanted With CE Approved Nucleus Cochlear Implants: an Umbrella Investigation

Conditions
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Hearing Loss

Intervention / Treatment
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* Device: Cochlear Implant and sound processor device fitting paradigm or diagnostic/measurement technique
* Device: Standard of care fitting or diagnostic measurement of Cochlear Implant and sound processor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Group 1 subjects: Users of a CE approved Nucleus cochlear implant, resulting in open set speech understanding or Group 2 subjects: Subjects assessed by their CI clinic to be suitable for implantation with a commercially available CE approved Nucleus cochlear implant. Paediatrics: Older than 10 months and <18 years when entering the study (Belgium only) or Adults: ≥18 years when entering the study (Belgium and Australia) Subject/legally designated representative is fluent speaker in the language used for assessments. Willing and able to provide written informed consent (for paediatric populations this criterion applies to the parent/legally designated representative). Exclusion Criteria: Unable or unwilling to comply with the requirements of the clinical investigation as determined by the investigator. Additional health factors, known to the investigator, that would prevent or restrict participation in the audiological evaluations. Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling. Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this investigation. Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.

Ages Eligible for Study
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Minimum Age: 10 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational<br>Recipients of cochlear implant or suitable for implantation | Device: Cochlear Implant and sound processor device fitting paradigm or diagnostic/measurement technique<br>* Experimental: The investigational device will be a new device fitting paradigm or diagnostic/measurement technique implemented for use with the commercially available sound processor and implant.<br>|
| Active Comparator: Standard of Care<br>Recipients of cochlear implant or suitable for implantation | Device: Standard of care fitting or diagnostic measurement of Cochlear Implant and sound processor<br>* The comparator will be the standard of care fitting or diagnostic or measurement approach.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean difference between standard and novel fitting method for monosyllabic word scores in quiet | Percent correct word scores | 0 to 4 weeks after fitting |