Speech Performance and Clinic Efficiency With Remote Care Compared With Standard of Care in Adults With a Cochlear Implant in the First 12 Months Post-activation

Study Overview
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Brief Summary
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The aim of the study is to assess the real-world effectiveness of managing participants within the first year post-activation (between 3 and 12 months) using Cochlear's Remote Care (Remote Check and Remote Assist), as compared with standard in-clinic management. The study captures also the time and costs associated with both models of care to quantify the potential costs savings and efficiency gains possible with delivering Cochlear Implant (CI) aftercare remotely.

Official Title
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A Post-Market, Prospective, Multi-Centre, Open-Label, Comparative, Interventional Study of Adult Cochlear Implant Speech Performance and Clinic Efficiency With Remote Care (Remote Check & Remote Assist) Compared With Standard of Care in the First 12 Months Post-initial Activation

Conditions
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Hearing Loss

Intervention / Treatment
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* Procedure: Cochlear™ Remote care
* Procedure: Standard of care
* Device: Cochlear Implant CI600 Series, CI500 Series or Freedom Series and Sound processor Nucleus 7 or Kanso 2 (or latest compatible Sound Processor)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 years or older (no upper age limit) Post-lingually deafened Unilaterally implanted with the CI600 Series (CI612, CI622, CI632),CI500 Series (CI512, CI522, CI532) or Freedom Series (CI24RE(CA),CI24RE(ST), CI422) Currently using a Nucleus 7 (CP1000) or Kanso 2 (CP1050) Sound Processor (or latest compatible Sound Processor) 3 months, +/- 2 weeks, experience with a cochlear implant (post-activation) at the time of baseline measurements Owner of a compatible Smart Phone Fluent in the languages used for the study, as determined by the investigator Willing to participate in and comply with all requirements of the protocol, including willingness to be randomised to either arm Willing and able to provide written informed consent Exclusion Criteria: Patient has a MAP incompatible with Master Volume, Bass and Treble (MVBT) programming: Non-monopolar MAPs (bipolar, common ground, variable mode) Dynamic range of <10 Comfortable Level (CL) Hybrid mode enabled Pulse widths >100 µs 10 or more electrodes turned off Patient has on-going fluctuations in MAP Threshold levels (Ts) and Comfort levels (Cs) and/or impedances Patient requires frequent individual channel measurements and/or measurements without the use of live-stimulation Score below 3 on the screening subset of questions from the Mobile Device Proficiency Questionnaire (MDPQ) Abnormal cochlea anatomy and/or facial nerve stimulation Additional disabilities that would prevent participation in evaluations, including significant visual impairment and/or dexterity issues Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator 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 Organisations or contractors engaged by Cochlear for the purposes of this investigation Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation).

Ages Eligible for Study
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Minimum Age: 18 Years

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cochlear™ Remote care<br>Is composed of Cochlear™ Remote Check and Cochlear™ Remote Assist. | Procedure: Cochlear™ Remote care<br>* Cochlear™ Remote Check is a virtual assessment tool which helps the clinician to monitor the participant hearing progress remotely. It allows the participant to complete a series of hearing tests using the Cochlear™ Nucleus® Smart App then electronically send the results to the clinician for review. Cochlear™ Remote Assist enables a video call appointment through the Cochlear™ Custom Sound® Pro software and the Nucleus® Smart App. When remote check requires further follow-up, it allows the clinician to make programming adjustments and sound processor settings without a clinic visit.<br>Device: Cochlear Implant CI600 Series, CI500 Series or Freedom Series and Sound processor Nucleus 7 or Kanso 2 (or latest compatible Sound Processor)<br>* CI600 Series (CI612, CI622, CI632), CI500 Series (CI512, CI522, CI532), Freedom Series (CI24RE(CA), CI24RE(ST), CI422). Nucleus 7 (CP1000) or Kanso 2 (CP1050)<br>|
| Active Comparator: Standard of care<br>Routine In-clinic care | Procedure: Standard of care<br>* Routine in clinic face-to-face care and sound processor programming using Cochlear™ Custom Sound® Pro<br>Device: Cochlear Implant CI600 Series, CI500 Series or Freedom Series and Sound processor Nucleus 7 or Kanso 2 (or latest compatible Sound Processor)<br>* CI600 Series (CI612, CI622, CI632), CI500 Series (CI512, CI522, CI532), Freedom Series (CI24RE(CA), CI24RE(ST), CI422). Nucleus 7 (CP1000) or Kanso 2 (CP1050)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in patient reported hearing ability in daily life measured with the SSQ12 (Speech, Spatial and Qualities of Hearing Scale) questionnaire between month 3 (baseline) and month 12 post-activation | Measuring change of speech, spatial and hearing experiences (12 items). Each item is scored on a scale of 0 to 10 where 0 corresponds to complete inability or complete absence of a quality and 10 to complete ability or complete presence of an ability. The score of a participant is determined as the mean of the 12 items. Higher scores indicate less hearing disability | 3 months post-activation (baseline) and 12 months post-activation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in speech recognition score for an open-set word recognition measure in quiet between 3 months post-activation (baseline) and 12 months post-activation | The test is done using phonetically balanced words and scores are recorded as % correct words. Higher scores indicate a better outcome. | 3 months post-activation (baseline) and 12 months post-activation | 
| Mean change in speech recognition score for sentences in adaptive noise between 3 months post-activation (baseline) and 12 months post-activation | The test is done using validated lists of phonetically balanced sentences. The noise is kept constant at 65 decibel (dB) Sound Pressure Level (SPL), and the speech is adapted stepwise to establish the speech-to-noise ratio (SNR) providing a 50% level of understanding. Lower scores indicate a better outcome. | 3 months post-activation (baseline) and 12 months post-activation | 
| Descriptive summaries of clinic time and resource utilisation incurred between 3 months and 12 months post-activation assessed via a custom questionnaire. |  | 3 months post-activation (baseline) and 12 months post-activation | 
| Descriptive summaries of time and costs incurred by participants between 3 months and 12 months post-activation via a custom questionnaire |  | 3 months post-activation (baseline) and 12 months post-activation | 
| Participant satisfaction measured with the Client Satisfaction Questionnaire (CSQ)-8 at 12 months post-activation | Measuring satisfaction of participants with the healthcare service (8 questions). Each item is scored using a 4-point Likert scale with 1 always indicating a negative response and 4 a positive response. A total higher score indicates higher satisfaction | 12 months post-activation | 
| Participant empowerment measured with the Patient Activation Measure (PAM), at 12 months post-activation | Evaluating the knowledge, skills, beliefs, and behaviours that participants have for self-management of their long-term health condition (13 items). Each item is scored on a 4-point likert scale from 1 (strongly disagree) to 4 (strongly agree). The overall score is calculated and normalized to a 100-point scale. Higher scores indicate greater levels of activation. | 12 months post-activation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cochlear Implant aftercare, Remote clinical management