Comparing remote care to standard care for cochlear implant aftercare in adults
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
This study is testing if remote care for adults with cochlear implants is just as good as regular in-clinic care during the first year after their device is turned on.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 148 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cochlear Industry-sponsored |
| Locations | 10 sites (Gent and 9 other locations) |
| Trial ID | NCT05552118 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of remote care management for adults with cochlear implants during the first year after activation, specifically between 3 and 12 months post-activation. Participants will be managed using Cochlear's Remote Care tools, such as Remote Check and Remote Assist, and compared to those receiving standard in-clinic care. The study also aims to analyze the time and costs associated with both care models to identify potential savings and efficiency improvements in cochlear implant aftercare.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are post-lingually deafened and have been unilaterally implanted with specific cochlear implant models and are currently using compatible sound processors.
Not a fit: Patients with incompatible MAP settings or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more efficient and cost-effective aftercare for cochlear implant patients, improving their overall experience and outcomes.
How similar studies have performed: Other studies have shown promise in using remote care for managing cochlear implant aftercare, indicating that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Gent and 9 other locations
- UZ Gent — Gent, Belgium (Recruiting)
- UZ Leuven — Leuven, Belgium (Recruiting)
- University of Bari "A. Moro" UOC Otorinolaringoiatria Universitaria — Bari, Italy (Not_yet_recruiting)
- Azienda Ospedale Università di Padova — Padova, Italy (Not_yet_recruiting)
- Academisch Ziekenhuis Maastricht — Maastricht, Netherlands (Not_yet_recruiting)
- Radboud University Medical Centre Nijmegen — Nijmegen, Netherlands (Not_yet_recruiting)
- Queen Elizabeth Hospital Audiology Centre - University Hospital Birmingham — Birmingham, United Kingdom (Not_yet_recruiting)
- Auditory Implant Centre, Glan Clwyd Hospital — Bodelwyddan, United Kingdom (Recruiting)
- St Thomas' Hospital — London, United Kingdom (Recruiting)
- St George's Hospital — London, United Kingdom (Not_yet_recruiting)
Study contacts
- Study coordinator: PRS Specialist, Clinical Affairs
- Email: cltd-prs-admin@cochlear.com
- Phone: +61 2 9428 6555
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.