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

Launched by COCHLEAR · Sep 20, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring how effective remote care is for adults with cochlear implants during their first year after activation. Specifically, it compares two methods: traditional in-clinic visits and remote care options like Cochlear's Remote Check and Remote Assist. The study aims to understand which approach not only helps improve speech performance but also saves time and money for patients and healthcare providers.

To participate, you need to be at least 18 years old and have received a specific type of cochlear implant (like the CI600 or CI500 series) within the last three months. You should also be using a compatible sound processor and own a smartphone. If you join the study, you'll be randomly assigned to one of the two care methods. Throughout the trial, you'll help researchers gather information to potentially make cochlear implant aftercare more efficient and accessible for everyone.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Aged 18 years or older (no upper age limit)
• • Post-lingually deafened or pre-lingually deafened with measurable word scores in quiet using a cochlear implant
• • Unilaterally implanted with a compatible Cochlear™ implant
• • Currently using a compatible Cochlear™ Sound Processor
• • 3 months, +/- 2 weeks, experience with a cochlear implant (post-activation) at the time of baseline measurements
• • Direct access to 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 that requires complex or more frequent programming, as determined by the Investigator
• • 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).