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
Cochlear™ Remote careStandard of careCompatible Implant Series and Compatible Sound Processors
Cochlear™ Remote care: 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.
Standard of care: Routine in clinic face-to-face care and sound processor programming using Cochlear™ Custom Sound® Pro
Compatible Implant Series and Compatible Sound Processors: Individuals who are implanted with a compatible cochlear implant series and compatible sound processor are eligible to participate.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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).
Primary outcome measure(s)
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 — 3 months post-activation (baseline) and 12 months 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
Trial sites (11)
Facility
City
Region
Status
Ear Science Institute Australia
Subiaco
Western Australia
UZ Gent
Ghent
Belgium
UZ Leuven
Leuven
Belgium
University of Bari "A. Moro" UOC Otorinolaringoiatria Universitaria
Bari
Italy
Azienda Ospedale Università di Padova
Padova
Italy
Academisch Ziekenhuis Maastricht
Maastricht
Netherlands
Radboud University Medical Centre Nijmegen
Nijmegen
Netherlands
Queen Elizabeth Hospital Audiology Centre - University Hospital Birmingham
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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