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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
Sponsor: Cochlear
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
148
Start Date
2024-03-18
Completion Date
2026-09
Last Updated
2026-01-16
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (11)
Ear Science Institute Australia
Subiaco, Western Australia, 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
Birmingham, United Kingdom
Auditory Implant Centre, Glan Clwyd Hospital
Bodelwyddan, United Kingdom
St Thomas' Hospital
London, United Kingdom
St George's Hospital
London, United Kingdom