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
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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 | 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 |
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.
View NCT05552118 on ClinicalTrials.gov ↗ ← All trials in Italy