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ACTIVE NOT RECRUITING
NCT05552118
NA

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

View on ClinicalTrials.gov

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

PROCEDURE

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.

PROCEDURE

Standard of care

Routine in clinic face-to-face care and sound processor programming using Cochlear™ Custom Sound® Pro

DEVICE

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