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Clinical Trials in the UK / NCT05552118
Active, not recruiting Not applicable

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

NCT05552118 · tracked via the Priya Life Science UK tracker
Sponsor
Cochlear
Phase
Not applicable
Started
2024-03-18
Last updated
2026-01-16

Condition(s) studied

Hearing Loss

Investigational drug(s) / intervention(s)

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)

Trial sites (11)

FacilityCityRegionStatus
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

More Cochlear trials in the UK

Other trials for the same condition

Official registry record

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 the UK