Active, not recruitingNo phase
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
Key facts
- Who runs it
- Cochlear
- Where
- Australia, Belgium, Italy, Netherlands, and United Kingdom11 sites in 5 countriesChoose a country to see its sites
- Trial code
- Status
- Active, not recruiting
- People taking part
- 148 people, planned
- Started
- 18 Mar 2024
- Ended
- Sept 2026
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Cochlear™ Remote care
- Standard of care
- Compatible Implant Series and Compatible Sound Processors
- Record updated
- 16 January 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 19 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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)
- Additional disabilities that would prevent participation in evaluations, including significant visual impairment and/or dexterity issues
- 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
- 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
This trial has no sites in United States.
It has sites in 5 countries. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Cochlear™ Remote careTreatment being tested
Is composed of Cochlear™ Remote Check and Cochlear™ Remote Assist.
Treatment: Cochlear™ Remote care and Compatible Implant Series and Compatible Sound Processors
- Standard of careExisting treatment, for comparison
Routine In-clinic care
Treatment: Standard of care and Compatible Implant Series and Compatible Sound Processors
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Record updated
- 16 January 2026