Remote care for cochlear implant users
MED-EL Remote Care Multi-Center Feasibility Study
NA · Med-El Corporation · NCT05973669
This study tests a new remote care system for cochlear implant users to see if it helps them monitor their hearing and device without needing to go to appointments.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Sex | All |
| Sponsor | Med-El Corporation (industry) |
| Locations | 5 sites (Iowa City, Iowa and 4 other locations) |
| Trial ID | NCT05973669 on ClinicalTrials.gov |
What this trial studies
This study evaluates the MED-EL Remote Care system, allowing cochlear implant users to monitor their hearing and device functionality without needing in-person appointments. It is a prospective multicenter study involving participants from the US and Canada. The focus is on assessing the effectiveness, efficiency, and usability of this remote care approach for cochlear implant recipients.
Who should consider this trial
Good fit: Ideal candidates are individuals who have been implanted with a MED-EL cochlear implant and can use a compatible smartphone for remote assessments.
Not a fit: Patients who are unable or unwilling to use a smartphone or those with unrealistic expectations regarding remote care may not benefit from this study.
Why it matters
Potential benefit: If successful, this could provide cochlear implant users with greater accessibility and convenience in managing their hearing health.
How similar studies have performed: Other studies have shown promise in telehealth approaches for cochlear implant management, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Implanted with at least one MED-EL cochlear implant * ≥ 2 weeks since activation of the cochlear implant * Availability of existing aided Pediatric/AZ Bio (quiet and/or noise) and CNC word scores, or the ability to complete these at baseline * Utilizing a compatible audio processor in the SONNET or RONDO product lines * Ability to complete app-based hearing assessments * Commitment to comply with all study procedures for the duration of the study * Access to the internet via a smartphone that meets the following requirements: * Android or iOS operating systems * A smartphone supporting Bluetooth® 4.2 or higher * A minimum of 200 MB free storage space Exclusion Criteria: * Inability or unwillingness to perform the requirements of the clinical investigation * Unrealistic expectations regarding the possible benefits, risks, and limitations of remote cochlear implant care * Inability of the subject or caregiver to demonstrate basic skills for operating a smartphone, computer, or app-based tasks after training by the investigator
Where this trial is running
Iowa City, Iowa and 4 other locations
- University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States (RECRUITING)
- University of Michigan — Ann Arbor, Michigan, United States (NOT_YET_RECRUITING)
- University of North Carolina — Chapel HIll, North Carolina, United States (NOT_YET_RECRUITING)
- London Health Sciences Centre — London, Ontario, Canada (NOT_YET_RECRUITING)
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: MED-EL Corporation
- Email: research.us@medel.com
- Phone: 1-888-633-3524
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hearing Loss, Sensorineural, Cochlear Implant, Cochlear Implant Recipients, Hearing Disorders, Cochlear Implants, cochlear implants, telehealth, remote care