Status:
RECRUITING
MED-EL Remote Care Multi-Center Feasibility Study
Lead Sponsor:
Med-El Corporation
Conditions:
Hearing Loss, Sensorineural
Cochlear Implant
Eligibility:
All Genders
Phase:
NA
Brief Summary
MED-EL Remote Care is a way for MED-EL cochlear implant users to check their hearing and cochlear implant device from any location, without the need for a scheduled, in-person appointment with their a...
Detailed Description
This prospective multicenter study will include MED-EL cochlear implant users from the US and Canada. This study will assess the effectiveness, efficiencies, and useability of MED-EL Remote Care.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05973669
Start Date
November 5 2024
End Date
May 1 2026
Last Update
June 6 2025
Active Locations (5)
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1
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
2
University of Michigan
Ann Arbor, Michigan, United States, 48108
3
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
4
London Health Sciences Centre
London, Ontario, Canada, N6A 5A5