MED-EL Remote Care Multi-Center Feasibility Study
Completed · Not applicable
Conditions studied: Hearing Loss, Sensorineural, Cochlear Implant, Cochlear Implant Recipients, Hearing Disorders, Cochlear Implants
In brief
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 audiologist. This study will assess the effectiveness, efficiencies, and useability of MED-EL Remote Care.
Key facts
- Study ID
- NCT05973669
- Run by
- Med-El Corporation
- People needed
- 53
- Starts
- 2024-11-05
- Expected to finish
- 2026-05-11
- Last updated by the study team
- 2026-07-31
Who can join
Age: any. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 it is running
- University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
- University of Michigan — Ann Arbor, Michigan, United States
- University of North Carolina — Chapel Hill, North Carolina, United States
- London Health Sciences Centre — London, Ontario, Canada
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada
Full record on ClinicalTrials.gov
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