MED-EL Remote Care Multi-Center Feasibility Study (NCT05973669) | Clinical Trial Compass
By InvitationNot Applicable
MED-EL Remote Care Multi-Center Feasibility Study
United States, Canada50 participantsStarted 2024-11-05
Plain-language 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 audiologist. This study will assess the effectiveness, efficiencies, and useability of MED-EL Remote Care.
Who can participate
SexALL
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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