MED-EL Remote Care Multi-Center Feasibility Study

MED-EL Remote Care Multi-Center Feasibility Study

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.

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.

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