MED-EL Remote Care Multi-Center Feasibility Study
Overview
- Phase
- Not Applicable
- Intervention
- MED-EL Remote Care
- Conditions
- Hearing Loss, Sensorineural
- Sponsor
- Med-El Corporation
- Enrollment
- 50
- Locations
- 6
- Primary Endpoint
- Remote Care Completion
- Status
- Enrolling By Invitation
- Last Updated
- 16 days ago
Overview
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 audiologist. This study will assess the effectiveness, efficiencies, and useability of MED-EL Remote Care.
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.
Investigators
Eligibility 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
Arms & Interventions
Remote cochlear implant support
Participants will use MED-EL Remote Care to test their hearing and device functionality. Participants and clinicians will complete user feedback surveys regarding their experience and time/cost-savings.
Intervention: MED-EL Remote Care
Outcomes
Primary Outcomes
Remote Care Completion
Time Frame: Up to 6 months post-training
Number and proportion of fully completed Remote Care visits.
Secondary Outcomes
- Patient time savings(Up to 6 months post-training)
- Patient cost estimates(Up to 6 months post-training)
- Clinician time savings(Up to 6 months post-training)
- Patient Feedback Survey(Up to 6 months post-training)
- Clinician Feedback Survey(Mid-enrollment to enrollment completion)
- Remote hearing assessments(Up to 6 months post-training)