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MED-EL Remote Care Multi-Center Feasibility Study

Status: Enrolling_by_invitation
Location: See all (5) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: t
View:

• 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

Locations
United States
Iowa
University of Iowa Hospitals and Clinics
Iowa City
Michigan
University of Michigan
Ann Arbor
North Carolina
University of North Carolina
Chapel Hill
Other Locations
Canada
London Health Sciences Centre
London
Sunnybrook Health Sciences Centre
Toronto
Time Frame
Start Date: 2024-11-05
Completion Date: 2026-11
Participants
Target number of participants: 50
Treatments
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: Med-El Corporation

This content was sourced from clinicaltrials.gov