RECRUITING

MED-EL Remote Care Multi-Center Feasibility Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

MED-EL Remote Care Multi-Center Feasibility Study

Quick Facts

Study Start:2024-11-05
Study Completion:2026-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05973669

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Implanted with at least one MED-EL cochlear implant
  2. * ≥ 2 weeks since activation of the cochlear implant
  3. * Availability of existing aided Pediatric/AZ Bio (quiet and/or noise) and CNC word scores, or the ability to complete these at baseline
  4. * Utilizing a compatible audio processor in the SONNET or RONDO product lines
  5. * Ability to complete app-based hearing assessments
  6. * Commitment to comply with all study procedures for the duration of the study
  7. * Access to the internet via a smartphone that meets the following requirements:
  8. * Android or iOS operating systems
  9. * A smartphone supporting Bluetooth® 4.2 or higher
  10. * A minimum of 200 MB free storage space
  1. * Inability or unwillingness to perform the requirements of the clinical investigation
  2. * Unrealistic expectations regarding the possible benefits, risks, and limitations of remote cochlear implant care
  3. * Inability of the subject or caregiver to demonstrate basic skills for operating a smartphone, computer, or app-based tasks after training by the investigator

Contacts and Locations

Study Contact

MED-EL Corporation
CONTACT
1-888-633-3524
research.us@medel.com

Study Locations (Sites)

University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
United States
University of Michigan
Ann Arbor, Michigan, 48108
United States
University of North Carolina
Chapel HIll, North Carolina, 27599
United States

Collaborators and Investigators

Sponsor: Med-El Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-05
Study Completion Date2026-05

Study Record Updates

Study Start Date2024-11-05
Study Completion Date2026-05

Terms related to this study

Keywords Provided by Researchers

  • cochlear implants
  • telehealth
  • remote care

Additional Relevant MeSH Terms

  • Hearing Loss, Sensorineural
  • Cochlear Implant
  • Cochlear Implant Recipients
  • Hearing Disorders
  • Cochlear Implants