MED-EL Remote Care Multi-Center Feasibility Study

April 13, 2026 updated by: Med-El Corporation
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • London Health Sciences Centre
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre
  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Michigan
      • Ann Arbor, Michigan, United States, 48108
        • University of Michigan
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina

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.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: MED-EL Remote Care
Remote cochlear implant support

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Remote Care Completion
Time Frame: Up to 6 months post-training
Number and proportion of fully completed Remote Care visits.
Up to 6 months post-training

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinician time savings
Time Frame: Up to 6 months post-training
Average clinician-reported time estimates associated with in-clinic appointments compared to Remote Care completion time.
Up to 6 months post-training
Patient Feedback Survey
Time Frame: Up to 6 months post-training
Subject satisfaction measured using a custom questionnaire administered after each use of Remote Care. Each item is scored using a 5-point Likert scale with 1 always indicating a negative response and 5 a positive response. A total higher score indicates higher satisfaction.
Up to 6 months post-training
Clinician Feedback Survey
Time Frame: Mid-enrollment to enrollment completion
Clinician satisfaction measured using a custom questionnaire administered at mid-enrollment and at study completion. Each item is scored using a 5-point Likert scale with 1 always indicating a negative response and 5 a positive response. A total higher score indicates higher satisfaction.
Mid-enrollment to enrollment completion
Remote hearing assessments
Time Frame: Up to 6 months post-training
Average remote hearing assessment results compared to standard aided test results obtained at baseline.
Up to 6 months post-training
Patient time savings
Time Frame: Up to 6 months post-training
Average time estimates associated with attending an in-clinic appointment compared to Remote Care completion time.
Up to 6 months post-training
Patient cost estimates
Time Frame: Up to 6 months post-training
Descriptive summaries of patient-estimated costs associated with attending an in-clinic appointment.
Up to 6 months post-training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Med-El Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

November 5, 2024

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

July 14, 2023

First Submitted That Met QC Criteria

July 25, 2023

First Posted (Actual)

August 3, 2023

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • US2302 MED-EL Remote Care

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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