MED-EL Remote Care Multi-Center Feasibility Study

Last updated: June 3, 2025
Sponsor: Med-El Corporation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Deafness

Hearing Aid

Hearing Impairment

Treatment

MED-EL Remote Care

Clinical Study ID

NCT05973669
US2302 MED-EL Remote Care
  • All Genders
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

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 wordscores, 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

Exclusion Criteria:

  • Inability or unwillingness to perform the requirements of the clinical investigation

  • Unrealistic expectations regarding the possible benefits, risks, and limitations ofremote cochlear implant care

  • Inability of the subject or caregiver to demonstrate basic skills for operating asmartphone, computer, or app-based tasks after training by the investigator

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: MED-EL Remote Care
Phase:
Study Start date:
November 05, 2024
Estimated Completion Date:
May 31, 2026

Study 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.

Connect with a study center

  • London Health Sciences Centre

    London, Ontario N6A 5A5
    Canada

    Site Not Available

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario M4N 3M5
    Canada

    Site Not Available

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • University of Michigan

    Ann Arbor, Michigan 48108
    United States

    Active - Recruiting

  • University of North Carolina

    Chapel HIll, North Carolina 27599
    United States

    Active - Recruiting

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