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CompletedNo phase

MED-EL Remote Care Multi-Center Feasibility Study

Key facts

Who runs it
Med-El Corporation
Where
Ann Arbor, Chapel Hill, and Iowa City, United StatesSee the 3 sitesAlso in 1 other country, 2 sites
Trial code
Status
Completed
People taking part
53 people enrolled
Started
5 Nov 2024
Ended
11 May 2026
Type of study
Interventional
Treatments tested
  • MED-EL Remote Care
Record updated
31 July 2026

Who can take part

Sex
Women and men
Healthy volunteers
Can take part

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Unrealistic expectations regarding the possible benefits, risks, and limitations of remote cochlear implant care
  • Inability or unwillingness to perform the requirements of the clinical investigation
  • Inability of the subject or caregiver to demonstrate basic skills for operating a smartphone, computer, or app-based tasks after training by the investigator

Where in United States

Also in 1 other country, 2 sites

  • University of MichiganAnn Arbor, United StatesNo longer taking part
  • University of North CarolinaChapel Hill, United StatesNo longer taking part
  • University of Iowa Hospitals and ClinicsIowa City, United StatesNo longer taking part

About the trial

What the trial wants to find out

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.

The group in the trial

  • Remote cochlear implant supportTreatment being tested

    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.

    Treatment: MED-EL Remote Care

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Record updated
31 July 2026