MED-EL Remote Care Multi-Center Feasibility Study

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.

Conditions

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

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Study Overview

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Study Details

Study overview

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.

MED-EL Remote Care Multi-Center Feasibility Study

MED-EL Remote Care Multi-Center Feasibility Study

Condition
Hearing Loss, Sensorineural
Intervention / Treatment

-

Contacts and Locations

Iowa City

University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States, 52242

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48108

Chapel HIll

University of North Carolina, Chapel HIll, North Carolina, United States, 27599

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Med-El Corporation,

Study Record Dates

2026-05