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MED-EL Remote Care Multi-Center Feasibility Study

MED-EL Remote Care Multi-Center Feasibility Study

Recruiting
All
Phase N/A
  • Technical (Original)
  • Simplified (AI rewritten)

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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.

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.

Eligibility

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

NCT05973669

Med-El Corporation

15 October 2025

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FAQs

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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