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Enrolling by Invitation

NCT Number: NCT05973669

MED-EL Remote Care Multi-Center Feasibility Study

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.

Enrolling by Invitation

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Key information

Conditions

Hearing Loss, Sensorineural Cochlear Implant Cochlear Implant Recipients Cochlear Implants Ear Diseases Hearing Disorders Hearing Loss Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

London Health Sciences Centre, London, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MED-EL Remote Care

Device

Remote cochlear implant support

Primary outcomes

  1. Remote Care Completion

    Time frame: Up to 6 months post-training

    Number and proportion of fully completed Remote Care visits.

Secondary outcomes

  1. 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.

  2. Patient cost estimates

    Time frame: Up to 6 months post-training

    Descriptive summaries of patient-estimated costs associated with attending an in-clinic appointment.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Med-El Corporation

Industry

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 3, 2023
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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