MED-EL Remote Care Multi-Center Feasibility Study

Not Applicable

Recruiting

• Conditions: Hearing Loss, Sensorineural; Cochlear Implant; Cochlear Implant Recipients; Hearing Disorders; Cochlear Implants
• Interventions: Device: MED-EL Remote Care

• Registration Number: NCT05973669
• Lead Sponsor: Med-El Corporation

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-07-14
• Study First Submitted QC: 2023-07-25
• Study First Posted: 2023-08-03
• Status Verified: 2024-11
• Study Start: 2024-11-05
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-20
• Primary Completion: 2025-11
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Remote cochlear implant support	MED-EL Remote Care	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.

Primary Outcome Measures

Name	Time	Method
Remote Care Completion	Up to 6 months post-training	Number and proportion of fully completed Remote Care visits.

Secondary Outcome Measures

Name	Time	Method
Patient time savings	Up to 6 months post-training	Average time estimates associated with attending an in-clinic appointment compared to Remote Care completion time.
Patient cost estimates	Up to 6 months post-training	Descriptive summaries of patient-estimated costs associated with attending an in-clinic appointment.
Clinician time savings	Up to 6 months post-training	Average clinician-reported time estimates associated with in-clinic appointments compared to Remote Care completion time.
Patient Feedback Survey	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.
Clinician Feedback Survey	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.
Remote hearing assessments	Up to 6 months post-training	Average remote hearing assessment results compared to standard aided test results obtained at baseline.

Trial Locations

Locations (5)

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

University of North Carolina; 🇺🇸 Chapel HIll, North Carolina, United States

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada