RecruitingNot ApplicableNCT05973669

MED-EL Remote Care Multi-Center Feasibility Study

Sponsor

Med-El Corporation

Enrollment

50 participants

Start Date

Nov 5, 2024

Study Type

INTERVENTIONAL

Conditions

Hearing Loss, Sensorineural

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.

Eligibility

Inclusion Criteria10

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 Criteria3

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

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Interventions

DEVICEMED-EL Remote Care

Remote cochlear implant support

Locations(5)

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

London Health Sciences Centre

London, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

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NCT05973669

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