MED-EL Remote Care Multi-Center Feasibility Study

MED-EL

Status: Enrolling

Conditions: Hearing Disorders; Cochlear Implant Recipients; Cochlear Implant; Cochlear Implants; Hearing Loss, Sensorineural

Treatments: Device: MED-EL Remote Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT05973669

US2302 MED-EL Remote Care

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Remote cochlear implant support

Experimental group

Description:

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.

Treatment:

Device: MED-EL Remote Care