MED-EL Remote Care Multi-Center Feasibility Study
Launched by MED-EL CORPORATION · Jul 25, 2023
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
The MED-EL Remote Care Multi-Center Feasibility Study is looking at a new way for people with MED-EL cochlear implants to manage their hearing from home. Instead of needing to visit an audiologist in person for check-ups, this study will see how effective and user-friendly the Remote Care app is for monitoring hearing and the cochlear implant device. This could make it easier for patients to stay connected with their hearing health.
To join the study, participants must have at least one MED-EL cochlear implant and have had it activated for at least two weeks. They also need to have a smartphone that can connect to the internet and meet certain technical requirements. Participants will use the app to complete hearing assessments and will need to follow the study rules for its duration. This study is currently recruiting, and it offers a great opportunity for cochlear implant users to take part in something that could improve how they manage their hearing care.
Gender
ALL
Eligibility criteria
- 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
About Med El Corporation
MED-EL Corporation is a leading innovator in the field of hearing solutions, dedicated to advancing the quality of life for individuals with hearing loss through cutting-edge medical devices. Established in 1989, the company specializes in the development and manufacturing of implantable hearing systems, including cochlear implants and bone conduction devices. With a strong commitment to research and clinical excellence, MED-EL actively engages in clinical trials to evaluate the safety and efficacy of its products, ensuring that patients receive the most effective treatment options. The company's mission is to break down communication barriers and empower individuals to connect with the world around them.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Iowa City, Iowa, United States
Chapel Hill, North Carolina, United States
Toronto, Ontario, Canada
London, Ontario, Canada
Ann Arbor, Michigan, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported