Remote Support for Cochlear Implant Recipients: Evaluation of the HearCare MED-EL App

Launched by MED-EL ELEKTROMEDIZINISCHE GERÄTE GESMBH · Aug 5, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the HearCare MED-EL App, which is designed to help people who have received MED-EL cochlear implants manage their hearing loss remotely. The goal is to evaluate how safe and effective this app is for users, allowing them to control and monitor their hearing devices from the comfort of their own homes.

To participate in this trial, individuals must be at least 18 years old and have had a MED-EL cochlear implant for at least three months. They also need to use a compatible audio processor, such as the SONNET 2 or RONDO 3. Participants will be asked to sign a consent form before starting the study. Those with certain medical conditions or specific types of implants may not be eligible. If you join the trial, you can expect to use the app to help with your hearing management, and you'll be contributing to important research that could improve remote support for cochlear implant users in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age \> 18 years
• • Implanted with at least one MED-EL Cochlea Implant (CI) for at least 3 months
• • Fitted with at least one audio processor compatible with the HearCare MED-EL App (i.e. SONNET 2, SONNET 2 EAS, RONDO 3 or newer)
• • Signed and dated Informed Consent Form (ICF) before the start of any study-specific procedure
• Exclusion Criteria:
• • Lack of compliance with any inclusion criteria
• • Implanted with C40X and C40C
• • Implanted with an Auditory Brainstem Implant (ABI) or Split electrode array
• • Anything that, in the opinion of the Investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study (e.g. psychological disorders, neurologic or motoric comorbidity that could restrict subjects from using the app)