Evaluation of Remote Programming of Cochlear Implants in Routine Cochlear Implant Follow-up

Launched by ADVANCED BIONICS AG · Mar 19, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to adjust cochlear implants remotely, using an app, instead of doing it in person at the audiologist's office. The goal is to see if people can hear just as well with remote programming as they do with the traditional method. Researchers want to find out if using this technology is safe and effective for people with cochlear hearing loss.

To participate in this study, you need to be at least 18 years old, fluent in French, and have a specific type of cochlear implant. You should also be comfortable using a smartphone and have been using your cochlear implant for at least six months. During the trial, participants will provide feedback on their hearing experiences and take speech perception tests in different noise environments. It's important to know that being pregnant or breastfeeding does not disqualify you from joining the study. Overall, this trial aims to improve how cochlear implants are managed and to ensure that remote programming is just as effective as in-person visits.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Ability to provide informed consent
• • Ability to give feedback on hearing impressions
• • Aged 18 years of age or older
• • Implanted with a HiResolution Bionic Ear System (HiRes 90K or HiRes 90K Advantage or HiRes Ultra or HiRes Ultra 3D) on at least one side
• • Group 1 - Unilateral: no hearing device except contralateral routing of signals (CROS) device on the contralateral side
• • Group 2 - Bilateral: implanted on both sides
• • Group 3 - Bimodal: hearing aid on the contralateral side
• • Minimum of six months of cochlear implant experience
• • Minimum of one month experience with a Naída CI M or Sky CI M sound processor
• • Fluent in French language
• • Ability to be tested via speech perception test in noise
• • Smartphone user
• Exclusion Criteria:
• • Clinical presentation indicative of potential implanted device malfunction
• • Unrealistic expectations regarding potential benefits, risks and limitations of the investigational device as determined by the Investigator
• • Unwillingness or inability of subject to comply with all investigational requirements as determined by the Investigator
• • Pregnancy and breast-feeding are not exclusion criteria.