Actively Recruiting
Evaluation of Remote Programming of Cochlear Implants in Routine Cochlear Implant Follow-up
Led by Advanced Bionics AG · Updated on 2026-05-20
51
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to gather additional clinical data on the safety and effectiveness of remote programming for cochlear implants using Target CI version 1.5 and the AB Remote Support app. The study focuses on adults with cochlear hearing loss who use specific HiResolution Bionic Ear Systems. It compares traditional in-office programming with remote fitting to see if hearing outcomes, especially sentence recognition in noise, are similar. Participants will use the remote programming function of Target CI v1.5 along with the AB Remote Support application. The study groups include unilateral cochlear implant users, bilateral users, and bimodal users who have a hearing aid on the other side. The remote programming is evaluated after at least one month of chronic use of the remotely fitted sound processor. Throughout the study, participants will be tested on their ability to recognize sentences in noise using the French Matrix test, as well as their scores on the Lafon phoneme test in quiet. Participants must be fluent in French and smartphone users to engage in the remote programming. Data will be collected to assess hearing outcomes and confirm that remote fitting is no worse than traditional in-office programming. The study is expected to conclude in December 2026.
CONDITIONS
Brief Title
Evaluation of Remote Programming of Cochlear Implants in Routine Cochlear Implant Follow-up
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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, HiRes 90K Advantage, HiRes Ultra, or HiRes Ultra 3D) on at least one side
- Group 1: Unilateral users with no hearing device except a contralateral routing of signals (CROS) device on the other side
- Group 2: Bilateral users implanted on both sides
- Group 3: Bimodal users with a 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
- Ability to be tested via speech perception test in noise
- Smartphone user
You will not qualify if you...
- Signs of possible implanted device malfunction
- Unrealistic expectations about the benefits, risks, or limitations of the investigational device as judged by the investigator
- Unwillingness or inability to follow all study requirements as judged by the investigator
- Pregnancy and breastfeeding are not exclusion criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 month
Participants experience the use of the remote programming function of their cochlear implant sound processor.
1 baseline visit and 1 follow-up visit
Duration - Up to 12 months
Participants are observed during routine cochlear implant follow-up with remote programming.
Periodic follow-up visits as part of routine care
Trial Site Locations
Total: 1 location
1
Groupement Hospitalier Pitié Salpêtrière
Paris, France, 75013
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here