Actively Recruiting
Evaluation of Remote Programming of Cochlear Implants in Routine Cochlear Implant Follow-up
Led by Advanced Bionics AG · Updated on 2025-03-25
51
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective and monocentric clinical investigation, non-interventional and non-randomized. The overall goal of this clinical study is to generate additional clinical data confirming the safety and efficacy of the remote programming functionality of Target CI version 1.5 and the AB Remote Support app. Hearing outcomes are expected to be similar whether a study subject's sound processor is programmed in the traditional method in the audiologist's office or whether programming is performed via remote fitting. Therefore, the study uses a non-inferiority design to determine whether sentence recognition in noise is no worse with remote fitting than in an in-office setting.
CONDITIONS
Official 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 or HiRes 90K Advantage or HiRes Ultra or HiRes Ultra 3D) on at least one side
- Group 1: Unilateral with no hearing device except contralateral routing of signals (CROS) device on the other side
- Group 2: Bilateral implant on both sides
- Group 3: Bimodal with hearing aid on the contralateral side
- Minimum of six months of cochlear implant experience
- Minimum of one month experience with a Nad CI M or Sky CI M sound processor
- Fluent in French language
- Ability to be tested via speech perception test in noise
- Smartphone user
You will not qualify if you...
- Clinical signs suggesting possible implanted device malfunction
- Unrealistic expectations about benefits, risks, or limitations of the investigational device as determined by the Investigator
- Unwillingness or inability to comply with all study requirements as determined by the Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
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