Status:
RECRUITING
Evaluation of Remote Programming of Cochlear Implants in Routine Cochlear Implant Follow-up
Lead Sponsor:
Advanced Bionics AG
Conditions:
Cochlear Hearing Loss
Eligibility:
All Genders
18+ years
Brief Summary
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 safe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 3 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT06894303
Start Date
February 3 2025
End Date
December 1 2026
Last Update
March 25 2025
Active Locations (1)
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1
Groupement Hospitalier Pitié Salpêtrière
Paris, France, 75013