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Evaluation of Remote Programming of Cochlear Implants in Routine Cochlear Implant Follow-up
Sponsor: Advanced Bionics AG
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 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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
51
Start Date
2025-02-03
Completion Date
2026-12
Last Updated
2025-03-25
Healthy Volunteers
No
Conditions
Interventions
Target CI v1.5 remote programming
Use of the remote programming function of Target CI v1.5 and the AB remote support application
Locations (1)
Groupement Hospitalier Pitié Salpêtrière
Paris, France