Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2025-12-24 @ 5:55 PM
NCT ID:
NCT07117968
Eligibility Criteria:
Inclusion Criteria:
* Adult patients (aged 18 or over) eligible for a cochlear implant in primary implantation according to French National Authority for Health indications
* Patients suffering from severe to profound bilateral deafness with discrimination less than or equal to 50% on voice audiometry tests using the Fournier list (or equivalent).
* Patients affiliated to the public health insurance body
* Patients who benefit from a Cochlear® system with a processor compatible with Remote Care tools
* Patients using a smartphone compatible with the Nucleus Smart application.
* Patients who have given their written informed consent to the study
* French-speaking patients
Exclusion Criteria:
* Patients already implanted and candidates for implantation of the other ear (bilateralization), or previously implanted (re-implantation).
* Patients with concomitant illnesses that are incompatible with the use of remote monitoring,
* Pregnant women
* Patients suffering from unilateral deafness with incapacitating tinnitus
* Persons under legal protection (guardianship, curators).
* Subjects taking part in other interventional research with an exclusion period still in progress at the time of inclusion.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07117968
Study Brief:
Protocol Section:
NCT07117968