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 @ 11:03 PM
Ignite Modification Date:
2025-12-24 @ 11:03 PM
NCT ID:
NCT05402969
Eligibility Criteria:
Inclusion Criteria:
Group with long-term implantation:
* Age18 years or older
* Affiliation to the French social security
* Signed and dated informed consent form
* Users of uni or bilateral cochlear implants for more than 6 months (CI24CA, CI422, CI512, CI522, CI532, CI612; CI622; CI632), in primo-implantation or reimplantation, with more than 18 electrodes active
* Postoperation CBCT imaging results available
Recently-implanted group:
* Age18 years or older
* Affiliation to the French social security
* Signed and dated informed consent form
* Indication for CI622 or CI632 cochlear implants
* Postoperation CBCT imaging results available
Exclusion Criteria:
* Vulnerable individuals (minors, adults protected in accordance to the French Public Health code, patients deprived of liberty by court decision)
* Daily usage of the cochlear implant for less than 4 hours or weekly usage for less than 5 days
* Failure or disfunction of the cochlear implant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT05402969
Study Brief:
Protocol Section:
NCT05402969