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 @ 7:46 PM
Ignite Modification Date:
2025-12-24 @ 7:46 PM
NCT ID:
NCT02392403
Eligibility Criteria:
Inclusion Criteria:
* Eighteen years of age or older at the time of implantation
* Conventional candidate for cochlear implantation with a perimodiolar electrode array according to local criteria (excepting the exclusion criteria that follow)
* Native speaker in the local language used to assess clinical performance
Exclusion Criteria:
* Evidence of hearing loss prior to 5 years of age
* Prior cochlear implantation; i.e. having a cochlear implant in the contralateral ear, or previously implanted in either ear
* Medical or psychological conditions that contraindicate undergoing general anaesthesia or surgery
* Ossification, malformation or any other cochlear anomaly, such as common cavity, that might prevent complete insertion of the electrode array, as confirmed by medical examination
* Hearing impairment due to lesion or neuropathy of the acoustic nerve, VIII nerve or central auditory pathway
* Active middle-ear infection
* Tympanic membrane perforation
* Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices
* Unwillingness or inability of the candidate to comply with all investigational requirements such as undergoing a post-operative digital volume tomography/ConeBeam scan
* Patients with existing Cerebral Spinal Fluid shunts or drains, existing perilymph fistula, skull fracture or Cerebral Spinal Fluid leak
* Patients with recurrent episodes of bacterial meningitis
* Pregnancy or breast-feeding
* Known allergies to components of the implant
* Wearing other active implants with known interference with cochlear implants
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02392403
Study Brief:
Protocol Section:
NCT02392403