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 @ 10:19 PM
Ignite Modification Date:
2025-12-24 @ 10:19 PM
NCT ID:
NCT06642935
Eligibility Criteria:
Inclusion Criteria:
* Aged 18 years or older, at time of consent
* Candidate for cochlear implantation as assessed by the implanting clinic
* Fluent in English, as determined by the investigator
* Willing to participate in and comply with all requirements of the protocol
* Willing and able to provide written informed consent
Exclusion Criteria:
* Severe, or poorer, bilateral sensorineural hearing loss prior to five years of age, as reported by the subject
* Duration of severe to profound hearing loss greater than 20 years in the ear to be implanted as reported by the subject or by audiometric history, if available
* Ossification, otosclerosis, malformation or any other cochlear anomaly, such as common cavity, that might prevent complete insertion of the electrode array
* Deafness due to lesions of the acoustic nerve affecting the ear to be implanted
* Medical or psychological conditions that would contraindicate undergoing anaesthesia, surgery or participation in the clinical investigation, as determined by the investigator
* Additional disabilities that may affect the subject's participation or safety during the clinical investigation, as determined by the investigator
* Unrealistic expectations on the part of the subject regarding the possible benefits, risks and limitations that are inherent to the surgical procedure and prosthetic device, as determined by the investigator
* Desire to use an integrated acoustic component post-implantation
* Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator
* Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling
* Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this investigation.
* Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless Cochlear sponsored and determined by investigator or Sponsor to not impact this investigation)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06642935
Study Brief:
Protocol Section:
NCT06642935