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 @ 7:13 PM
Ignite Modification Date:
2025-12-24 @ 7:13 PM
NCT ID:
NCT06894303
Eligibility Criteria:
Inclusion Criteria:
* Ability to provide informed consent
* Ability to give feedback on hearing impressions
* Aged 18 years of age or older
* Implanted with a HiResolution Bionic Ear System (HiRes 90K or HiRes 90K Advantage or HiRes Ultra or HiRes Ultra 3D) on at least one side
* Group 1 - Unilateral: no hearing device except contralateral routing of signals (CROS) device on the contralateral side
* Group 2 - Bilateral: implanted on both sides
* Group 3 - Bimodal: hearing aid on the contralateral side
* Minimum of six months of cochlear implant experience
* Minimum of one month experience with a Naída CI M or Sky CI M sound processor
* Fluent in French language
* Ability to be tested via speech perception test in noise
* Smartphone user
Exclusion Criteria:
* Clinical presentation indicative of potential implanted device malfunction
* Unrealistic expectations regarding potential benefits, risks and limitations of the investigational device as determined by the Investigator
* Unwillingness or inability of subject to comply with all investigational requirements as determined by the Investigator
Pregnancy and breast-feeding are not exclusion criteria.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06894303
Study Brief:
Protocol Section:
NCT06894303