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 @ 11:44 PM
Ignite Modification Date:
2025-12-24 @ 11:44 PM
NCT ID:
NCT05067751
Eligibility Criteria:
Inclusion Criteria:
Subjects must meet the inclusion criteria described below to be eligible for this clinical investigation.
1. Adults who are English speaking and aged 18 years and older.
2. Individuals with a mild sloping to severe/profound hearing loss in the hearing aided ear.
3. New and experienced bimodal users (cochlear implant + hearing aid).
4. Experienced Nucleus 7 or Kanso 2 cochlear implant users with minimum experience using electrical hearing for 6 months.
5. Individuals able to complete test measures as outlined in the informed consent and protocol.
6. Individuals with access to a Smart Phone/device that is either iOS 7.0 or Android 4.0 and later who are willing to utilize their personal Smart Phone/device for participation in the trial.
7. Individuals willing to use their personal email account for participation in the trial.
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Exclusion Criteria:
Subjects who meet any of the exclusion criteria described below will not be eligible for this clinical investigation.
1. Individuals using sound processors in the Hybrid mode.
2. Bilateral cochlear implant users.
3. Unable or unwilling to comply with the requirements of the study as determined by the Investigator.
4. Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
5. Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational device.
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Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05067751
Study Brief:
Protocol Section:
NCT05067751