A Feasibility Study Evaluating the Performance of Focused Multipolar Stimulation in Adult Cochlear Implant Recipients

Launched by COCHLEAR · Aug 5, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at a new way of helping people with hearing impairments who have received a cochlear implant. Researchers want to see if a method called "Focused Multipolar Stimulation" can improve hearing performance, compared to the standard method known as Monopolar stimulation. They will measure how well participants understand speech, enjoy music, and experience daily listening situations, as well as how these changes might affect their overall quality of life.

To participate, adults aged 18 and older who are planning to get a cochlear implant may be eligible, provided they meet certain criteria. For instance, they should primarily speak English and be able to give their written consent. However, some individuals may not qualify, such as those who already have a cochlear implant or have had significant hearing loss from a young age. Participants can expect to take part in various assessments related to their hearing, and the study is currently recruiting participants. It's a chance to contribute to research that could improve hearing technology and outcomes for others in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adults 18 years of age or older.
• • 2. Candidate for unilateral cochlear implant with Slim Modiolar electrode array as determined by the implanting centre.
• • 3. English spoken as a primary language.
• • 4. Willingness to comply with all investigational requirements.
• • 5. Willing and able to provide written informed consent.
• Exclusion Criteria:
• • 1. Previous or existing cochlear-implant recipient.
• • 2. Evidence of severe or greater sensorineural hearing loss prior to five years of age.
• • 3. Open-set pre-operative word score \> 70% in the contralateral ear.
• • 4. Duration of severe to profound hearing loss \> 20 years in the ear to be implanted.
• • 5. Adults with functional acoustic hearing in the ear to be implanted who desire to use an acoustic component in the implanted ear.
• • 6. Ossification or other cochlear anomaly that might prevent complete insertion of the electrode array.
• • 7. Hearing loss of neural or central origin.
• • 8. Medical or psychological conditions that would contraindicate undergoing surgery.
• • 9. Women who are pregnant.
• • 10. Additional handicaps that would prevent or restrict participation in the audiological evaluations.
• • 11. 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.
• • 12. Inability or unwillingness to use a hand-held device to control the sound processor and to collect test and survey data.
• • 13. Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
• • 14. Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
• • 15. Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.
• • 16. Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.