The Performance of Different Sound Paths in Adult NeuroZti CI-users
Launched by COCHLEAR · Jun 13, 2025
Trial Information
Current as of July 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at how well two different sound processing methods work for adults who use the NeuroZti cochlear implant, a device that helps people with hearing loss hear better. The study compares the current Neuro 2 sound processor with a newer Nuc8 sound processor, which is being developed to work with the Neuro system but also connect with Cochlear’s newer technology. Researchers want to find out which sound path helps users understand speech better and feels more comfortable and satisfying to use.
To join the study, participants need to be adults between 18 and 75 years old who became deaf after learning to speak and have the NeuroZti cochlear implant in one or both ears. They should be fluent in French and able to follow the study steps. During a single visit of about three hours, participants will take tests to see how well they understand speech in quiet settings and will share their opinions about comfort and overall satisfaction with each sound processor. This study is important because it will help improve support and options for people using these cochlear implants in the future.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Aged 18-75 years old at time of consent.
- • 2. Post-lingually deafened.
- • 3. Bilaterally or unilaterally implanted with Oticon Medical Neuro ZTI cochlear implant, using Crystalis with autoXDP (GMCI 'CAP') as the main program, at 500pps stimulation rate. For bilateral CI users, only first-implanted side will be tested.
- • 4. Fluent in French as determined by the investigator.
- • 5. Willing to participate and comply with requirements of the protocol
- • 6. Willing and able to provide written informed consent.
- Exclusion Criteria:
- • 1. Additional health complexities that would prevent or restrict participation in the evaluations, including significant visual impairment and/or cognitive impairment.
- • 2. Subjects who have life sustaining devices (such as pacemakers).
- • 3. NeuroZti Subjects with Antenna SD Type.
- • 4. Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
- • 5. Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
- • 6. Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this investigation.
- • 7. Pregnant or breastfeeding women.
- • 8. 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).
About Cochlear
Cochlear Limited is a global leader in implantable hearing solutions, dedicated to transforming the lives of individuals with hearing loss through innovative technology and comprehensive clinical research. With a strong commitment to advancing auditory rehabilitation, Cochlear conducts rigorous clinical trials aimed at evaluating the safety and efficacy of its products, including cochlear implants and bone conduction devices. The company collaborates with healthcare professionals and research institutions worldwide to ensure that its solutions meet the highest standards of quality and performance, ultimately enhancing patient outcomes and promoting accessibility to hearing health care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Vallauris, , France
Patients applied
Trial Officials
Chadlia Karoui
Study Director
Cochlear Limited
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported