Evaluate ECAP recordings obtained using different NRT recording parameter configurations for participants already implanted with a Nexa cochlear implant or candidates for this implant. Ear, Nose and Throat
Conditions
Interventions
Adult Nexa™ implant users will undergo one research session accompanying a standard clinic visit or surgery. During this session, ECAP recordings will be performed with different NRT recording paramet
Sponsors
Cochlear
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Implanted with a Nucleus CI1032/CI1022/CI1024/CI1012 or scheduled for Nucleus CI1032/CI1022/CI1024/CI1012 implantation 2. 18 years or older (no upper age limit) 3. Sufficient speaker of Dutch to communicate with the investigator and correctly understand the informed consent form, as judged by the investigator 4. Willing to participate and comply with all requirements of the study protocol 5. Willing and able to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Diagnosis of auditory neuropathy 2. Additional health factors, known to the investigator, that would prevent or limit participation in the study 3. Unable or unwilling to comply with the requirements of the clinical investigation 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. Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for this investigation 6. Pregnant or breastfeeding women, as reported by the participant 7. 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Within-subject repeated measurements of clinical impedances, measured using impedance values before vs. after conditioning, and postoperatively using the COM software at Visit 1 (intraoperative and postoperative);Within-subject repeated measurements of NRT, measured using NRT thresholds before vs. after conditioning, and postoperatively across NRT configurations, using the COM software at Visit 1 (intraoperative and postoperative) | — |
Countries
Belgium
Contacts
Public ContactPRS Specialist
Outcome results
None listed