Prospective within-subject exploratory study of intra-operative and post-operative NRT recordings using varying parameters in Nucleus® Nexa™ cochlear implant recipients
Evaluate ECAP recordings obtained using different NRT recording parameter configurations for participants already implanted with a Nexa cochlear implant or candidates for this implant.
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 parameter settings in the COM software. In this study, COM is used during surgery and in clinic visits to support objective assessment of impedances, Trans Impedance Matrix (TIM), and NRT responses in Cochlear implant users and to provide a reference standard for evaluating the quality of ECAP recordings obtained during the investigation. The study includes randomisation of different parameter settings to be used. Participants will be assigned to their randomisation order based on the sequence of inclusion. Randomisation will follow a predefined randomisation schedule generated prior to study start. The schedule will be produced using a validated computer-based method to ensure allocation concealment and to minimise selection bias.
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
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)