A Study to Evaluate Clinical Benefit, Performance and Safety of Cochlear Implants in Adults
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCochlear
About this trial
The aim of this clinical investigation is to demonstrate the performance, clinical benefit and safety of commercial cochlear implant systems. Speech performance and subjective hearing results, and comparison with cochlear implant results available in literature, is intended to demonstrate the performance and clinical benefit of the cochlear implant systems investigated in this study.
Eligibility criteria
Qualifiers
Aged 18 years or older (at time of consent).
Clinically established post-linguistic moderately severe to profound sensorineural hearing loss, in the ear to be implanted.
Compromised functional hearing with hearing aid(s) or unlikely to receive benefit with hearing aid(s) in the ear to be implanted.
Cochlear implant candidate as determined by the Principal Investigator. Meets local candidacy criteria for cochlear implantation.
Disqualifiers
Prior cochlear implantation in the ear to be implanted.
Unrealistic expectations regarding the possible benefit, risks and limitations that are inherent to the surgical procedure and prosthetic device as determined by the investigator.
Any contraindications for cochlear implantation listed in the relevant product physician's guide (to be specified per sub-investigation).
Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
Trial design
Treatments tested in this trial
- Cochlear Nucleus Nexa Cochlear implant (CI1032)
- Cochlear Nucleus Nexa Cochlear implant (CI1022)
- Cochlear Nucleus Nexa Cochlear implant (CI1012)
Treatment groups
66 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov