N/A
Completed N=45
Clinical Investigation of the Nucleus® CI532 Cochlear Implant
Source: ClinicalTrials.gov NCT02392403 ↗Enrolled (actual)
45
Serious AEs
8.9%
Results posted
Nov 2018
Primary outcomePrimary: Scalar Position of Electrode Array Determined With Computer Tomography (CT) Scan — 44; 0 Participants
Summary
The aim of this study is to investigate the clinical benefit for patients implanted with the Nucleus® CI532 cochlear implant and to demonstrate the atraumatic nature of the electrode design.
Nucleus® CI532 has a pre-curved, perimodiolar array, the EA32, which is introduced into the cochlea through a straightening sheath.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Scalar Position of Electrode Array Determined With Computer Tomography (CT) Scan |
44; 0 | — |
| SECONDARY Array Proximity to the Modiolus Measured Using the Wrapping Factor |
0.62 | — |
| SECONDARY Surgeon Questionnaire on Implant Surgery |
38 | — |
| SECONDARY Change From Baseline in Speech Recognition in Quiet and Noise at 6 Months |
52.500; 29.668; 63.725; 33.690 | — |
| SECONDARY Patient Reported Benefit in Health Status Assessed Via Glasgow Benefit Inventory Questionnaire |
28.1 | — |
| SECONDARY Change From Baseline in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire at 6 Months |
2.22 | — |
| SECONDARY Change From Baseline in Air-conduction Pure-tone Hearing Thresholds Via an Audiogram at 6 Months |
20 | — |
| SECONDARY Number of Adverse Events at Surgery |
3 | — |
| SECONDARY Number of Adverse Events Post Surgery to 6 Months Post-activation |
32 | — |
Eligibility Criteria
Inclusion Criteria
- Eighteen years of age or older at the time of implantation
- Conventional candidate for cochlear implantation with a perimodiolar electrode array according to local criteria (excepting the exclusion criteria that follow)
- Native speaker in the local language used to assess clinical performance
Exclusion Criteria
- Evidence of hearing loss prior to 5 years of age
- Prior cochlear implantation; i.e. having a cochlear implant in the contralateral ear, or previously implanted in either ear
- Medical or psychological conditions that contraindicate undergoing general anaesthesia or surgery
- Ossification, malformation or any other cochlear anomaly, such as common cavity, that might prevent complete insertion of the electrode array, as confirmed by medical examination
- Hearing impairment due to lesion or neuropathy of the acoustic nerve, VIII nerve or central auditory pathway
- Active middle-ear infection
- Tympanic membrane perforation
- Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices
- Unwillingness or inability of the candidate to comply with all investigational requirements such as undergoing a post-operative digital volume tomography/ConeBeam scan
- Patients with existing Cerebral Spinal Fluid shunts or drains, existing perilymph fistula, skull fracture or Cerebral Spinal Fluid leak
- Patients with recurrent episodes of bacterial meningitis
- Pregnancy or breast-feeding
- Known allergies to components of the implant
- Wearing other active implants with known interference with cochlear implants
Data sourced from ClinicalTrials.gov (NCT02392403). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.