Clinical Investigation of the Nucleus® CI532 Cochlear Implant

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02392403
• Date of registration: 13/03/2015
• Prospective Registration: Yes
• Primary sponsor: Cochlear
• Public title: Clinical Investigation of the Nucleus® CI532 Cochlear Implant
• Scientific title: Clinical Investigation of the Nucleus® CI532 Cochlear Implant
• Date of first enrolment: April 2015
• Target sample size: 45
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02392403
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Australia, France, Germany, Spain

Contacts

• Name: Chris J James, PhD
• Affiliation: Cochlear

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hearing Loss

Intervention(s)

Device: Nucleus CI532 cochlear implant

Primary Outcome(s)

Scalar Position of Electrode Array Determined With Computer Tomography (CT) Scan [Time Frame: up to one month post-surgery]

Secondary Outcome(s)

Change From Baseline in Air-conduction Pure-tone Hearing Thresholds Via an Audiogram at 6 Months [Time Frame: baseline and 6 months post activation]

Change From Baseline in Speech Recognition in Quiet and Noise at 6 Months [Time Frame: baseline and 6 months post activation]

Patient Reported Benefit in Health Status Assessed Via Glasgow Benefit Inventory Questionnaire [Time Frame: 6 months post activation]

Number of Adverse Events at Surgery [Time Frame: at time of surgery]

Number of Adverse Events Post Surgery to 6 Months Post-activation [Time Frame: post surgery to 6 months post-activation]

Array Proximity to the Modiolus Measured Using the Wrapping Factor [Time Frame: up to one month post-surgery]

Change From Baseline in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire at 6 Months [Time Frame: baseline and 6 months post activation]

Surgeon Questionnaire on Implant Surgery [Time Frame: at time of surgery]

Secondary ID(s)

CLTD5446

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 01/11/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02392403