Skip to main content
OpenTrials
Completed

NCT Number: NCT02392403

Clinical Investigation of the Nucleus® CI532 Cochlear Implant

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hearing Loss Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The HEARing CRC, Melbourne, Victoria, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nucleus CI532 cochlear implant

Device

Primary outcomes

  1. Scalar Position of Electrode Array Determined With Computer Tomography (CT) Scan

    Time frame: up to one month post-surgery

    The position of the electrode array can be completely in scala tympani, completely in scala vestibuli, or may transverse from scala tympani to scala vestibuli. The position can be determined from high resolution flat panel volume tomography (Cone beam) imaging.

Secondary outcomes

  1. Array Proximity to the Modiolus Measured Using the Wrapping Factor

    Time frame: up to one month post-surgery

    The ratio of the active array length and the corresponding lateral wall length

  2. Surgeon Questionnaire on Implant Surgery

    Time frame: at time of surgery

    To collect experiences using the CI532. At each surgery, the surgeon was asked whether "overall the CI532 was easy to handle and the EA32 easy to insert". We counted the number of surgeons who strongly agreed or who agreed.

  3. Change From Baseline in Speech Recognition in Quiet and Noise at 6 Months

    Time frame: baseline and 6 months post activation

    Change in percent correct speech recognition test scores for implant ear alone and best aided

  4. Patient Reported Benefit in Health Status Assessed Via Glasgow Benefit Inventory Questionnaire

    Time frame: 6 months post activation

    The Glasgow Benefit Inventory is a single time point measure of patient reported benefit.

    A score of 0 indicates no benefit; the minimum score is -100 and the maximum is +100.

  5. Change From Baseline in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire at 6 Months

    Time frame: baseline and 6 months post activation

    Rating scale. 0=worst; 10=best

  6. Change From Baseline in Air-conduction Pure-tone Hearing Thresholds Via an Audiogram at 6 Months

    Time frame: baseline and 6 months post activation

    We report only the change for the 500 Hz frequency.

  7. Number of Adverse Events at Surgery

    Time frame: at time of surgery

  8. Number of Adverse Events Post Surgery to 6 Months Post-activation

    Time frame: post surgery to 6 months post-activation

Sponsors and collaborators

Lead sponsor

Cochlear

Industry

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 19, 2015
Registry last updated
Nov 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.