Clinical Investigation of the Nucleus® CI532 Cochlear Implant
1 other identifier
interventional
45
4 countries
8
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2015
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2015
CompletedFirst Posted
Study publicly available on registry
March 19, 2015
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedResults Posted
Study results publicly available
November 1, 2018
CompletedNovember 1, 2018
July 1, 2017
1.3 years
March 13, 2015
July 27, 2017
February 26, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Scalar Position of Electrode Array Determined With Computer Tomography (CT) Scan
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.
up to one month post-surgery
Secondary Outcomes (8)
Array Proximity to the Modiolus Measured Using the Wrapping Factor
up to one month post-surgery
Surgeon Questionnaire on Implant Surgery
at time of surgery
Change From Baseline in Speech Recognition in Quiet and Noise at 6 Months
baseline and 6 months post activation
Patient Reported Benefit in Health Status Assessed Via Glasgow Benefit Inventory Questionnaire
6 months post activation
Change From Baseline in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire at 6 Months
baseline and 6 months post activation
- +3 more secondary outcomes
Study Arms (1)
Nucleus CI532 cochlear implant
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Eighteen years of age or older at the time of implantation
You may not qualify if:
- Native speaker in the local language used to assess clinical performance
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cochlearlead
Study Sites (8)
The HEARing CRC
Melbourne, Victoria, 3010, Australia
Service d' ORL et d'Otoneurochirurgie, CHU Toulouse Purpan
Toulouse, Midi-Pyrénées, 31059, France
Ear, Nose and Throat Department, University of Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
Ear, Nose and Throat Department, Universitätsklinikum Erlangen
Erlangen, Bavaria, 91054, Germany
Klinikum der J. W. Goethe-Universität Frankfurt
Frankfurt am Main, Hesse, 60590, Germany
Ear, Nose and Throat Department, Medizinische Hochschule
Hanover, Lower Saxony, 30625, Germany
Universitätsklinikum Schleswig-Holstein - Campus Kiel
Kiel, Schleswig-Holstein, 24105, Germany
Complejo Hospitalario Universitario Insular Materno Infantil
Las Palmas, Gran Canaria, 35016, Spain
Related Publications (1)
Hey M, Wesarg T, Mewes A, Helbig S, Hornung J, Lenarz T, Briggs R, Marx M, Ramos A, Stover T, Escude B, James CJ, Aschendorff A. Objective, audiological and quality of life measures with the CI532 slim modiolar electrode. Cochlear Implants Int. 2019 Mar;20(2):80-90. doi: 10.1080/14670100.2018.1544684. Epub 2018 Nov 22.
PMID: 30465637DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chris James
- Organization
- Cochlear
Study Officials
- STUDY DIRECTOR
Chris J James, PhD
Cochlear
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2015
First Posted
March 19, 2015
Study Start
April 1, 2015
Primary Completion
July 1, 2016
Study Completion
July 1, 2016
Last Updated
November 1, 2018
Results First Posted
November 1, 2018
Record last verified: 2017-07