Clinical trial NCT02392403: Clinical Investigation of the Nucleus® CI532 Cochlear Implant
Official title: Clinical Investigation of the Nucleus® CI532 Cochlear Implant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
First posted: 2015-03-19
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Scalar Position of Electrode Array Determined With Computer Tomography (CT) Scan
timeFrame: up to one month post-surgery
Secondary outcomes:
measure: Array Proximity to the Modiolus Measured Using the Wrapping Factor
timeFrame: up to one month post-surgery
measure: Surgeon Questionnaire on Implant Surgery
timeFrame: at time of surgery
measure: Change From Baseline in Speech Recognition in Quiet and Noise at 6 Months
timeFrame: baseline and 6 months post activation
measure: Patient Reported Benefit in Health Status Assessed Via Glasgow Benefit Inventory Questionnaire
timeFrame: 6 months post activation
measure: Change From Baseline in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire at 6 Months
timeFrame: baseline and 6 months post activation
measure: Change From Baseline in Air-conduction Pure-tone Hearing Thresholds Via an Audiogram at 6 Months
timeFrame: baseline and 6 months post activation
measure: Number of Adverse Events at Surgery
timeFrame: at time of surgery
measure: Number of Adverse Events Post Surgery to 6 Months Post-activation
timeFrame: post surgery to 6 months post-activation
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: The HEARing CRC
state: Victoria
city: Toulouse
country: France
facility: Service d' ORL et d'Otoneurochirurgie, CHU Toulouse Purpan
state: Midi-Pyrénées
city: Freiburg
country: Germany
facility: Ear, Nose and Throat Department, University of Freiburg
state: Baden-Württemberg
city: Erlangen
country: Germany
facility: Ear, Nose and Throat Department, Universitätsklinikum Erlangen
state: Bavaria
city: Frankfurt am Main
country: Germany
facility: Klinikum der J. W. Goethe-Universität Frankfurt
state: Hessen
city: Hannover
country: Germany
facility: Ear, Nose and Throat Department, Medizinische Hochschule
state: Niedersachsen
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein - Campus Kiel
state: Schleswig-Holstein
city: Las Palmas
country: Spain
facility: Complejo Hospitalario Universitario Insular Materno Infantil
state: Gran Canaria
Study officials:
affiliation: Cochlear
name: Chris J James, PhD
role: STUDY_DIRECTOR
References:
citation: 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.