Clinical Investigation of the Nucleus® CI532 Cochlear Implant

Not Applicable

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Nucleus CI532 cochlear implant	Nucleus CI532 cochlear implant	-

Primary Outcome Measures

Name	Time	Method
Scalar Position of Electrode Array Determined With Computer Tomography (CT) Scan	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 Outcome Measures

Name	Time	Method
Array Proximity to the Modiolus Measured Using the Wrapping Factor	up to one month post-surgery	The ratio of the active array length and the corresponding lateral wall length
Surgeon Questionnaire on Implant Surgery	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.
Change From Baseline in Speech Recognition in Quiet and Noise at 6 Months	baseline and 6 months post activation	Change in percent correct speech recognition test scores for implant ear alone and best aided
Patient Reported Benefit in Health Status Assessed Via Glasgow Benefit Inventory Questionnaire	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.
Change From Baseline in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire at 6 Months	baseline and 6 months post activation	Rating scale. 0=worst; 10=best
Number of Adverse Events at Surgery	at time of surgery
Change From Baseline in Air-conduction Pure-tone Hearing Thresholds Via an Audiogram at 6 Months	baseline and 6 months post activation	We report only the change for the 500 Hz frequency.
Number of Adverse Events Post Surgery to 6 Months Post-activation	post surgery to 6 months post-activation

Locations (8): Universitätsklinikum Schleswig-Holstein - Campus Kiel
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Kiel, Schleswig-Holstein, Germany
Ear, Nose and Throat Department, University of Freiburg
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Freiburg, Baden-Württemberg, Germany
Ear, Nose and Throat Department, Universitätsklinikum Erlangen
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Erlangen, Bavaria, Germany
Service d' ORL et d'Otoneurochirurgie, CHU Toulouse Purpan
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Toulouse, Midi-Pyrénées, France
The HEARing CRC
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Melbourne, Victoria, Australia
Ear, Nose and Throat Department, Medizinische Hochschule
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Hannover, Niedersachsen, Germany
Klinikum der J. W. Goethe-Universität Frankfurt
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Frankfurt am Main, Hessen, Germany
Complejo Hospitalario Universitario Insular Materno Infantil
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Las Palmas, Gran Canaria, Spain