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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
The HEARing CRC
Melbourne, Victoria, Australia
Service d' ORL et d'Otoneurochirurgie, CHU Toulouse Purpan
Toulouse, Midi-Pyrénées, France
Ear, Nose and Throat Department, University of Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany
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.
Time frame: up to one month post-surgery
Array Proximity to the Modiolus Measured Using the Wrapping Factor
The ratio of the active array length and the corresponding lateral wall length
Time frame: up to one month post-surgery
Surgeon Questionnaire on Implant 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.
Time frame: at time of surgery
Change From Baseline in Speech Recognition in Quiet and Noise at 6 Months
Change in percent correct speech recognition test scores for implant ear alone and best aided
Time frame: baseline and 6 months post activation
Patient Reported Benefit in Health Status Assessed Via Glasgow Benefit Inventory Questionnaire
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.
Time frame: 6 months post activation
Change From Baseline in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire at 6 Months
Rating scale. 0=worst; 10=best
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Ear, Nose and Throat Department, Universitätsklinikum Erlangen
Erlangen, Bavaria, Germany
Klinikum der J. W. Goethe-Universität Frankfurt
Frankfurt am Main, Hesse, Germany
Ear, Nose and Throat Department, Medizinische Hochschule
Hanover, Lower Saxony, Germany
Universitätsklinikum Schleswig-Holstein - Campus Kiel
Kiel, Schleswig-Holstein, Germany
Complejo Hospitalario Universitario Insular Materno Infantil
Las Palmas, Gran Canaria, Spain
Time frame: baseline and 6 months post activation
Change From Baseline in Air-conduction Pure-tone Hearing Thresholds Via an Audiogram at 6 Months
We report only the change for the 500 Hz frequency.
Time frame: baseline and 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