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.

Study Overview

• Status: Completed
• Conditions: Hearing Loss
• Intervention / Treatment: Device: Nucleus CI532 cochlear implant

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3010
      • The HEARing CRC
• France
  • Midi-Pyrénées
    • Toulouse, Midi-Pyrénées, France, 31059
      • Service d' ORL et d'Otoneurochirurgie, CHU Toulouse Purpan
• Germany
  • Baden-Württemberg
    • Freiburg, Baden-Württemberg, Germany, 79106
      • Ear, Nose and Throat Department, University of Freiburg
  • Bavaria
    • Erlangen, Bavaria, Germany, 91054
      • Ear, Nose and Throat Department, Universitätsklinikum Erlangen
  • Hessen
    • Frankfurt am Main, Hessen, Germany, 60590
      • Klinikum der J. W. Goethe-Universität Frankfurt
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30625
      • Ear, Nose and Throat Department, Medizinische Hochschule
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24105
      • Universitätsklinikum Schleswig-Holstein - Campus Kiel
• Spain
  • Gran Canaria
    • Las Palmas, Gran Canaria, Spain, 35016
      • Complejo Hospitalario Universitario Insular Materno Infantil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nucleus CI532 cochlear implant	Device: Nucleus CI532 cochlear implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Array Proximity to the Modiolus Measured Using the Wrapping Factor	The ratio of the active array length and the corresponding lateral wall length	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.	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	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.	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	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.	baseline and 6 months post activation
Number of Adverse Events at Surgery		at time of surgery
Number of Adverse Events Post Surgery to 6 Months Post-activation		post surgery to 6 months post-activation

Collaborators and Investigators

• Sponsor: Cochlear
• Investigators: Study Director: Chris J James, PhD, Cochlear

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: March 13, 2015
• First Submitted That Met QC Criteria: March 13, 2015
• First Posted (Estimate): March 19, 2015

Study Record Updates

• Last Update Posted (Actual): November 1, 2018
• Last Update Submitted That Met QC Criteria: February 26, 2018
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss
• Other Study ID Numbers: CLTD5446