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Clinical Investigation of the Nucleus® CI532 Cochlear Implant

Primary Purpose

Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Nucleus CI532 cochlear implant
Sponsored by
Cochlear
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The HEARing CRC
  • Service d' ORL et d'Otoneurochirurgie, CHU Toulouse Purpan
  • Ear, Nose and Throat Department, University of Freiburg
  • Ear, Nose and Throat Department, Universitätsklinikum Erlangen
  • Klinikum der J. W. Goethe-Universität Frankfurt
  • Ear, Nose and Throat Department, Medizinische Hochschule
  • Universitätsklinikum Schleswig-Holstein - Campus Kiel
  • Complejo Hospitalario Universitario Insular Materno Infantil

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nucleus CI532 cochlear implant

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Array Proximity to the Modiolus Measured Using the Wrapping Factor
The ratio of the active array length and the corresponding lateral wall length
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.
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
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.
Change From Baseline in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire at 6 Months
Rating scale. 0=worst; 10=best
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.
Number of Adverse Events at Surgery
Number of Adverse Events Post Surgery to 6 Months Post-activation

Full Information

First Posted
March 13, 2015
Last Updated
February 26, 2018
Sponsor
Cochlear
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1. Study Identification

Unique Protocol Identification Number
NCT02392403
Brief Title
Clinical Investigation of the Nucleus® CI532 Cochlear Implant
Official Title
Clinical Investigation of the Nucleus® CI532 Cochlear Implant
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cochlear

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nucleus CI532 cochlear implant
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Nucleus CI532 cochlear implant
Primary Outcome Measure Information:
Title
Scalar Position of Electrode Array Determined With Computer Tomography (CT) Scan
Description
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
Secondary Outcome Measure Information:
Title
Array Proximity to the Modiolus Measured Using the Wrapping Factor
Description
The ratio of the active array length and the corresponding lateral wall length
Time Frame
up to one month post-surgery
Title
Surgeon Questionnaire on Implant Surgery
Description
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
Title
Change From Baseline in Speech Recognition in Quiet and Noise at 6 Months
Description
Change in percent correct speech recognition test scores for implant ear alone and best aided
Time Frame
baseline and 6 months post activation
Title
Patient Reported Benefit in Health Status Assessed Via Glasgow Benefit Inventory Questionnaire
Description
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
Title
Change From Baseline in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire at 6 Months
Description
Rating scale. 0=worst; 10=best
Time Frame
baseline and 6 months post activation
Title
Change From Baseline in Air-conduction Pure-tone Hearing Thresholds Via an Audiogram at 6 Months
Description
We report only the change for the 500 Hz frequency.
Time Frame
baseline and 6 months post activation
Title
Number of Adverse Events at Surgery
Time Frame
at time of surgery
Title
Number of Adverse Events Post Surgery to 6 Months Post-activation
Time Frame
post surgery to 6 months post-activation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris J James, PhD
Organizational Affiliation
Cochlear
Official's Role
Study Director
Facility Information:
Facility Name
The HEARing CRC
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3010
Country
Australia
Facility Name
Service d' ORL et d'Otoneurochirurgie, CHU Toulouse Purpan
City
Toulouse
State/Province
Midi-Pyrénées
ZIP/Postal Code
31059
Country
France
Facility Name
Ear, Nose and Throat Department, University of Freiburg
City
Freiburg
State/Province
Baden-Württemberg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Ear, Nose and Throat Department, Universitätsklinikum Erlangen
City
Erlangen
State/Province
Bavaria
ZIP/Postal Code
91054
Country
Germany
Facility Name
Klinikum der J. W. Goethe-Universität Frankfurt
City
Frankfurt am Main
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Facility Name
Ear, Nose and Throat Department, Medizinische Hochschule
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein - Campus Kiel
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Facility Name
Complejo Hospitalario Universitario Insular Materno Infantil
City
Las Palmas
State/Province
Gran Canaria
ZIP/Postal Code
35016
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
30465637
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.
Results Reference
derived

Learn more about this trial

Clinical Investigation of the Nucleus® CI532 Cochlear Implant

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