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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nucleus CI532 cochlear implant | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nucleus CI532 cochlear implant | Device |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chris J James, PhD | Cochlear | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The HEARing CRC | Melbourne | Victoria | 3010 | Australia | ||
| Service d' ORL et d'Otoneurochirurgie, CHU Toulouse Purpan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30465637 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nucleus CI532 Cochlear Implant | Single arm study. All participants received CI532. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nucleus CI532 Cochlear Implant | Single arm study. All participants received CI532. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | One patient was explanted and reimplanted with a different type of device. | Posted | Count of Participants | Participants | up to one month post-surgery |
|
|
16 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nucleus CI532 Cochlear Implant | Single arm study. All participants received CI532. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Prolonged hospitalization for re-implantation | Ear and labyrinth disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tinnitus | Ear and labyrinth disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chris James | Cochlear | +33 534 638 584 | cjames@cochlear.com |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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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 |
| Toulouse |
| Midi-Pyrénées |
| 31059 |
| France |
| Ear, Nose and Throat Department, University of Freiburg | Freiburg im Breisgau | Baden-Wurttemberg | 79106 | Germany |
| Ear, Nose and Throat Department, Universitätsklinikum Erlangen | Erlangen | Bavaria | 91054 | Germany |
| Klinikum der J. W. Goethe-Universität Frankfurt | Frankfurt am Main | Hesse | 60590 | Germany |
| Ear, Nose and Throat Department, Medizinische Hochschule | Hanover | Lower Saxony | 30625 | Germany |
| Universitätsklinikum Schleswig-Holstein - Campus Kiel | Kiel | Schleswig-Holstein | 24105 | Germany |
| Complejo Hospitalario Universitario Insular Materno Infantil | Las Palmas | Gran Canaria | 35016 | Spain |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Array Proximity to the Modiolus Measured Using the Wrapping Factor | The ratio of the active array length and the corresponding lateral wall length | Posted | Mean | Standard Deviation | ratio | up to one month post-surgery |
|
|
|
| Secondary | 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. | Posted | Number | Surgeons | at time of surgery |
|
|
|
| Secondary | 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 | Posted | Median | Inter-Quartile Range | Percent correct | baseline and 6 months post activation |
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 6 months post activation |
|
|
|
| Secondary | Change From Baseline in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire at 6 Months | Rating scale. 0=worst; 10=best | Posted | Mean | 95% Confidence Interval | units on a scale | baseline and 6 months post activation |
|
|
|
| Secondary | 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. | Note that some patients had no measurable pre-operative hearing | Posted | Median | Inter-Quartile Range | Decibels | baseline and 6 months post activation |
|
|
|
| Secondary | Number of Adverse Events at Surgery | Posted | Number | adverse events | at time of surgery |
|
|
|
| Secondary | Number of Adverse Events Post Surgery to 6 Months Post-activation | Posted | Number | adverse events | post surgery to 6 months post-activation |
|
|
|
| 1 |
| 45 |
| 4 |
| 45 |
| 30 |
| 45 |
| Death due to myocardial infarction | Cardiac disorders |
|
| Hospitalization for hysterectomy and bladder wall reinforcement | General disorders |
|
| Pain | General disorders |
|
| Dizziness and/or vertigo | Ear and labyrinth disorders |
|
| Nausea | Gastrointestinal disorders |
|
The investigator agrees to send any Conference presentations/publications to the Sponsor for review at least 30 days prior to publication/presentation and after the first publication has been submitted. The Sponsor has the right to require any confidential information to be removed. If there is intellectual property disclosed, which the Sponsor intends to protect by registration such as by patent application, the Sponsor may require the release of the publication to be delayed by up to 120 days.
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
|
| 10 db Signal-to-Noise Ratio (SNR) Best Aided |
|