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This study evaluates the long term safety and effectiveness of the Nucleus Hybrid L24 Implant in a group of newly implanted adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nucleus Hybrid L24 Implant | Experimental | Adults age 18 and over who meet FDA criteria for unilateral implantation with the Nucleus Hybrid L24 Implant. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nucleus Hybrid L24 Implant | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Consonant-Nucleus-Consonant (CNC) Word Recognition in Quiet for the Two Listening Conditions: Implant Ear Alone and When Using Both Ears Together From Pre-operatively Through 3 Years Post-activation of the Device | The CNC Words test consists of 10 recorded lists of 50 monosyllabic words in CD format. For this study, two lists will be administered in quiet at a level equal to 60 dBA in the sound field and recorded as a total number of words correct, which will be expressed as a percentage correct for this study. The CNC word test has a score range of 0-100% with higher values indicating better scores. | From pre-operatively through 3 years post-activation of the device |
| Number of Device or Procedure Related Adverse Events | Up to 5 years post-activation of the device |
| Measure | Description | Time Frame |
|---|---|---|
| Change in AzBio Sentence Recognition in Noise in the Best Unilateral Condition | The AzBio Sentence Tests consists of 15 lists of 20 sentences each. AzBio sentences are spoken by different talkers in a conversational style with limited contextual cues that the listener can use to predict or 'fill in' unintelligible words. Each list includes 5 sentences from 4 different male and female speakers. Each word in the sentence counts toward the overall score and the resulting score is presented in percent correct. The AzBio sentence test has a score range of 0-100% with higher values indicating better scores. |
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Inclusion Criteria:
Ear to Be Implanted:
Contralateral Ear:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Kaplan, MD | Greater Baltimore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Ear Center | Phoenix | Arizona | 85004 | United States | ||
| Kaiser Permanente South Sacramento |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41059917 | Derived | Reinhart PN, Parkinson AJ, Dunn CC, Gantz BJ. Factors Affecting Audiometric and Speech Perception Outcomes in Hybrid Cochlear Implant Recipients. Laryngoscope. 2026 Mar;136(3):1475-1486. doi: 10.1002/lary.70195. Epub 2025 Oct 8. | |
| 39514431 | Derived | Reinhart P, Parkinson A, Gifford RH. Hybrid Cochlear Implant Outcomes and Improving Outcomes With Electric-Acoustic Stimulation. Otol Neurotol. 2024 Dec 1;45(10):e749-e755. doi: 10.1097/MAO.0000000000004305. |
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Cochlear do not have an approved platform for public sharing of IPD collected in this study. Data may be provided to individual researchers on request.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nucleus Hybrid L24 Implant | Adults age 18 and over who meet FDA criteria for unilateral implantation with the Nucleus Hybrid L24 Implant. Nucleus Hybrid L24 Implant |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 30, 2022 | Feb 7, 2023 |
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| Pre-operatively, up to 3 years post-activation of the device |
| Sacramento |
| California |
| 95823 |
| United States |
| University of Colorado Hospitals | Aurora | Colorado | 80045 | United States |
| Denver Ear Associates | Englewood | Colorado | 80110 | United States |
| Rocky Mountain Ear Center | Englewood | Colorado | 80113 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| NorthShore University Health System | Northbrook | Illinois | 60062 | United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| Greater Baltimore Medical Center | Baltimore | Maryland | 21204 | United States |
| Lahey Hospital and Medical Center | Burlington | Massachusetts | 01803 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Michigan Ear Institute | Farmington Hills | Michigan | 48334 | United States |
| Midwest Ear Institute | Kansas City | Missouri | 64111 | United States |
| The University of Cincinnati | Cincinnati | Ohio | 45219 | United States |
| Ohio Ear Institute | Westerville | Ohio | 43082 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Pittsburgh Ear Associates | Pittsburgh | Pennsylvania | 15212 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Ear Institute of Texas | San Antonio | Texas | 78258 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Nucleus Hybrid L24 Implant | Adults age 18 and over who meet FDA criteria for unilateral implantation with the Nucleus Hybrid L24 Implant. Nucleus Hybrid L24 Implant |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Change in Consonant-Nucleus-Consonant (CNC) Word Recognition in Quiet for the Two Listening Conditions: Implant Ear Alone and When Using Both Ears Together From Pre-operatively Through 3 Years Post-activation of the Device | The CNC Words test consists of 10 recorded lists of 50 monosyllabic words in CD format. For this study, two lists will be administered in quiet at a level equal to 60 dBA in the sound field and recorded as a total number of words correct, which will be expressed as a percentage correct for this study. The CNC word test has a score range of 0-100% with higher values indicating better scores. | Data was not collected for all 52 participants at all of the time points. At 2 years post-activation, one participant doesn't have a bilateral speech score. | Posted | Mean | 95% Confidence Interval | percentage of correct words | From pre-operatively through 3 years post-activation of the device |
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| Primary | Number of Device or Procedure Related Adverse Events | Related AEs were reported up to 3 years with some participants up to 5 years as the protocol was amended from 5 to 3 year follow-up in 2022. The data include all related AEs reported. | Posted | Number | Number of events | Up to 5 years post-activation of the device |
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| Secondary | Change in AzBio Sentence Recognition in Noise in the Best Unilateral Condition | The AzBio Sentence Tests consists of 15 lists of 20 sentences each. AzBio sentences are spoken by different talkers in a conversational style with limited contextual cues that the listener can use to predict or 'fill in' unintelligible words. Each list includes 5 sentences from 4 different male and female speakers. Each word in the sentence counts toward the overall score and the resulting score is presented in percent correct. The AzBio sentence test has a score range of 0-100% with higher values indicating better scores. | Data was not collected for all 52 participants at all of the time points. At 1 year post-activation, one participant completed the testing at +10 dB SNR (decibel signal to noise ratio) instead of +5 dB SNR which is what is reported on. | Posted | Mean | 95% Confidence Interval | percentage of correct words | Pre-operatively, up to 3 years post-activation of the device |
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Up to 5 years
Device and procedure related adverse events are reported. The related AEs were reported up to 3 years with some patients up to 5 years as the protocol was amended from 5 to 3 year follow-up in 2022. Two participants passed away but the cause of death was not related to the device or procedure.
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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 Hybrid L24 Implant | Adults age 18 and over who meet FDA criteria for unilateral implantation with the Nucleus Hybrid L24 Implant. Nucleus Hybrid L24 Implant | 2 | 52 | 1 | 52 | 35 | 52 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Explantation at patient's request due to sound quality | Ear and labyrinth disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Profound hearing loss | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| New or worsened tinnitus | Ear and labyrinth disorders | Non-systematic Assessment |
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| Vertigo/dizziness | Ear and labyrinth disorders | Non-systematic Assessment |
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| Skin irritation due to externals | General disorders | Non-systematic Assessment |
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| Pain in implanted ear | Ear and labyrinth disorders | Non-systematic Assessment |
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| Nausea/vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| Sound quality issue | Product Issues | Non-systematic Assessment |
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| Taste/Tongue disturbance | General disorders | Non-systematic Assessment |
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| Ear numbness | General disorders | Non-systematic Assessment |
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| Small parts hazard | Product Issues | Non-systematic Assessment |
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The aggregate data resulting from this study will be the proprietary information of the Sponsor and may be made public after all data have been analyzed and the study results are available. None of the data resulting from this study will be allowed to be presented or published in any form, by the Investigator or any other person, without the prior written approval of the Sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| PRS Specialist, Clinical Affairs | Cochlear | +61 2 9428 6555 | cltd-prs-admin@cochlear.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 30, 2022 | Feb 7, 2023 | SAP_001.pdf |
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| Unilateral condition at 1 year post-activation |
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| Unilateral condition at 2 years post-activation |
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| Unilateral condition at 3 years post-activation |
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| Bilateral condition at 3 months post-activation |
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| Bilateral condition at 6 months post-activation |
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| Bilateral condition at 1 year post-activation |
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| Bilateral condition at 2 years post-activation |
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| Bilateral condition at 3 years post-activation |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Total number of device or procedure related adverse event |
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| Number of serious device or procedure related adverse event |
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