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The purpose of this study is to evaluate the safety and efficacy associated with the provision of acoustic and electric sound processing to individuals who demonstrate significant residual low-frequency hearing and profound high-frequency (above 1500 Hz) sensorineural hearing loss. Delivery of acoustic-electric stimulation will be provided by the Nucleus Hybrid L24 cochlear implant system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgery | Experimental | Implantation with the Nucleus Hybrid L24 Cochlear Implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nucleus Hybrid L24 | Device | Implantation with Nucleus Hybrid L24 cochlear implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Consonant Nucleus Consonant (CNC) Monosyllabic Word Score-Treated Ear (CO-PRIMARY) | The co-primary study endpoints will be statistically significant differences between the mean, preoperative monosyllabic CNC word score (unilateral acoustic, ear to be implanted) and the postoperative monosyllabic CNC word scores (Hybrid mode) for the activated, Hybrid L24 cochlear implant subjects. 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 scored as a total number of words correct, which will be expressed as a percentage correct for this study. | 6 Months Postactivation |
| AzBio Sentence Score in Noise - Treated Ear (Co-Primary) | The co-primary study endpoints will be statistically significant differences between the mean, preoperative AzBio Sentences score in noise (unilateral acoustic, ear to be implanted) and postoperative AzBio Sentences score in noise (Hybrid mode) for the activated, Hybrid L24 cochlear implant subjects. The AzBio Sentence Test 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 towards the overall score. | 6 Months Postactivation |
| Measure | Description | Time Frame |
|---|---|---|
| Consonant Nucleus Consonant (CNC) Monosyllabic Words - Treated Ear | Secondary efficacy endpoints using binomial comparisons (based on the postoperative Hybrid condition) are as follows: 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. The percentage of subjects that scored equal to or better than they did in the pre-operative unilateral acoustic-only condition will be reported. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John T Roland, MD | NYU MEDICAL CENTER | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Medical Center | New York | New York | 10016 | United States |
| 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. | |
| 29330858 | Derived | Roland JT Jr, Gantz BJ, Waltzman SB, Parkinson AJ. Long-term outcomes of cochlear implantation in patients with high-frequency hearing loss. Laryngoscope. 2018 Aug;128(8):1939-1945. doi: 10.1002/lary.27073. Epub 2018 Jan 13. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 6 Months Post Activation | Subjects implanted with the Hybrid L implant who completed the primary endpoint of 6 months postactivation |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Surgery | Implantation with the Nucleus Hybrid L24 Cochlear Implant |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Consonant Nucleus Consonant (CNC) Monosyllabic Word Score-Treated Ear (CO-PRIMARY) | The co-primary study endpoints will be statistically significant differences between the mean, preoperative monosyllabic CNC word score (unilateral acoustic, ear to be implanted) and the postoperative monosyllabic CNC word scores (Hybrid mode) for the activated, Hybrid L24 cochlear implant subjects. 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 scored as a total number of words correct, which will be expressed as a percentage correct for this study. | Posted | Mean | Standard Deviation | percentage of words correct | 6 Months Postactivation |
|
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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 | Surgery | Implantation with the Nucleus Hybrid L24 Cochlear Implant |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hearing loss | Ear and labyrinth disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ginger Grant/Clinical Project Manager | Cochlear Americas | 410-375-0883 | ggrant@cochlear.com |
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| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| 6 Months Postactivation |
| AzBio Sentence Score-Treated Ear | Secondary efficacy endpoints using binomial comparisons (based on the postoperative Hybrid condition) are as follows: The AzBio Sentence Test 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. The percentage of subjects that scored equal to or better than they did in the pre-operative acoustic only condition will be reported. | 6 Months Postactivation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Duration of hearing loss | Mean | Standard Deviation | years |
|
| Duration of severe to profound high frequency hearing loss | Mean | Standard Deviation | years |
|
| Monosyllabic words | The 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 scored as a total number of words correct, which will be expressed as a percentage correct for this study. | Mean | Standard Deviation | percent correct |
|
| AzBio sentences | The AzBio Sentence Test 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 towards the overall score. | Mean | Standard Deviation | percent correct |
|
|
|
| Primary | AzBio Sentence Score in Noise - Treated Ear (Co-Primary) | The co-primary study endpoints will be statistically significant differences between the mean, preoperative AzBio Sentences score in noise (unilateral acoustic, ear to be implanted) and postoperative AzBio Sentences score in noise (Hybrid mode) for the activated, Hybrid L24 cochlear implant subjects. The AzBio Sentence Test 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 towards the overall score. | Posted | Mean | Standard Deviation | percentage of words correct | 6 Months Postactivation |
|
|
|
| Secondary | Consonant Nucleus Consonant (CNC) Monosyllabic Words - Treated Ear | Secondary efficacy endpoints using binomial comparisons (based on the postoperative Hybrid condition) are as follows: 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. The percentage of subjects that scored equal to or better than they did in the pre-operative unilateral acoustic-only condition will be reported. | Posted | Number | percentage of subjects | 6 Months Postactivation |
|
|
|
| Secondary | AzBio Sentence Score-Treated Ear | Secondary efficacy endpoints using binomial comparisons (based on the postoperative Hybrid condition) are as follows: The AzBio Sentence Test 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. The percentage of subjects that scored equal to or better than they did in the pre-operative acoustic only condition will be reported. | Posted | Number | percentage of subjects | 6 Months Postactivation |
|
|
|
| 0 |
| 50 |
| 34 |
| 50 |
| Open/short circuited electrodes | Ear and labyrinth disorders |
|
| Increased Tinnitus | Ear and labyrinth disorders |
|
| Tinnitus not present preoperatively | Ear and labyrinth disorders |
|
| Dizziness | Ear and labyrinth disorders |
|
| Dizziness with change in hearing | Ear and labyrinth disorders |
|
| Increased tinnitus with change in hearing | Ear and labyrinth disorders |
|
| Skin irritation due to externals | Ear and labyrinth disorders |
|
| Sound quality issue | Ear and labyrinth disorders |
|
| Decrease in performance | Ear and labyrinth disorders |
|
| Imbalance | Ear and labyrinth disorders |
|
| Imbalance with change in hearing | Ear and labyrinth disorders |
|
| Increased impedances with change in hearing | Ear and labyrinth disorders |
|
| Local stitch infection | Ear and labyrinth disorders |
|
| Overstimulation | Ear and labyrinth disorders |
|
| Pain in implant ear | Ear and labyrinth disorders |
|
| Vertiginous symptoms with change in hearing | Ear and labyrinth disorders |
|
| Vertigo | Ear and labyrinth disorders |
|
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| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |