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| Name | Class |
|---|---|
| University of Iowa | OTHER |
| NYU Langone Health | OTHER |
| Midwest Ear Institute | OTHER |
| University of Cincinnati |
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This post approval study evaluates the long term safety and efficacy of the Nucleus Hybrid L24 Implant System in a group of already implanted recipients.
The Hybrid L24 Implant System (P130016) was the subject of a pivotal clinical trial (IDE G070191) from 2007 through 2012. Data on the 50 subjects enrolled in the study, in support of safety and efficacy of the device, was submitted in June 2013 as part of Premarket Approval (PMA) #130016. As a condition of approval, March 20, 2014, a Post-Approval Study was designed to monitor the long-term (5 years postactivation for each subject) safety and effectiveness of the device in this existing cohort of implanted subjects was designed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hybrid L24 pivotal study subjects | Experimental | Subjects implanted with the Nucleus Hybrid L24 Implant as part of the pivotal IDE study and who still have the device implanted will continue to be followed for 5 years post activation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nucleus Hybrid L24 Implant | Device | Subjects have already been implanted with the Nucleus Hybrid L24 implant. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Consonant-Nucleus-Consonant (CNC) Word Recognition in Quiet: Percentage of Total Words Correctly Recognized. | The CNC Words test consists of 10 recorded lists of 50 monosyllabic words in compact disk format. For this study, two lists were administered in quiet at a level equal to 60 dBA (decibels A-weighted) in the sound field and scored as total number of words correct, which will be expressed as a percentage correct. Minimum score is 0/100 words or 0% (worse), maximum score is 100/100 or 100% (best possible). | 5 years postactivation. |
| AzBio (Arizona Biomedical Institute) Sentence Recognition in Noise: Percentage of Total Words Correctly Recognized. | 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. Minimum score is 0 out the total number of words in a given list (varies list to list, with an average length of 141 words) words or 0% (worse), maximum score is all words correctly repeated or 100% (best possible). | 5 years postactivation. |
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Inclusion Criteria:
- Recipients who were implanted with the Hybrid L24 as part of the original pivotal IDE study
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruce J Gantz, MD | University of Iowa | Principal Investigator |
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| 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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Of 53 subjects implanted prior to this study: 6 no longer used the Hybrid L24 implant, 8 subjects were not available to enroll, and 4 subjects declined participation.
Thirty-five subjects enrolled in this postapproval study. First subject enrolled January 14, 2015; last subject enrolled September 12, 2016.
Eight of 10 pivotal study sites agreed to participate.
All subjects who remained enrolled under the pivotal Investigational Device Exemption (IDE) study (G070191) or under a continued access study (G070191/S024) were eligible to participate in this post-approval study.
Subject enrollment for this study was completed in the period, January 14, 2015 through September 12, 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | Hybrid L24 Pivotal Study Subjects. | Available subjects implanted under the pivotal IDE study (G070191) or under a continued access study (G070191/S024) were followed for 5 years postactivation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Hybrid L24 Pivotal Study Subjects. | Available subjects implanted under the pivotal IDE study (G070191) or under a continued access study (G070191/S024) were followed for 5 years postactivation. |
| 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 | Consonant-Nucleus-Consonant (CNC) Word Recognition in Quiet: Percentage of Total Words Correctly Recognized. | The CNC Words test consists of 10 recorded lists of 50 monosyllabic words in compact disk format. For this study, two lists were administered in quiet at a level equal to 60 dBA (decibels A-weighted) in the sound field and scored as total number of words correct, which will be expressed as a percentage correct. Minimum score is 0/100 words or 0% (worse), maximum score is 100/100 or 100% (best possible). | All subjects completing the 5-year postactivation evaluation interval. | Posted | Mean | Standard Deviation | percentage of total words correct | 5 years postactivation. |
|
Adverse event (AE) data were captured from baseline for this study through 5 years postactivation. Since subjects were recruited following their completion of the pivotal study baseline was anywhere from 2 years through 5 years 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 | Hybrid L24 Pivotal Study Subjects. | Available subjects implanted under the pivotal IDE study (G070191) or under a continued access study (G070191/S024) were followed for 5 years postactivation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heart Attack | Cardiac disorders | Systematic Assessment | Subject reported to have had a heart attack prior to the 5-year postactivation evaluation. Subject was hospitalized to have stents placed, hence the adverse event (AE) was deemed serious. This AE was unrelated to the study device. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Teeth cracking and pain associated with Bruxism | General disorders | Systematic Assessment | At study baseline, subject reported teeth cracking associated with pre-existing condition, bruxism (clenching of the teeth/jaw during sleep). Related to a pre-existing condition and not procedure/device related. |
The non-study group presents a potential bias because it was comprised of a number who experienced significant changes in low-frequency acoustic hearing during the pivotal study and their outcomes beyond the pivotal study were not followed. Prior to the beginning of the post-approval study, 13 of the 18 subjects experienced profound/total loss of hearing between surgery and 18 months postactivation, compared with 9 of the 35 subjects who proceeded into the post-approval study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aaron J Parkinson, PhD, Principal Clinical Project Manager | Cochlear Americas | 3035242563 | aparkinson@cochlear.com |
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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 | Sep 9, 2014 | Mar 24, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 17, 2014 | Mar 24, 2021 | SAP_001.pdf |
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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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| OTHER |
| The Center for Hearing and Balance Disorders | AMBIG |
| Ohio State University | OTHER |
| Mayo Clinic | OTHER |
| Hearts for Hearing | OTHER |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| 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 |
|
| Region of Enrollment | Number | participants |
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| Aided Speech Recognition | Aided speech perception refers to the percentage of total words correctly recognized for the speech material presented from a loudspeaker, with the subjects using amplification (i.e., hearing aids). | Mean | Standard Deviation | Percentage of total words correctly re |
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| Primary | AzBio (Arizona Biomedical Institute) Sentence Recognition in Noise: Percentage of Total Words Correctly Recognized. | 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. Minimum score is 0 out the total number of words in a given list (varies list to list, with an average length of 141 words) words or 0% (worse), maximum score is all words correctly repeated or 100% (best possible). | All subjects completing the 5-year postactivation evaluation interval. | Posted | Mean | Standard Deviation | percentage of total words correct | 5 years postactivation. |
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| Post-Hoc | Speech, Spatial and Qualities of Hearing Scale (SSQ): Speech Hearing Subscale | The Speech, Spatial, and Qualities of Hearing Scale or SSQ (Gatehouse & Noble, 2004) was administered as a self-assessment of hearing (dis)abilities across a range of listening situations that fall within three hearing domains: Speech Hearing, Spatial Hearing, and Qualities of Hearing. Within each domain or subscale, each question is scored by the reader indicating on a line marked from 0 through 10. The score for each subscale represents the average of the responses made to each question within the subscale. A score of zero is the minimum and corresponds to minimal ability (i.e., poorer) and 10 corresponds to complete ability (i.e., better) for each subscale. | All subjects completing the 5-year postactivation evaluation interval. | Posted | Mean | Standard Deviation | score on a scale | Preoperative through 5 years postactivation. |
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| Post-Hoc | Speech, Spatial and Qualities of Hearing Scale: Spatial Hearing Subscale | The Speech, Spatial, and Qualities of Hearing Scale or SSQ (Gatehouse & Noble, 2004) was administered as a self-assessment of hearing (dis)abilities across a range of listening situations that fall within three hearing domains: Speech Hearing, Spatial Hearing, and Qualities of Hearing. Within each domain or subscale, each question is scored by the reader indicating on a line marked from 0 through 10. The score for each subscale represents the average of the responses made to each question within the subscale. A score of zero is the minimum and corresponds to minimal ability (i.e., poorer) and 10 corresponds to complete ability (i.e., better) for each subscale. | All subjects completing the 5-year postactivation evaluation interval. | Posted | Mean | Standard Deviation | score on a scale | Preoperative through 5 years postactivation. |
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|
| Post-Hoc | Speech, Spatial and Qualities of Hearing Scale: Qualities of Hearing Subscale | The Speech, Spatial, and Qualities of Hearing Scale or SSQ (Gatehouse & Noble, 2004) was administered as a self-assessment of hearing (dis)abilities across a range of listening situations that fall within three hearing domains: Speech Hearing, Spatial Hearing, and Qualities of Hearing. Within each domain or subscale, each question is scored by the reader indicating on a line marked from 0 through 10. The score for each subscale represents the average of the responses made to each question within the subscale. A score of zero is the minimum and corresponds to minimal ability (i.e., poorer) and 10 corresponds to complete ability (i.e., better) for each subscale. | All subjects completing the 5-year postactivation evaluation interval. | Posted | Mean | Standard Deviation | score on a scale | Preoperative through 5 years postactivation. |
|
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|
| 0 |
| 35 |
| 3 |
| 35 |
| 4 |
| 35 |
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| Cochlear implant revision | Ear and labyrinth disorders | Systematic Assessment | Subject experienced a change in hearing and elected to have the Hybrid L replaced with a traditional cochlear implant 8 years after receiving the Hybrid implant. |
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| Cochlear implant revision | Ear and labyrinth disorders | Systematic Assessment | Subject had revision surgery to replace a contralateral Hybrid L implant, placed after Hybrid approval, associated with loss of residual hearing. Not related to the study device or procedure since it involved the non-study ear. |
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| Ear pain | Ear and labyrinth disorders | Systematic Assessment | Subject reported soreness under the external processor coil during a routine follow-up visit. Resolved with lower magnet setting. |
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| Tinnitus | Ear and labyrinth disorders | Systematic Assessment | After 6 years of device use, subject reported new low-frequency pulsatile tinnitus that occurred intermittently for a few hours daily in the implanted ear. Not device or procedure related as tinnitus present without device use. |
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| Ear pain | Ear and labyrinth disorders | Systematic Assessment | During final study visit, subject reported a sore and pain on top of pinna. Resolved with use of moleskin on ear hook. |
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| Perceived change in hearing due to wax occlusion | Ear and labyrinth disorders | Systematic Assessment | Wax occlusion resulting perceived decreased hearing in right (contralateral) ear, and feeling of water in ear. Resolved following removal of wax. Not related to study ear. |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| <0.001 |
The threshold for statistical significance was p = 0.05. |
| Superiority |
A Friedman repeated-measures ANOVA on ranks was applied to the bilateral AzBio data with follow-up pairwise comparisons based on the Tukey Test. |
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