Hearing Loss
Conditions
Brief summary
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.
Detailed description
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.
Interventions
Subjects have already been implanted with the Nucleus Hybrid L24 implant.
Sponsors
University of Iowa
NYU Langone Health
Midwest Ear Institute
University of Cincinnati
The Center for Hearing and Balance Disorders
Ohio State University
Mayo Clinic
Hearts for Hearing
Cochlear
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Recipients who were implanted with the Hybrid L24 as part of the original pivotal IDE study
Exclusion criteria
* Recipients who withdrew or were terminated from the L24 pivotal IDE study * Recipients who were re-implanted and no longer have a Nucleus Hybrid L24 implant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Consonant-Nucleus-Consonant (CNC) Word Recognition in Quiet: Percentage of Total Words Correctly Recognized. | 5 years postactivation. | 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). |
| AzBio (Arizona Biomedical Institute) Sentence Recognition in Noise: Percentage of Total Words Correctly Recognized. | 5 years postactivation. | 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). |
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 35 |
| Total | 35 |
Baseline characteristics
| Characteristic | Hybrid L24 Pivotal Study Subjects. | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 17 Participants | — |
| Age, Categorical Between 18 and 65 years | 18 Participants | — |
| Age, Continuous | 61.3 years STANDARD_DEVIATION 16.1 | — |
| Aided Speech Recognition AzBio+5 dB SNR Bilateral: Percentage of total words correctly recognized. | 28.8 Percentage of total words correctly re STANDARD_DEVIATION 20.6 | — |
| Aided Speech Recognition AzBio+5 dB SNR Implant Ear: Percentage of total words correctly recognized. | 15.7 Percentage of total words correctly re STANDARD_DEVIATION 13.7 | — |
| Aided Speech Recognition CNC Words Bilateral: Percentage of total words correctly recognized. | 44.4 Percentage of total words correctly re STANDARD_DEVIATION 17.3 | — |
| Aided Speech Recognition CNC Words Contralateral: Percentage of total words correctly recognized. | 39 Percentage of total words correctly re STANDARD_DEVIATION 17.9 | — |
| Aided Speech Recognition CNC Words Implanted Ear: Percentage of total words correctly recognized. | 27 Percentage of total words correctly re STANDARD_DEVIATION 14.6 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 35 participants | — |
| Sex: Female, Male Female | 19 Participants | — |
| Sex: Female, Male Male | 16 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 35 |
| other Total, other adverse events | 4 / 35 |
| serious Total, serious adverse events | 3 / 35 |
Outcome results
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).
Time frame: 5 years postactivation.
Population: All subjects completing the 5-year postactivation evaluation interval.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hybrid L24 Pivotal Study Subjects. | AzBio (Arizona Biomedical Institute) Sentence Recognition in Noise: Percentage of Total Words Correctly Recognized. | Implanted Ear | 49.6 percentage of total words correct | Standard Deviation 27.5 |
| Hybrid L24 Pivotal Study Subjects. | AzBio (Arizona Biomedical Institute) Sentence Recognition in Noise: Percentage of Total Words Correctly Recognized. | Bilateral Condition | 61.4 percentage of total words correct | Standard Deviation 24.5 |
p-value: <0.001ANOVA
p-value: <0.001ANOVA
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).
Time frame: 5 years postactivation.
Population: All subjects completing the 5-year postactivation evaluation interval.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hybrid L24 Pivotal Study Subjects. | Consonant-Nucleus-Consonant (CNC) Word Recognition in Quiet: Percentage of Total Words Correctly Recognized. | Implanted Ear | 71.2 percentage of total words correct | Standard Deviation 20.4 |
| Hybrid L24 Pivotal Study Subjects. | Consonant-Nucleus-Consonant (CNC) Word Recognition in Quiet: Percentage of Total Words Correctly Recognized. | Bilateral Condition | 81 percentage of total words correct | Standard Deviation 12.7 |
Comparison: A Friedman repeated-measures ANOVA on ranks was applied to the unilateral CNC data with follow-up pairwise comparisons based on the Tukey Test.p-value: <0.001ANOVA
p-value: <0.001ANOVA
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.
Time frame: Preoperative through 5 years postactivation.
Population: All subjects completing the 5-year postactivation evaluation interval.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hybrid L24 Pivotal Study Subjects. | Speech, Spatial and Qualities of Hearing Scale: Qualities of Hearing Subscale | Preoperative | 4.8 score on a scale | Standard Deviation 1.5 |
| Hybrid L24 Pivotal Study Subjects. | Speech, Spatial and Qualities of Hearing Scale: Qualities of Hearing Subscale | 1 Year Postactivation | 6.7 score on a scale | Standard Deviation 1.7 |
| Hybrid L24 Pivotal Study Subjects. | Speech, Spatial and Qualities of Hearing Scale: Qualities of Hearing Subscale | 5 Years Postactivation | 6.4 score on a scale | Standard Deviation 1.4 |
p-value: <0.001ANOVA
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.
Time frame: Preoperative through 5 years postactivation.
Population: All subjects completing the 5-year postactivation evaluation interval.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hybrid L24 Pivotal Study Subjects. | Speech, Spatial and Qualities of Hearing Scale: Spatial Hearing Subscale | Preoperative | 4.2 score on a scale | Standard Deviation 1.8 |
| Hybrid L24 Pivotal Study Subjects. | Speech, Spatial and Qualities of Hearing Scale: Spatial Hearing Subscale | 1 Year Postactivation | 5.6 score on a scale | Standard Deviation 2 |
| Hybrid L24 Pivotal Study Subjects. | Speech, Spatial and Qualities of Hearing Scale: Spatial Hearing Subscale | 5 Years Postactivation | 5.01 score on a scale | Standard Deviation 1.7 |
p-value: <0.001ANOVA
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.
Time frame: Preoperative through 5 years postactivation.
Population: All subjects completing the 5-year postactivation evaluation interval.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hybrid L24 Pivotal Study Subjects. | Speech, Spatial and Qualities of Hearing Scale (SSQ): Speech Hearing Subscale | Preoperative | 3.3 score on a scale | Standard Deviation 1.4 |
| Hybrid L24 Pivotal Study Subjects. | Speech, Spatial and Qualities of Hearing Scale (SSQ): Speech Hearing Subscale | 1 Year Postactivation | 5.9 score on a scale | Standard Deviation 1.7 |
| Hybrid L24 Pivotal Study Subjects. | Speech, Spatial and Qualities of Hearing Scale (SSQ): Speech Hearing Subscale | 5 Years Postactivation | 5.4 score on a scale | Standard Deviation 1.6 |
p-value: <0.001ANOVA