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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P000025 S084/ PAS001 |
| Date Original Protocol Accepted |
12/08/2016
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| Date Current Protocol Accepted |
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| Study Name |
MED-EL EAS Extended f/u Study
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| Device Name |
MED-EL COCHLEAR IMPLANT SYSTEM
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| Clinical Trial Number(s) |
NCT00747435
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
Device Subjects Serve as Own Control
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| Analysis Type |
Analytical
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| Study Population |
Transit.Adolescent B(as adults): 18 yrs < 22 yrs,
Adult: At least 22 yrs
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| Detailed Study Protocol Parameters |
| Study Objectives |
This is an extended follow-up of the premarket cohort. The purpose of the study is to evaluate the long term safety and effectiveness of the MED-EL EAS Implant in implanted subjects out to 5 years post-activation. It is a prospective, multicenter, non-controlled, non-randomized study.
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| Study Population |
Up to 68 subjects from the original pivotal study who remain enrolled in the study, implanted with a MED-EL EAS device and have not reached their 5 year post-activation interval will be invited to participate.
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| Sample Size |
The sample size requirements are based on the desire for adequate power for the primary effectiveness endpoint. The hypothesis test is a paired one-sample non-inferiority test of the mean CNC word score. The test will be performed at the one-sided 0.05 alpha level based on a 10% non-inferiority margin. The planned minimum sample size of 55 subjects would yield 90% power for this endpoint, based on an assumed difference of zero and a standard deviation of 25. A higher degree of power would be maintained for a smaller standard deviation.
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| Key Study Endpoints |
Effectiveness endpoints:
The primary effectiveness endpoint will be CUNY sentence test score in noise at five years (60 months) post-implantation compared to the 12-month follow-up interval, measured in two conditions: CI alone and EAS in the implanted ear.
The secondary effectiveness endpoints will be 1) CNC word score in quiet at five years (60 months) post-implantation compared to the 12-month follow-up interval, measured in two conditions: CI alone and EAS in the implanted ear; and 2) global score on the APHAB questionnaire, completed based responses in the everyday listening condition at five years (60 months) post-implantation compared to the 12-month follow-up interval.
Safety endpoints:
The primary safety endpoint will be the number and proportion of subjects experiencing device-related adverse events. Expected adverse events include those listed in the original clinical trial protocol, in particular:
Profound or total loss of residual hearing
Infection or inflammation
Vertigo, dizziness, or balance problems
Tinnitus
Implant migration/extrusion
Skin flap problems
Device-related or programming problems
Uncomfortable sounds during stimulation
Temporary pain or numbness
Device failure leading to explantation
The secondary safety endpoint is residual hearing at five years (60 months) post-implantation that will be summarized and presented as the amount of low-frequency pure-tone average (125, 250, 500, 750, and 1000Hz) shift, the degree of residual hearing, and as a function of the HEARING scale.
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| Follow-up Visits and Length of Follow-up |
5 years post-activation of the device for each subject.
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
50
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| Actual Number of Sites Enrolled |
7
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| Patient Follow-up Rate |
98% at 5 years*
The primary endpoint for this investigation is 5 years post-activation of the MedEl EAS System.
As of December 11, 2019, 49 out of 50 enrolled subjects have reached this designated study phase.
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| Final Safety Findings |
A total of eight (8) serious Adverse Events (AEs) occurred during this PAS. Serious AEs in seven (7) subjects, who had significant residual hearing loss in the implanted ear with a low-frequency Pure Tone Average (PTA) across 125-1000 Hz equal or greater than 90 dB HL, were reported during the PAS, but only one (1) was related to internal device failure that was resolved after revision surgery. Five (5) out of seven (7) subjects, who
lost residual hearing but still have aidable low-frequency hearing (i.e., threshold less than or equal to 80 dB HL at 125 Hz), are continuing to use the acoustic unit and demonstrate combined electric and acoustic (EAS) benefit. Two (2) out of seven (7) subjects continue to demonstrate benefit with
electric-alone stimulation. There were no unanticipated adverse device effects reported. In general, the type and frequency of AEs and serious AEs occurring over the course of this study up to 5 year post-activation interval are mostly related to the loss of residual hearing, which is
an anticipated AE. In total, 32% (16 out of 49) subjects lost their residual hearing (PTA across 125-1000 Hz greater than or equal to 90 dB
HL) in the implanted ear from post-implant surgery to 5-yr follow-up visit (Note: 9 out of 16 cases occurred within 1-yr follow-up visit).
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| Final Effect Findings |
The mean CUNY (sentence in noise) scores achieved with the MedEl EAS system (i.e., the primary effectiveness endpoint) at the 5-year
post activation follow-up is significantly lower than that at the 1-year post activation follow-up. However, for those 39 out of 49 subjects who have aidable residual hearing in the implanted ear (i.e., threshold less than or equal to 80 dB HL at 125 Hz), the CUNY scores still demonstrate an improvement at the 5-year post activation follow-up compared to the pre-operative baseline condition with hearing aids. For those 10 out of 49 who have completely lost residual hearing in the implanted ear, the mean CUNY (sentence in noise) score achieved with the MedEl EAS system at the 5-
year post activation follow-up is not superior to that at the pre-operative baseline condition with hearing aids. Through the 5-year post-activation follow-up, the MedEl EAS System improves overall mean CNC (words in quiet) scores and mean AHPAB scores compared with the
pre-implant baseline condition and the improvement is sustainable over the five years of follow up.
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| Study Strengths & Weaknesses |
This is a single arm study with no comparator; however, the subjects served as their own control. It is a long-term study (up to 5 years post-implantation) with a high follow-up rate.
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| Recommendations for Labeling Changes |
Yes. A labeling update is recommended to reflect the findings of the study.
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