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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P090018 / PAS003 |
| Date Original Protocol Accepted |
04/16/2010
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| Date Current Protocol Accepted |
02/24/2020
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| Study Name |
Esteem New Enrollment 2
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| Device Name |
ESTEEM TOTALLY IMPLANTABLE HEARING SYSTEM
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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) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
This is a new enrollment study. It is a prospective, non-randomized, multicenter study, and it aims to evaluate the safety and efficacy of the device implanted by newly-trained surgeons in subjects suffering from moderate to severe hearing loss.
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| Study Population |
Subjects 18 years of age and older who have moderate to severe sensorineural hearing loss (HL) defined by Pure Tone Average (PTA), have a healthy middle ear, have an unaided speech discrimination score of equal to or better than 40%, and have previously worn a hearing aid for a minimum of 30 days are eligible for inclusion in the Post Approval Study.
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| Sample Size |
120 subjects in 5 to 10 investigational sites. The sample size is based on testing the following hypothesis:
Facial Pareses/paralysis:
Based upon a null hypothesis of 7% and a hypothesized true rate of 2% of facial paresis/paralysis, 109 subjects at 1 month would provide at least 80% power for testing the hypothesis.
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| Key Study Endpoints |
To demonstrate that the Esteem® System is as effective as or better than the hearing aid for improving speech discrimination (intelligibility) as shown by the word recognition score at 50 dB.
Primary Endpoints:
1) Comparison of the speech reception threshold (SRT) using the Esteem® System as compared to the pre-implant aided condition.
2) Comparison of word recognition score using the Esteem® as compared to the pre-implant aided condition.
3) The analysis of the incidence of SADEs and device failures and replacements at each follow-up.
4) The analysis of the incidence of facial pareses/paralysis at 1 month follow-up.
5) Comparison of the bone conduction threshold with forehead placement compared to the pre-implant bone conduction threshold.
Secondary Endpoints:
1) To show that the Esteem® System improves Quality-of-Life when compared to the baseline aided condition as shown by APHAB scores.
2) To gather subject feedback and comments on the use of the Esteem® System relative to the pre-implant hearing aid (aided condition) as shown by the Esteem® Questionnaire.
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| Follow-up Visits and Length of Follow-up |
The subjects will be followed for 1 year.
Device will be activated during activation visit (8weeks+/- 2week post implant. Subjects will be followed at 1, 4 and 10 months post-activation.
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
59
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| Actual Number of Sites Enrolled |
5
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| Patient Follow-up Rate |
85% at 4-month timepoint, 84% at 10-month timepoint
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| Final Safety Findings |
Serious Adverse Events
Two adverse events were reported as serious adverse events. One event was related to extensive fibrotic tissue discovered after the patient reported diminished performance with the device. This device was explanted. The other event was related to persistent acoustic feedback, which was resolved when the patient received a new external processor. There were three other serious adverse events adjudicated to be procedure, and not device-related, and therefore removed from the safety analysis. These three events were reported to be due to infection, and the devices were ultimately explanted.
Facial Nerve Injury
A total of 110 Subjects contributed to this endpoint. There were three reported events of facial paresis/ weakness. All three reported events resolved with no residual side effects. There were no reported events of facial paralysis or lasting facial paresis. Statistical analysis shows the incidence of facial paresis/paralysis is no greater than was reported in original Esteem PMA pivotal clinical trial.
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| Final Effect Findings |
Final effectiveness findings (key endpoints):
Speech Reception Threshold (SRT)
This co-primary effectiveness endpoint is a comparison of the speech reception threshold (SRT) using the Esteem as compared to the pre-implant aided condition. Both non-inferiority and superiority hypotheses were evaluated. Mean improvement at the 4-month timepoint was 1.1 dB, and 5.3 at the 10-month timepoint. In total, 72% of subject SRTs improved or were the same at the 4-month timepoint, and 78% improved or were the same at the 10-month timepoint, meeting the non-inferiority criterion. Neither timepoint met the superiority criterion.
Word Recognition Score
This co-primary effectiveness endpoint is a comparison of the word recognition score using the Esteem compared to the word recognition score in the preimplant aided condition at 50 dB. Both non-inferiority and superiority hypotheses were evaluated. The mean difference for WRS at the 4-month timepoint was -4.7% and for the 10-month timepoint it was -2.2%. In total, at the 4-month time point 80% of subjects performed better or the same compared to their hearing aid, and 84% at the 10-month timepoint. Both of these values are greater than the -10 criterion set for non-inferiority. Neither timepoint supported a superiority claim.
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| Study Strengths & Weaknesses |
This study met its non-inferiority criterion for effectiveness, but not the superiority criterion. The safety endpoints were also met, though throughout the study duration there were inconsistences in designation of serious adverse events. Due to a slow rate of enrollment, the study modified it’s long-term endpoint from 5 years to 1 year, which limits interpretation of long-term safety and effectiveness.
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| Recommendations for Labeling Changes |
The labeling should be changed to reflect the final study results for each endpoint. The sponsor should add results from the safety (i.e., facial paresis) and effectiveness endpoints out to 1-year (SRT and WRS endpoints).
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