|
General |
Study Status |
Completed |
Application Number / Requirement Number |
P090018 / PAS001 |
Date Original Protocol Accepted |
03/17/2010
|
Date Current Protocol Accepted |
08/16/2010
|
Study Name |
Extended Follow-up of PMA study
|
Device Name |
ESTEEM TOTALLY IMPLANTABLE HEARING SYSTEM
|
General Study Protocol Parameters |
Study Design |
Prospective Cohort Study
|
Data Source |
New Data Collection
|
Comparison Group |
No Control
|
Analysis Type |
Analytical
|
Study Population |
Transit. Adolescent A (distinctively) : 18-21 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
Interim or Final Data Summary |
Actual Number of Patients Enrolled |
51
|
Actual Number of Sites Enrolled |
3
|
Patient Follow-up Rate |
98% at 4 months, 98% at 10 months, 65% at 2 years, 73% at 3 years, 86% at 4 years, 100% at 5 years
|
Final Safety Findings |
A total of three (3) SADEs in three (3) subjects have been reported during the PAS, in the second through fifth year of post-implant follow-up. These included a sore behind the implant ear caused by glasses requiring surgical intervention; once incision breakdown after battery replacement procedure; and one involved progression of external auditory canal abscess to transcanal infection, requiring explantation of the device.
|
Final Effect Findings |
Overall mean Speech Reception Threshold (SRT) scores show significant improvement with Esteem compared with pre-implant baseline aided condition through the 4-year follow-up. Through 4-year follow-up, the 95% LCB for the mean difference relative to baseline aided condition ranges from +6.3 dB to +10.9 dB, greater than the +5 dB criteria for superiority. At the 5-year follow-up, the 95% LCB for the mean difference relative to baseline aided condition is +0.8 dB, greater than the -5 dB criteria for non- inferiority. Through the 4-year follow-up, the Esteem improves Word Recognition Scores (WRS) in a majority of subjects (ranging from 64% to 79%) compared to the pre-implant aided condition. At the 5-year follow- up, the Esteem improves word recognition scores in 49% of subjects, and scores the same in 41% of subjects compared to the pre-implant aided condition.
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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 high follow-up rate.
|
Recommendations for Labeling Changes |
Yes. A labeling update is recommended regarding the lifetime of the battery, long term device effectiveness and a newly identified device failure ¿fluid ingress due to header abrasion¿ is of consideration.
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