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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Esteem New Enrollment 2

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Study Status Completed
Application Number P090018 / PAS003
Date Current Protocol Accepted 02/24/2020
Study Name Esteem New Enrollment 2
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Device Subjects Serve as Own Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description 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.
Study Population Description 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.
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.
Data Collection 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.
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.
Interim or Final Data Summary
Actual Number of Patients Enrolled 59
Actual Number of Sites Enrolled 5
Patient Follow-up Rate 85% at 4-month timepoint, 84% at 10-month timepoint
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.

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.
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.
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).

Esteem New Enrollment 2 Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 03/18/2016 04/08/2016 Overdue/Received
one year report 09/18/2016 09/19/2016 Overdue/Received
18 month report 03/18/2017 03/17/2017 On Time
unscheduled report 06/28/2017 06/28/2017 On Time
two year report 09/18/2017 09/18/2017 On Time
three year report 09/17/2018 09/18/2018 Overdue/Received
four year report 09/17/2019 09/17/2019 On Time
five year report 09/17/2020 09/21/2020 Overdue/Received
final report 11/01/2021 11/02/2021 Overdue/Received

Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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