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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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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MED-EL New Enrollment SSD/AHL Study


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General
Study Status Study Pending
Application Number P000025 S104/ PAS001
Date Current Protocol Accepted  
Study Name MED-EL New Enrollment SSD/AHL Study
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 Child: 2-12 yrs, Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description To determine the long-term safety and effectiveness outcomes of cochlear implantation for single-sided deafness and asymmetric hearing loss, 65 subjects will be recruited into this singlesubject, repeated measures study. Twelve of the subjects will be between five and 11 years, 11 months of age, while nine subjects will be between 12 and 17 years, 11 months of age. Six centers across the United States and Canada will recruit subjects into this study. Pre-operative speech perception, quality of life, and localization (where possible) assessments will be conducted. All subjects will receive a MED-EL Cochlear Implant and will subsequently be fit with an FDA-approved audio processor. Post-operative evaluations will occur at three, six, 12, 24, and 36 months post-activation of the CI. Data will be analyzed from the 12-month and 36-month follow-up intervals and compared to baseline data.

This is a new enrollment study and the primary objective of this study is to evaluate the long-term effectiveness of cochlear implantation in patients ages five years and older with single-sided deafness or asymmetric hearing loss. The secondary objective of this study is to evaluate the long-term safety of cochlear implantation in patients ages five years and older with single-sided deafness or asymmetric hearing loss.
Study Population Description 65 subjects with SSD or AHL who are above five years of age will be recruited. Among the 65 subjects, 44 will be adults aged 18 years and older; 12 subjects will be between 5 and 12 years of age; and 9 subjects will be between 12 and 18 years of age. Subjects will be recruited from six investigational sites. SSD/AHL is defined as profound hearing loss (PTA = 90 dB HL across 500, 1000, 2000, and 4000 Hz) and less than or equal to 5% CNC word in quiet score in the ear to be implanted and normal hearing or mild-to-moderate hearing loss (PTA less than or equal to 55 dB HL) in the contralateral ear.

Subjects will be implanted with an FDA-approved MED-EL cochlear implant system. After implantation, subjects will be fit with a currently-approved audio processor.
Sample Size Sixty-five subjects will be enrolled in this study. Of the 65 subjects, 12 will be between the ages of five and 12 years, while nine subjects will be between 12 and 18 years of age.

The basis for the sample size calculation is speech in noise performance on AzBio sentences in noise in the speech front, noise to the better hearing ear condition; the pre-operative, best aided condition compared to 12 months post-operative, normal hearing ear and CI.

The sample size calculation is based on data from the University of North Carolina clinical trial (G140050) on SSD and AHL subjects. In the SSD group on AzBio, the average pre-operative best aided score was 18.3% (SD=18.2%) and at 12-month testing, the average score with the CI on was 52.6% (SD=21.4%). In the AHL group, subjects reached an average score of 11.9% (SD=17.0%) in the best aided pre-operative condition and at 12-month testing reached an average score of 29.4% (SD=22.6%) with the CI on.

Using these data as basis for the sample size calculation, with a power of 90% and an alpha-level of 0.05 for a one-sided Paired sample t-test (or the Wilcoxon signed-rank test for the AHL group because the data were not normally distributed), a total sample size of 43 subjects would be a sufficient sample, but 65 subjects are proposed, to include 21 pediatric subjects between five and 18 years of age, and to account for potential subject loss of 20% over the duration of the study. Specifically, 12 subjects will be recruited between the ages of five and 12 years of age, while nine subjects will be recruited between the ages of 12 and 18 years of age.
Data Collection Primary Endpoint:

Improvement on speech in noise when speech is presented to the front and noise is presented to the acoustic hearing (contralateral) ear. The pre-operative, best-aided score will be compared to the 12- month and 36-month CI score for AzBio sentences in noise. Improvement is defined as greater than or equal to 10 percentage points.

Secondary Endpoints:

Speech in noise in two spatial conditions will demonstrate similar performance from the preoperative, best-aided score to the CI score at 12 and 36 months postactivation. AzBio sentence in noise score will be summarized for two conditions: speech and noise presented from the front as well as speech presented to the front and noise presented to the CI ear.

Speech perception in quiet will be summarized for the CI ear and the contralateral ear at the preoperative, 12-month, and 36-month intervals. The CI ear is expected to demonstrate improvement (greater than or equal to 10 percentage point change), while the contralateral ear is expected to demonstrate no change.

Subjective data will be collected via the Speech, Spatial, and Qualities of Hearing Scale (SSQ) and a Quality of Life questionnaire. Responses will be summarized from the pre-operative, 12-month, and 36-month intervals.

Device-related adverse events will be collected and reported throughout the duration of the study. Events will be reported as the number and proportion of subjects experiencing them.

Exploratory Analysis:

Efforts will be made to collect localization data; however, not every site will have the capability of performing this testing. Subjects will travel to sites with sufficient facilities to test localization, as they are able. When possible, root mean square (RMS) error will be reported from the pre-operative, 12-month, and 36-month intervals.
Follow-up Visits and Length of Follow-up The study is anticipated to last for six years from enrollment through final data analysis.

Individual subject participation will last for approximately 36 months or three years.


MED-EL New Enrollment SSD/AHL Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 01/17/2020    
one year report 07/18/2020    
18 month report 01/16/2021    
two year report 07/18/2021    
three year report 07/18/2022    
four year report 07/18/2023    


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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