PMEI Post-Market Clinical Follow-Up
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 497
- Locations
- 11
- Primary Endpoint
- ABG
Study Overview
Brief Summary
Confirm safety and performance of passive middle ear implants (PMEIs) in subjects with pre-existing condition which made the implantation of a MED-EL PMEI necessary
Detailed Description
Collect retrospective audiological and safety results of PMEI implanted subjects. A post-operative minimum and maximum follow-up period was not defined. The mean of the post-operative follow-up period of all patients was calculated.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 0 Years to 99 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Implanted with a MED-EL PMEI; initial implantation or revision implantation receiving a MED-EL PMEI
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
ABG
Time Frame: A post-operative minimum and maximum follow-up period was not defined.
To collect post-operative PTA4 ABG results. It was expected to achieve a post-operative ABG ≤ 20 dB with a PMEI, by at least 25 % of the total ossicular replacement prostheses patients, by at least 53.8 % of the partial ossicular replacement prostheses patients, and by at least 86 % of the stapes prostheses patients.
Secondary Outcomes
- adverse events(A post-operative minimum and maximum follow-up period was not defined.)