PMEI Post-Market Clinical Follow-Up

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.

Official Title
-----------------
PMEI Post-Market Clinical Follow-Up

Conditions
-----------------
Pre-existing Condition

Intervention / Treatment
-----------------
* Device: PMEIs


Participation Criteria
=================
Eligibility Criteria
-----------------
• Inclusion Criteria: Implanted with a MED-EL PMEI; initial implantation or revision implantation receiving a MED-EL PMEI • Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Total Ossicular Replacement Prostheses: The primary objective for the total ossicular replacement prostheses was to achieve an ABG ≤ 20 dB by at least 25 % of the patients after the PMEI implantation | Device: PMEIs<br>* To evaluate audiological outcomes post-operatively, the air-bone gap (ABG) was assessed. To evaluate safety of the devices, adverse events were collected.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. To assess whether implantation of PMEI affected residual hearing pre- and post-operative bone conduction thresholds were evaluated.<br>|
| 2<br>Partial Ossicular Replacement Prostheses: The primary objective for the partial ossicular replacement prostheses was to achieve an ABG ≤ 20 dB by at least 53.8 % of the patients after the PMEI implantation. | Device: PMEIs<br>* To evaluate audiological outcomes post-operatively, the air-bone gap (ABG) was assessed. To evaluate safety of the devices, adverse events were collected.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. To assess whether implantation of PMEI affected residual hearing pre- and post-operative bone conduction thresholds were evaluated.<br>|
| 3<br>Stapesplasty Prostheses: The primary objective for the stapes prostheses was to achieve an ABG ≤ 20 dB by at least 86 % of the patients after the PMEI implantation. | Device: PMEIs<br>* To evaluate audiological outcomes post-operatively, the air-bone gap (ABG) was assessed. To evaluate safety of the devices, adverse events were collected.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. To assess whether implantation of PMEI affected residual hearing pre- and post-operative bone conduction thresholds were evaluated.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ABG | 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. | A post-operative minimum and maximum follow-up period was not defined. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events | To collect device, surgery or procedure related adverse events and bone conduction thresholds | A post-operative minimum and maximum follow-up period was not defined. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
passive middle ear implant