PMEI Post-Market Clinical Follow-Up
Sponsor
MED-EL Elektromedizinische Geräte GesmbH (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05565339
Collaborator
(none)
165
11
21.8
15
0.7
Study Details
Study Description
Brief Summary
Confirm safety and performance of passive middle ear implants (PMEIs) in subjects with hearing loss that makes implantation of a PMEI necessary
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Collect retrospective audiological and safety results of PMEI implanted subjects followed up for three months (± four weeks) post-operatively.
Study Design
Study Type:
Observational
Anticipated Enrollment
:
165 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
PMEI Post-Market Clinical Follow-Up
Actual Study Start Date
:
Mar 8, 2021
Anticipated Primary Completion Date
:
Dec 31, 2022
Anticipated Study Completion Date
:
Dec 31, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 1 Total Ossicular Replacement Prosthesis |
Device: PMEIs
To evaluate audiological outcomes three months (± four weeks) post-operatively, the air-bone gap (ABG) will be assessed. The primary objective is to achieve an ABG ≤ 20 dB by more than 50 % of patients after PMEI implantation. To evaluate safety of the devices adverse events will be collected in the time period beginning with implantation until three months (± four weeks) after the implantation. To assess whether implantation of PMEI affects residual hearing pre- and post-operative bone conduction thresholds will be evaluated.
|
| 2 Partial Ossicular Replacement Prosthesis |
Device: PMEIs
To evaluate audiological outcomes three months (± four weeks) post-operatively, the air-bone gap (ABG) will be assessed. The primary objective is to achieve an ABG ≤ 20 dB by more than 50 % of patients after PMEI implantation. To evaluate safety of the devices adverse events will be collected in the time period beginning with implantation until three months (± four weeks) after the implantation. To assess whether implantation of PMEI affects residual hearing pre- and post-operative bone conduction thresholds will be evaluated.
|
| 3 Stapesplasty Prosthesis |
Device: PMEIs
To evaluate audiological outcomes three months (± four weeks) post-operatively, the air-bone gap (ABG) will be assessed. The primary objective is to achieve an ABG ≤ 20 dB by more than 50 % of patients after PMEI implantation. To evaluate safety of the devices adverse events will be collected in the time period beginning with implantation until three months (± four weeks) after the implantation. To assess whether implantation of PMEI affects residual hearing pre- and post-operative bone conduction thresholds will be evaluated.
|
Outcome Measures
Primary Outcome Measures
- ABG [three months (± four weeks)]
collect three months (± four weeks) post-operative PTA4 ABG results. It is expected that more than 50 % of the patients will achieve an ABG ≤ 20 dB with a PMEI at three months (± four weeks) post-operatively.
Secondary Outcome Measures
- adverse events [three months (± four weeks)]
collect device, surgery or procedure related adverse events and bone conduction thresholds
Eligibility Criteria
Criteria
Ages Eligible for Study:
0 Years
to 99 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
-
Presence of a conductive or mixed hearing loss before implantation of a MED-EL PMEI as indicated by audiometric testing
-
Or presence of a pre-existing condition before implantation of a MED-EL PMEI, which makes the implantation of a MED-EL PMEI necessary
-
Or Implanted with a MED-EL PMEI; initial implantation or revision implantation receiving a MED-EL PMEI
Exclusion Criteria:
none
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Linz Kepler Universitätsklinikum GmbH, Klinik für Hals-, Nasen- und Ohrenheilkunde | Linz | Oberösterreich | Austria | 4020 |
| 2 | Klinikum Wels-Grieskirchen GmbH, Abteilung für Hals-, Nasen- und Ohrenkrankheiten, Logopädie | Wels | Oberösterreich | Austria | 4600 |
| 3 | Universitätsklinikum St. Pölten, Klinische Abteilung für Hals-Nasen-Ohren | Sankt Pölten | Austria | 3100 | |
| 4 | Wiener Gesundheitsverbund, Klinik Landstraße, Hals-Nasen-Ohren-Allgemeine Ambulanz | Wien | Austria | 1030 | |
| 5 | Universitätskliniken der MedUni Wien/AKH Wien, Universitätsklinik für Hals-, Nasen- und Ohrenkrankheiten | Wien | Austria | 1090 | |
| 6 | Universitätsklinikum Erlangen, Hals-Nasen-Ohren-Klinik, Kopf- und Halschirurgie der Universität Erlangen-Nürnberg | Erlangen | Germany | 91054 | |
| 7 | Universitätsklinikum Freiburg, Universitätsklinik für Hals, - Nasen und Ohrenheilkunde Sektionsleitung Experimentell-klinische Otologie | Freiburg im Breisgau | Germany | 79106 | |
| 8 | Universitätsmedizin Göttingen, Klinik für Hals-Nasen-Ohrenheilkunde | Göttingen | Germany | 37075 | |
| 9 | Medizinische Hochschule Hannover, Klinik für HNO-Krankheiten | Hannover | Germany | 30625 | |
| 10 | Zentrum für Mittelohrchirurgie, Belegabteilung für Abteilung Hals-Nasen-Ohrenheilkunde | Lünen | Germany | 44536 | |
| 11 | Center of Hearing and Speech Medincus, Clinical Trials Department | Nadarzyn | Kajetany | Poland | 05-830 |
Sponsors and Collaborators
- MED-EL Elektromedizinische Geräte GesmbH
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
MED-EL Elektromedizinische Geräte GesmbH
ClinicalTrials.gov Identifier:
NCT05565339
Other Study ID Numbers:
- 2020PMEI001
First Posted:
Oct 4, 2022
Last Update Posted:
Dec 5, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by MED-EL Elektromedizinische Geräte GesmbH
Additional relevant MeSH terms: