Pre-existing ConditionNCT05565339
PMEI Post-Market Clinical Follow-Up
An observational study of Pre-existing Condition, run by MED-EL Elektromedizinische Geräte GmbH at 11 sites in 3 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 0 to 99 years
- Conditions the study is for
- Pre-existing Condition
- What is being tested?
- PMEIs
- Type of treatment
- Medical device
- How many people
- 497 participants
- Where
- 11 sitesin 3 countries
- Study dates
- 29 Sep 2020to 2 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 99 years
- All sexes
- Child, Adult, Older adult
Study population: The study population included MED-EL PMEI implanted patients with a pre-existing condition which made the implantation of a MED-EL PMEI necessary.
- Inclusion Criteria: Implanted with a MED-EL PMEI; initial implantation or revision implantation receiving a MED-EL PMEI
- Exclusion Criteria: None
Trial locations and contacts
11 sites in 3 countries.
11 sites in 3 countries
Austria5 sites
Linz Kepler Universitätsklinikum GmbH, Klinik für Hals-, Nasen- und Ohrenheilkunde
Linz, Upper Austria, 4020
Universitätsklinikum St. Pölten, Klinische Abteilung für Hals-Nasen-Ohren
Sankt Pölten, 3100
Wiener Gesundheitsverbund, Klinik Landstraße, Hals-Nasen-Ohren-Allgemeine Ambulanz
Vienna, 1030
Universitätskliniken der MedUni Wien/AKH Wien, Universitätsklinik für Hals-, Nasen- und Ohrenkrankheiten
Vienna, 1090
Klinikum Wels-Grieskirchen GmbH, Abteilung für Hals-, Nasen- und Ohrenkrankheiten, Logopädie
Wels, Upper Austria, 4600
Germany5 sites
Universitätsklinikum Erlangen, Hals-Nasen-Ohren-Klinik, Kopf- und Halschirurgie der Universität Erlangen-Nürnberg
Erlangen, 91054
Universitätsklinikum Freiburg, Universitätsklinik für Hals, - Nasen und Ohrenheilkunde Sektionsleitung Experimentell-klinische Otologie
Freiburg im Breisgau, 79106
Universitätsmedizin Göttingen, Klinik für Hals-Nasen-Ohrenheilkunde
Göttingen, 37075
Medizinische Hochschule Hannover, Klinik für HNO-Krankheiten
Hanover, 30625
Zentrum für Mittelohrchirurgie, Belegabteilung für Abteilung Hals-Nasen-Ohrenheilkunde
Lünen, 44536
Poland1 site
Center of Hearing and Speech Medincus, Clinical Trials Department
Nadarzyn, Kajetany, 05-830
About this study
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
Read the 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.
- Conditions
- Pre-existing Condition
- Being tested
- PMEIs
- Keywords
- passive middle ear implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PMEIsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | 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 Receives: Device: PMEIs | |
| 2 | 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. Receives: Device: PMEIs | |
| 3 | 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. Receives: Device: PMEIs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: A post-operative minimum and maximum follow-up period was not defined.
Secondary outcomes (1)
adverse events
To collect device, surgery or procedure related adverse events and bone conduction thresholds
Measured: A post-operative minimum and maximum follow-up period was not defined.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start29 Sep 2020
- Primary completion2 Nov 2023
- Study completion2 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pre-existing ConditionStudies of the same condition, open and under way.
- More trials run by MED-EL Elektromedizinische Geräte GmbHThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 497 participants (actual)
Sponsor and investigators
- Lead sponsor
- MED-EL Elektromedizinische Geräte GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05565339
- Sponsor's protocol ID
- 2020PMEI001
- Status last verified
- Dec 2023
- First submitted
- 29 Sep 2022
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wolfram W, Zwittag PM, Niederwanger L, Rubicz N, Sprinzl G, Magele A, Beutner D, Bevis N, Schimanski E, Arndt S, Offergeld C, Arnoldner C, Riss D, Skarzynski PH, Plichta L, Hornung J, Taha L, Lenarz T, Busch S, Windisch F, Loader B. Clinical outcomes of 188 patients implanted with Med-El stapes prostheses. Eur Arch Otorhinolaryngol. 2026 Feb;283(2):781-790. doi: 10.1007/s00405-025-09733-x. Epub 2025 Oct 15.
PubMed 41094222Beutner D, Bevis N, Loader B, Windisch F, Arndt S, Offergeld C, Wolfram W, Niederwanger L, Zwittag PM, Rubicz N, Schimanski E, Arnoldner C, Riss D, Skarzynski PH, Plichta L, Hornung J, Taha L, Lenarz T, Busch S, Magele A, Sprinzl G. Safety and Effectiveness of the Titanium mAXIS Stapes Prosthesis: Multicentric Short-Term Outcome. Otol Neurotol. 2025 Jun 1;46(5):561-566. doi: 10.1097/MAO.0000000000004462. Epub 2025 Feb 19.
PubMed 40059729Schimanski E, Lenarz T, Busch S, Arndt S, Offergeld C, Arnoldner C, Riss D, Hornung J, Taha L, Zwittag PM, Rubicz N, Beutner D, Bevis N, Loader B, Windisch F, Sprinzl G, Magele A, Wolfram W, Niederwanger L, Plichta L, Skarzynski PH. Safety and performance of the new med-el total ossicular replacement prostheses. Eur Arch Otorhinolaryngol. 2024 Nov;281(11):5687-5697. doi: 10.1007/s00405-024-08784-w. Epub 2024 Jul 13.
PubMed 39001922Rasse T, Niederwanger L, Hornung J, Taha L, Arndt S, Offergeld C, Beutner D, Bevis N, Lenarz T, Teschner M, Schimanski E, Georg Sprinzl, Magele A, Skarzynski PH, Plichta L, Arnoldner C, Riss D, Loader B, Windisch F, Rubicz N, Zwittag PM. Short-term safety and effectiveness of the mCLIP partial prosthesis. Eur Arch Otorhinolaryngol. 2024 May;281(5):2353-2363. doi: 10.1007/s00405-023-08359-1. Epub 2023 Dec 22.
PubMed 38133806
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PMEI Post-Market Clinical Follow-Up
- ClinicalTrials.gov ID
- NCT05565339
- Acronym / sponsor ID
- 2020PMEI001
- Conditions
- Pre-existing Condition
- Keywords
- passive middle ear implant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 497 participants (actual)
- Lead sponsor
- MED-EL Elektromedizinische Geräte GmbHIndustry (pharma, biotech, devices)
- Study start
- 29 Sep 2020 (actual)
- Primary completion
- 2 Nov 2023 (actual)
- Study completion
- 2 Nov 2023 (actual)
- First posted
- 4 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: PMEIsTotal 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 |
| 2 | – | Device: PMEIsPartial 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. |
| 3 | – | Device: PMEIsStapesplasty 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. |
Who may qualify
- Ages
- 0 to 99 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The study population included MED-EL PMEI implanted patients with a pre-existing condition which made the implantation of a MED-EL PMEI necessary.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PMEIsTo 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. | Device | 1, 2, 3 |
Primary outcome
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.
1 secondary outcome
adverse events
Time frame: A post-operative minimum and maximum follow-up period was not defined.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Derived from this study: PubMed 41094222Wolfram W, Zwittag PM, Niederwanger L, Rubicz N, Sprinzl G, Magele A, Beutner D, Bevis N, Schimanski E, Arndt S, Offergeld C, Arnoldner C, Riss D, Skarzynski PH, Plichta L, Hornung J, Taha L, Lenarz T, Busch S, Windisch F, Loader B. Clinical outcomes of 188 patients implanted with Med-El stapes prostheses. Eur Arch Otorhinolaryngol. 2026 Feb;283(2):781-790. doi: 10.1007/s00405-025-09733-x. Epub 2025 Oct 15.
- Derived from this study: PubMed 40059729Beutner D, Bevis N, Loader B, Windisch F, Arndt S, Offergeld C, Wolfram W, Niederwanger L, Zwittag PM, Rubicz N, Schimanski E, Arnoldner C, Riss D, Skarzynski PH, Plichta L, Hornung J, Taha L, Lenarz T, Busch S, Magele A, Sprinzl G. Safety and Effectiveness of the Titanium mAXIS Stapes Prosthesis: Multicentric Short-Term Outcome. Otol Neurotol. 2025 Jun 1;46(5):561-566. doi: 10.1097/MAO.0000000000004462. Epub 2025 Feb 19.
- Derived from this study: PubMed 39001922Schimanski E, Lenarz T, Busch S, Arndt S, Offergeld C, Arnoldner C, Riss D, Hornung J, Taha L, Zwittag PM, Rubicz N, Beutner D, Bevis N, Loader B, Windisch F, Sprinzl G, Magele A, Wolfram W, Niederwanger L, Plichta L, Skarzynski PH. Safety and performance of the new med-el total ossicular replacement prostheses. Eur Arch Otorhinolaryngol. 2024 Nov;281(11):5687-5697. doi: 10.1007/s00405-024-08784-w. Epub 2024 Jul 13.
- Derived from this study: PubMed 38133806Rasse T, Niederwanger L, Hornung J, Taha L, Arndt S, Offergeld C, Beutner D, Bevis N, Lenarz T, Teschner M, Schimanski E, Georg Sprinzl, Magele A, Skarzynski PH, Plichta L, Arnoldner C, Riss D, Loader B, Windisch F, Rubicz N, Zwittag PM. Short-term safety and effectiveness of the mCLIP partial prosthesis. Eur Arch Otorhinolaryngol. 2024 May;281(5):2353-2363. doi: 10.1007/s00405-023-08359-1. Epub 2023 Dec 22.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pre-existing Condition, run by MED-EL Elektromedizinische Geräte GmbH at 11 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Austria, Germany, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ABG (time frame: A post-operative minimum and maximum follow-up period was not defined.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05565339, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023; AzTrials last refreshed its copy on 6 Nov 2026.