NCT05565339 is a clinical trial of PMEIs in Pre-existing Condition, sponsored by MED-EL Elektromedizinische Geräte GesmbH.

Who is sponsoring NCT05565339?

NCT05565339 is sponsored by MED-EL Elektromedizinische Geräte GesmbH.

What drugs are being tested in NCT05565339?

Interventions in NCT05565339: PMEIs.

What condition does NCT05565339 study?

NCT05565339 studies Pre-existing Condition.

Is NCT05565339 still recruiting?

NCT05565339 is currently completed. Last updated 15 December 2023.

Last reviewed 2023-12-15 · How we verify

NCT05565339

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

PMEI Post-Market Clinical Follow-Up

Completed Last updated 15 December 2023

What this trial tests

trial testing PMEIs in Pre-existing Condition in 497 participants. Completed in 2 November 2023.

Timeline

29 September 2020

Primary endpoint
2 November 2023

2 November 2023

Quick facts

Lead sponsor	MED-EL Elektromedizinische Geräte GesmbH
Status	Completed
Study type	OBSERVATIONAL
Enrollment	497
Start date	29 September 2020
Primary completion	2 November 2023
Estimated completion	2 November 2023
Sites	11 locations across Austria, Germany, Poland

Drugs / interventions tested

PMEIs

Conditions studied

Pre-existing Condition — all drugs for Pre-existing Condition →

Sponsor

MED-EL Elektromedizinische Geräte GesmbH — full company profile →

Who can join

Adults 0 to 99, any sex, with Pre-existing Condition. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Short-term safety and effectiveness of the mCLIP partial prosthesis.
Rasse T, Niederwanger L, Hornung J, Taha L, et al · · 2024 · cited 1× · PMID 38133806 · DOI 10.1007/s00405-023-08359-1
Multicenter study results of the med-el partial ossicular replacement prostheses.
Arndt S, Offergeld C, Wolfram W, Niederwanger L, et al · · 2026 · PMID 41243016 · DOI 10.1007/s00405-025-09799-7
Clinical outcomes of 188 patients implanted with Med-El stapes prostheses.
Wolfram W, Zwittag PM, Niederwanger L, Rubicz N, et al · · 2026 · PMID 41094222 · DOI 10.1007/s00405-025-09733-x
Short-term audiological outcomes of the mCLIP ARC ball joint prosthesis- a retrospective multicenter study.
Beutner D, Bevis N, Arndt S, Offergeld C, et al · · 2025 · PMID 40439925 · DOI 10.1007/s00405-025-09475-w
Safety and performance of the new med-el total ossicular replacement prostheses.
Schimanski E, Lenarz T, Busch S, Arndt S, et al · · 2024 · PMID 39001922 · DOI 10.1007/s00405-024-08784-w

Verify or expand the search:

Other MED-EL Elektromedizinische Geräte GesmbH trials

Trials by the same sponsor.

NCT07213505 — This Clinical Investigation Assesses the Safety and Performance of a New Beamformer for MED-EL Cochlear Implant Recipien · NA · recruiting
NCT06817928 — Investigating the Performance and Safety of the AudioKey 3, a Device That Provides Remote Control Options and Status Inf · completed
NCT06737185 — Comparison of Speech Understanding Between Tonotopy-based Fitting and Setting Based on Evolutionary Algorithms · NA · recruiting
NCT06723262 — Speech Perception of a Tonotopy-based Fitting for Cochlear Implant Recipients for 6 Months With Conventional Setting · NA · recruiting
NCT05955469 — Comparison in New Cochlear Implanted Subjects of a Tonotopy-based Bimodal Fitting and a Conventional Fitting · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05565339 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by MED-EL Elektromedizinische Geräte GesmbH
Last refreshed: 15 December 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05565339.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing