PMEI Post-Market Clinical Follow-Up

Conditions

Pre-existing Condition

Keywords

passive middle ear implant

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.

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, Skarżyński PH, Plichta Ł, Hornung J, Taha L, Lenarz T, Busch S, Windisch F, Loader B.

2025-10-15

10.1007/s00405-025-09733-x

Safety and performance of the new med-el total ossicular replacement prostheses

Esther Schimanski, Thomas Lenarz, Susan H. Busch, Susan Arndt, Christian Offergeld et al. (21 authors)

European Archives of Oto-Rhino-Laryngology2024-07-131 citations

10.1007/s00405-024-08784-w

Short-term safety and effectiveness of the mCLIP partial prosthesis.

Rasse 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, Skarżyński PH, Plichta Ł, Arnoldner C, Riss D, Loader B, Windisch F, Rubicz N, Zwittag PM.

2023-12-221 citations

10.1007/s00405-023-08359-1

Interventions

DEVICEPMEIs

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 design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

0 Years to 99 Years

Inclusion criteria

• Inclusion Criteria: Implanted with a MED-EL PMEI; initial implantation or revision implantation receiving a MED-EL PMEI •

Exclusion criteria

None

Design outcomes

Primary

Measure	Time frame	Description
ABG	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

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

Countries

Austria, Germany, Poland

Outcome results

None listed