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Audiol Neurootol. 2018;23(2):105-115. doi: 10.1159/000490878. Epub 2018 Sep 7.

Minimal Reporting Standards for Active Middle Ear Hearing Implants.

Author information

1
Department of Otorhinolaryngology, Hannover Medical School, Hannover, Germany.
2
University Hospital Frankfurt, ENT/Audiological Acoustics, Frankfurt, Germany.
3
Department of ENT, Medical University of Vienna, Vienna, Austria.
4
Department of Otorhinolaryngology, Head and Neck Surgery, University Medical Center Göttingen, Göttingen, Germany.
5
University Hospital, Inselspital Department of ORL, Head and Neck Surgery, Bern, Switzerland.
6
Department of Otorhinolaryngology, Klinikum Wels-Grieskirchen, Wels, Austria.
7
University Clinic St. Poelten, St. Poelten, Austria.
8
Helios Dr. Horst Schmidt Kliniken Wiesbaden, Wiesbaden, Germany.
9
Vivantes Hearing Center, ORL Department Friedrichshain Clinic, Berlin, Germany.
10
Department of Otolaryngology and Head and Neck Surgery, Audiological Acoustics, University of Mainz, Mainz, Germany.
11
Department of Otolaryngology and Head and Neck Surgery, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany.
12
Department of Otorhinolaryngology, Head and Neck Surgery "Otto Koerner", University Medical Center Rostock, Rostock, Germany.
13
Helios Klinikum Hildesheim, Hildesheim, Germany.
14
Department of Otorhinolaryngology, UniversityHospital Zürich, Head and Neck Surgery, Zürich, Switzerland.
15
Department of Otolaryngology, Klinikum Bielefeld, Head and Neck Surgery, Bielefeld, Germany.
16
Department of Otorhinolaryngology, Head and Neck Surgery, University of Freiburg Medical Center, Freiburg, Germany.
17
Clinic for Otorhinolaryngology, Head and Neck Surgery, University Clinic Schleswig Holstein, Campus Lübeck, Lübeck, Germany.

Abstract

There is currently no standardized method for reporting audiological, surgical and subjective outcome measures in clinical trials with active middle ear implants (AMEIs). It is often difficult to compare studies due to data incompatibility and to perform meta-analyses across different centres is almost impossible. A committee of ENT and audiological experts from Germany, Austria and Switzerland decided to address this issue by developing new minimal standards for reporting the outcomes of AMEI clinical trials. The consensus presented here aims to provide a recommendation to enable better inter-study comparability.

KEYWORDS:

Hearing results; Active middle ear implant; Audiogram; Hearing loss; Hearing outcome ; Meta-analysis; Reporting standards; Review

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