Minimal Reporting Standards for Active Middle Ear Hearing Implants

Hannes Maier; Uwe Baumann; Wolf-Dieter Baumgartner; Dirk Beutner; Marco D Caversaccio; Thomas Keintzel; Martin Kompis; Thomas Lenarz; Astrid Magele; Torsten Mewes; Alexander Müller; Tobias Rader; Torsten Rahne; Sebastian P Schraven; Burkard Schwab; Georg Mathias Sprinzl; Bernd Strauchmann; Ingo Todt; Thomas Wesarg; Barbara Wollenberg; Stefan K Plontke

doi:10.1159/000490878

Minimal Reporting Standards for Active Middle Ear Hearing Implants

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

Authors

Hannes Maier¹, Uwe Baumann², Wolf-Dieter Baumgartner³, Dirk Beutner⁴, Marco D Caversaccio⁵, Thomas Keintzel⁶, Martin Kompis⁵, Thomas Lenarz¹, Astrid Magele⁷, Torsten Mewes⁸, Alexander Müller⁹, Tobias Rader¹⁰, Torsten Rahne¹¹, Sebastian P Schraven¹², Burkard Schwab¹³, Georg Mathias Sprinzl⁷, Bernd Strauchmann¹⁴, Ingo Todt¹⁵, Thomas Wesarg¹⁶, Barbara Wollenberg¹⁷, Stefan K Plontke¹¹

Affiliations

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.

The Author(s). Published by S. Karger AG, Basel.

MeSH terms

Austria
Consensus
Germany
Hearing
Hearing Aids*
Hearing Loss, Sensorineural / surgery*
Hearing Tests
Humans
Ossicular Prosthesis*
Outcome Assessment, Health Care / standards*
Switzerland
Treatment Outcome