Heuninck, Emilie http://orcid.org/0000-0002-4906-3921
Van de Heyning, Paul
Van Rompaey, Vincent
Mertens, Griet
Topsakal, Vedat
Article History
Received: 23 November 2022
Accepted: 3 April 2023
First Online: 12 April 2023
Declarations
:
: The authors declare that there is no conflict of interest.
: The EAR2OS study was registered at clinical trials.gov under identifier NCT03746613 and HEARO device exemption number 80M0763 from the Federal Agency for Medicines and Health Products (FAMHP). The approval of the Antwerp University Hospital ethics committee was granted with number B300201837507. A follow-up study (ARCI25) was registered at clinicaltrails.gov under identifier NCT04102215. The approval of the Antwerp University Hospital ethics committee was granted with number B300201941457 and HEARO device exemption 80M0793.
: All participants gave written informed consent prior to participation in accordance with the Declaration of Helsinki.