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Article History

Received: 27 June 2023

Accepted: 26 December 2023

First Online: 4 January 2024

Declarations

:

: The study was conducted in accordance with the ethical principles that have their origin in the most recent version of the Declaration of Helsinki (2013 or later), the EN ISO 14155:2011 and any regional or national regulations, as appropriate. The study is registered on ClinicalTrials.gov n°NCT03072862 (7 March 2017).All experimental protocols were approved by the Comitato Etico (AVEN) Area Vasta Emilia Nord, Segreteria locale A.USL Piacenza, Ufficio Protocollo, Via Antonio Anguissola 15, 29121 Piacenza.Each clinic also obtained their own applicable country specific Ethics Committee (EC) Approval/Opinion and Competent Authorities (CA) were notified in France and Italy for participation in the study prior to enrolling the first subjects locally.Written informed consent was obtained from all the participants before the study commenced.

: Not applicable.

: P. G. is a consultant writer for Cochlear Ltd., Advanced Bionics, and MED EL, C. J. J. and G. S. are employees of Cochlear Ltd, P.L.G.is a consultant statistician for Cochlear Ltd. All other authors do not have any competing interest.