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Article History

Received: 4 February 2020

Accepted: 24 June 2020

First Online: 23 July 2020

Ethics approval and consent to participate

: Each collaborating clinic has obtained Ethics Committee (EC) Approval/Opinion (or Competent Authority (CA) Approval if applicable) for their participation in the study and has obtained formal local approval prior to enrolling their first subject: comité de Tours – Centre-ouest1 for Paris and Toulouse (2017 T2–17 (2017-A01964–49); Ethics committee Bnai Zion Medical center for Haïfa (0074–17-BNZ); Ethics committee Rabin MC Belinson Hospital for Petah Tikva; Comitato Etico A.USL Di Piacenza (5987/2017); Comitato Etico Clinica della Provincia Di Padova (4295/AO/17); Comité de Etica de la Investigacion del complejo Hospitalario Insular-Materno Infantil de Las Palmas; Comité Etico de Investigacion Clinica de Navarra for Pamplona (EO17/1). Subjects are enrolled into the clinical investigation only after signing the Patient Informed Consent Form prior to the pre-implant assessment. The study is conducted in accordance with the most recent version of the Declaration of Helsinki, the EN ISO 14155:2011 and any regional or national regulations, as appropriate.

: No private information of patients is intended for publication.

: This study is sponsored by the company Cochlear. The results will be interpreted by Cochlear’s own experts in collaboration with the principal investigators.