Clinical efficiency and safety of the oticon medical neuro cochlear implant system: a multicenter prospective longitudinal study

David Schramm, Joseph Chen, David P. Morris, Nael Shoman, Daniel Philippon, Per Cayé-Thomasen, Michel Hoen, Chadlia Karoui, Ariane Laplante-Lévesque, Dan Gnansia

Résultat de recherche: Articleexamen par les pairs

9 Citations (Scopus)

Résumé

Objective: This prospective longitudinal cohort study at six tertiary referral centers in Canada and Denmark describes the clinical efficiency and surgical safety of cochlear implantation with the Oticon Medical Neuro cochlear implant system, including the Neuro Zti implant, the EVO electrode array, and the Neuro One sound processor. Methods: Patients were adult cochlear implant candidates with bilateral sensorineural hearing loss. Results: The mean HINT scores in quiet pre-operatively and at 3, 6, and 12 months post-activation were 13%, 58%, 67%, and 72%, respectively, and in noise (+10 dB SNR) 13%, 46%, 53%, and 59%, respectively. The mean improvement from baseline to 6 months post-activation was 54% in quiet and 40% in noise. The surgical major complication incidence rate was 0% and the post-surgical major complication incidence rate (until 12 months post-activation) was 4%. There was no adverse event that was fatal, that required explantation, or that resulted in sound processor nonuse, and no implant failure. Conclusion: Cochlear implantation with the Oticon Medical Neuro system enables speech identification both in quiet and in noise and audiologic outcomes continue to improve in the year following activation. No substantial adverse events occurred during the surgical implantation procedure and during the 12 months post-activation.

Langue d'origineEnglish
Pages (de-à)959-967
Nombre de pages9
JournalExpert Review of Medical Devices
Volume17
Numéro de publication9
DOI
Statut de publicationPublished - sept. 2020

Note bibliographique

Publisher Copyright:
© 2020 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.

ASJC Scopus Subject Areas

  • Surgery
  • Biomedical Engineering

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