TY - JOUR

T1 - Clinical efficiency and safety of the oticon medical neuro cochlear implant system

T2 - a multicenter prospective longitudinal study

AU - Schramm, David

AU - Chen, Joseph

AU - Morris, David P.

AU - Shoman, Nael

AU - Philippon, Daniel

AU - Cayé-Thomasen, Per

AU - Hoen, Michel

AU - Karoui, Chadlia

AU - Laplante-Lévesque, Ariane

AU - Gnansia, Dan

PY - 2020

Y1 - 2020

N2 - 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.

AB - 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.

KW - Cochlear implant

KW - cochlear implant outcomes

KW - oticon medical neuro cochlear implant system

KW - speech identification

KW - surgical safety

U2 - 10.1080/17434440.2020.1814741

DO - 10.1080/17434440.2020.1814741

M3 - Journal article

C2 - 32885711

AN - SCOPUS:85092127907

VL - 17

SP - 959

EP - 967

JO - Expert Review of Medical Devices

JF - Expert Review of Medical Devices

SN - 1743-4440

IS - 9

ER -