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The Neuro Zti Cochlear Implant System Efficacy and Safety in Adults

Hearing Loss, Sensorineural Clinical Trial

Official title:
The Neuro Zti Cochlear Implant System Efficacy and Safety in Adults

Clinical Trial Summary

The purpose of the study is to assess the efficacy and the safety profile of the Neuro Cochlear Implant System (CIS) in adults with severe-to-profound hearing loss.

Clinical Trial Description

Appropriate adult cochlear implant candidates with sensorineural hearing loss, from English French Canadian centres and Danish centre, received Neuro Zti cochlear implant and fit with Neuro One sound processor. Speech perception testing, using HINT (Hearing In Noise Test) sentences in quiet (65 dB SPL) (decibel, Sound Pressure Level) and in noise (+10 dB SNR) (decibel, Signal-to-Noise-Ratio), will be administrated pre-operatively in the best listening conditions and 3, 6, and 12 months post-activation in the implanted ear. Adverse events will be collected during the surgery and over the post-surgical period from activation to12 months post-activation. Safety will be assessed on the overall English, French and Danish participants. Efficacy will be assessed on English speaking participants. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02941627
Study type Interventional
Source Oticon Medical
Contact
Status Completed
Phase N/A
Start date February 2, 2017
Completion date November 22, 2019
View Details
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