Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2025-12-25 @ 5:06 AM
NCT ID:
NCT02941627
Brief 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.
Detailed 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:
NCT02941627
Study Brief:
Protocol Section:
NCT02941627