NCT02941627

The Neuro Zti Cochlear Implant System Efficacy and Safety in Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Oticon Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hearing Loss, Sensorineural
• Hearing Loss, Cochlear
• Deafness

Interventions

Type	Name	Description
DEVICE	Neuro Zti	Cochlear implant
DEVICE	Neuro One	Sound processor

Timeline

• Start date: 2017-02-02
• Primary completion: 2019-11-22
• Completion: 2019-11-22
• First posted: 2016-10-21
• Last updated: 2021-11-10
• Results posted: 2021-11-10

Locations

6 sites across 2 countries: Canada, Denmark