Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2026-03-02 @ 8:20 AM
Study NCT ID:
NCT02941627
Status:
COMPLETED
Last Update Posted:
2021-11-10
First Post:
2016-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Neuro Zti Cochlear Implant System Efficacy and Safety in Adults
Sponsor:
Oticon Medical
Organization:
Study Overview
Official Title:
The Neuro Zti Cochlear Implant System Efficacy and Safety in Adults
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: