The Neuro Zti Cochlear Implant System Efficacy and Safety in Adults
1 other identifier
interventional
53
2 countries
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2017
Typical duration for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 18, 2016
CompletedFirst Posted
Study publicly available on registry
October 21, 2016
CompletedStudy Start
First participant enrolled
February 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 22, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 22, 2019
CompletedResults Posted
Study results publicly available
November 10, 2021
CompletedNovember 10, 2021
October 1, 2021
2.8 years
October 18, 2016
April 21, 2020
October 13, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Hearing In Noise Test Score in Quiet (HINT-Q) From Baseline to 6 Months in English-speaking Participants.
To assess the clinical efficiency, speech perception performance using the HINT sentences was measured in quiet at 6 months pos-activation in English speaking participants. Primary clinical efficiency outcome is defined as the change in HINT scores from baseline to 6 months post-activation. Recorded HINT sentences lists were presented to the participant at 60 dB SPL (sound pressure level) pre-operatively in the best aided hearing conditions and at 6 months in the implanted ear after Neuro Zti implant activation. The post-activation assessment was performed in the implanted ear alone with masked controlateral ear. Resultant score is a percentage of words correctly repeated. Possible scores are range from 0% to 100% words correctly repeated. Change = (6 Months score - Baseline score). A score greater or equal to 10% was considered clinically significant improvement.
pre-operative, 6 Months
Major Related Adverse Event (AE)
Adverse event (AE) is defined as any undesired change from the participant's baseline condition symptom or clinically relevant symptom or disease, regardless of its cause. AEs include complications that are related to the device or clinical procedure, as well as unrelated AE that are not related to the device or the trial procedure. AEs were classified as Major if they corresponded to any of the following criteria: * life-threatening conditions (e.g. meningitis) * require hospitalization * result in permanent disability or damage (e.g. facial nerve paresis) * require revision surgery with or without explantation or re-implantation (e.g. device failure, flap necrosis) * medical events that could not be alleviated by electrode deactivation (e.g. tinnitus, facial nerve stimulation, pain) The co-primary safety endpoint is the major related adverse events rate during the surgery and over the post-surgical period from activation to 12 months post-activation.
12 months
Secondary Outcomes (4)
Clinical Benefit on English-speaking Participants
3, 6 and 12 months
Hearing In Noise Test Score in Quiet (HINT-Q) Pre-operatively, at 3-, 6- and 12-Months on English-speaking Participants
pre-operative, 3, 6 and 12 Months
Hearing In Noise Test Score in Noise (HINT-N) Pre-operatively, at 3-, 6- and 12-Months on English-speaking Participants
pre-operative, 3-, 6- and 12-Months
Minor Adverse Events (AE)
12 months
Study Arms (1)
Neuro Cochlear Implant System study group
EXPERIMENTALAll patients will receive a Neuro Zti implant and fitted with Neuro One sound processor
Interventions
Eligibility Criteria
You may qualify if:
- Adults, eighteen (18) years of age or older.
- Bilateral severe-to-profound sensorineural hearing loss, defined by pure-tone average (PTA) ≥70 dB HL (Hearing Level) at 500, 1000 and 2000 Hz on both ears.
- HINT sentences recognition scores in quiet ≤ 50% correct, in the best-aided listening condition.
- Post-lingual onset of deafness.
- Primary implantation (no re-implantation).
- Up-to-date pneumococcal vaccine.
You may not qualify if:
- Medical conditions that contraindicate undergoing cochlear implant surgery (middle ear diseases i.e. AOM/CSOM (Acute Otitis Media/Chronic Suppurative Otitis Media) , lesions of auditory nerve, pathologies of central auditory pathway, otosclerosis; cochlear malformation i.e. Mondini malformation, cochlear ossification, large vestibular aqueduct).
- Unrealistic expectations regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and medical device.
- Unwillingness or inability of the candidate to comply with all investigational requirements.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oticon Medicallead
Study Sites (6)
Nova Scotia Hearing and Speech centres
Halifax, Canada
Ottawa Civic Hospital
Ottawa, Canada
CHU de Quebec - Université de Laval
Québec, Canada
Royal University Hospital
Saskatoon, Canada
Sunnybrook Hopital
Toronto, Canada
Gentofte Hospital
Copenhagen, Denmark
Related Publications (1)
Schramm D, Chen J, Morris DP, Shoman N, Philippon D, Caye-Thomasen P, Hoen M, Karoui C, Laplante-Levesque A, Gnansia D. Clinical efficiency and safety of the oticon medical neuro cochlear implant system: a multicenter prospective longitudinal study. Expert Rev Med Devices. 2020 Sep;17(9):959-967. doi: 10.1080/17434440.2020.1814741. Epub 2020 Oct 3.
PMID: 32885711RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Research Director
- Organization
- Oticon Medical
Study Officials
- PRINCIPAL INVESTIGATOR
David Schramm, MD
Ottawa Civic Hospital
- PRINCIPAL INVESTIGATOR
Daniel Philippon, MD
CHU de Quebec
- PRINCIPAL INVESTIGATOR
Joseph Chen, MD
Sunnybrook Hospital -Toronto
- PRINCIPAL INVESTIGATOR
Nael Shoman, MD
Royal University Hospital, Saskatoon
- PRINCIPAL INVESTIGATOR
David P. Morris, MD
Nova Scotia Hearing and Speech Centres - Halifax
- PRINCIPAL INVESTIGATOR
Per Cayé Thomasen, MD
Gentofte Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2016
First Posted
October 21, 2016
Study Start
February 2, 2017
Primary Completion
November 22, 2019
Study Completion
November 22, 2019
Last Updated
November 10, 2021
Results First Posted
November 10, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share
The present clinical trial started enrolling in Feb. 2017, therefore it does not contain a data sharing statement or Individual Participant Data sharing statement. Data will be analyzed as patient group data and submitted for peer-reviewed publication.