The Neuro Zti Cochlear Implant System Efficacy and Safety in Adults
NCT ID: NCT02941627
Last Updated: 2021-11-10
Study Results
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View full resultsBasic Information
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COMPLETED
NA
53 participants
INTERVENTIONAL
2017-02-02
2019-11-22
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Neuro Cochlear Implant System study group
All patients will receive a Neuro Zti implant and fitted with Neuro One sound processor
Neuro Zti
Cochlear implant
Neuro One
Sound processor
Interventions
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Neuro Zti
Cochlear implant
Neuro One
Sound processor
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Oticon Medical
INDUSTRY
Responsible Party
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Principal Investigators
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David Schramm, MD
Role: PRINCIPAL_INVESTIGATOR
Ottawa Civic Hospital
Daniel Philippon, MD
Role: PRINCIPAL_INVESTIGATOR
CHU de Quebec
Joseph Chen, MD
Role: PRINCIPAL_INVESTIGATOR
Sunnybrook Hospital -Toronto
Nael Shoman, MD
Role: PRINCIPAL_INVESTIGATOR
Royal University Hospital, Saskatoon
David P. Morris, MD
Role: PRINCIPAL_INVESTIGATOR
Nova Scotia Hearing and Speech Centres - Halifax
Per Cayé Thomasen, MD
Role: PRINCIPAL_INVESTIGATOR
Gentofte Hospital
Locations
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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
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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oticon medical website
Other Identifiers
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PIC_07
Identifier Type: -
Identifier Source: org_study_id