Clinical trial NCT02941627: The Neuro Zti Cochlear Implant System Efficacy and Safety in Adults
Official title: The Neuro Zti Cochlear Implant System Efficacy and Safety in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss, Sensorineural
Hearing Loss, Cochlear
Deafness
Keywords: Hearing Loss
Cochlear Implant surgery
Otorhinolaryngology
Oticon Medical
Neuro Cochlear Implant System
Lead sponsor: Oticon Medical
Sponsor class: INDUSTRY
First posted: 2016-10-21
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion criteria

* 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.

Exclusion criteria

* 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.

Primary outcomes:
measure: Change in Hearing In Noise Test Score in Quiet (HINT-Q) From Baseline to 6 Months in English-speaking Participants.
timeFrame: pre-operative, 6 Months
measure: Major Related Adverse Event (AE)
timeFrame: 12 months
Secondary outcomes:
measure: Clinical Benefit on English-speaking Participants
timeFrame: 3, 6 and 12 months
measure: Hearing In Noise Test Score in Quiet (HINT-Q) Pre-operatively, at 3-, 6- and 12-Months on English-speaking Participants
timeFrame: pre-operative, 3, 6 and 12 Months
measure: Hearing In Noise Test Score in Noise (HINT-N) Pre-operatively, at 3-, 6- and 12-Months on English-speaking Participants
timeFrame: pre-operative, 3-, 6- and 12-Months
measure: Minor Adverse Events (AE)
timeFrame: 12 months
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Nova Scotia Hearing and Speech centres
city: Ottawa
country: Canada
facility: Ottawa Civic Hospital
city: Québec
country: Canada
facility: CHU de Quebec - Université de Laval
city: Saskatoon
country: Canada
facility: Royal University Hospital
city: Toronto
country: Canada
facility: Sunnybrook Hopital
city: Copenhagen
country: Denmark
facility: Gentofte Hospital
Study officials:
affiliation: Ottawa Civic Hospital
name: David Schramm, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de Quebec
name: Daniel Philippon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sunnybrook Hospital -Toronto
name: Joseph Chen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal University Hospital, Saskatoon
name: Nael Shoman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nova Scotia Hearing and Speech Centres - Halifax
name: David P. Morris, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gentofte Hospital
name: Per Cayé Thomasen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.