Hearing Loss, SensorineuralNCT02941627
The Neuro Zti Cochlear Implant System Efficacy and Safety in Adults
A study testing Neuro Zti and Neuro One in people with Hearing Loss, Sensorineural and Hearing Loss, Cochlear, run by Oticon Medical at 6 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss, Sensorineural, Hearing Loss, Cochlear, Deafness
- What is being tested?
- Neuro Zti and Neuro One
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 2 Feb 2017to 22 Nov 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Canada5 sites
Nova Scotia Hearing and Speech centres
Halifax
Ottawa Civic Hospital
Ottawa
CHU de Quebec - Université de Laval
Québec
Royal University Hospital
Saskatoon
Sunnybrook Hopital
Toronto
About this study
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.
Read the 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.
- Being tested
- Neuro Zti, Neuro One
- Keywords
- Hearing Loss, Cochlear Implant surgery, Otorhinolaryngology, Oticon Medical, Neuro Cochlear Implant System
- Medical subject headings
- Hearing Loss, Sensorineural, Deafness, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuro ZtiDevice
Cochlear implant
Neuro OneDevice
Sound processor
| Study group | Role | What they receive |
|---|---|---|
| Neuro Cochlear Implant System study group | Experimental | All patients will receive a Neuro Zti implant and fitted with Neuro One sound processor Receives: Device: Neuro Zti; Device: Neuro One |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Secondary outcomes (4)
Clinical Benefit on English-speaking Participants
Clinical benefit is defined as the change of HINT scores post-operatively in the implanted ear only with masked contralateral ear and pre-operatively in the best aided conditions. Clinical benefit is measured in quiet and in noise using the Hearing in Noise Test (HINT).
In quiet, HINT sentences lists were presented to the participant at 60 decibel sound pressure level (dB SPL). In noise, the sentences were presented with concurrent background noise at +10 decibel signal-to-noise-ratio (dB SNR), signal level at 65 dB SPL and noise at 55 dB SPL. Resultant score is a percentage of words correctly repeated, possibly ranged from 0% to 100%.
Clinical benefit is computed for each participant. A positive difference of post- and pre-operative HINT scores is considered clinically significant if it exceeded 10 percentage points (pp). A decrease that exceeded 10 pp is considered a clinically significant decrement. A difference of less than 10 pp was considered as no change in performance.
Measured: 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
To assess the clinical efficiency, speech perception performance using the HINT sentences was measured in quiet pre-operatively, 3-, 6- and 12-months pos-activation on English speaking participants.
Secondary clinical efficiency outcome is defined as the mean HINT scores from baseline to 12 months post-activation.
Recorded HINT sentences lists were presented to the participant at 60 dB SPL pre-operatively in the best aided hearing conditions, at -, 6- and 12- months. 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. A higher score is better.
Measured: 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
To assess the clinical efficiency, speech perception performance using the HINT sentences was measured in noise pre-operatively, 3-, 6- and 12-months pos-activation on English speaking participants.
Secondary clinical efficiency outcome is defined as the mean HINT scores from baseline to 12 months post-activation.
Testing open-set sentence recognition with concurrent background noise present at +10 decibel signal-to-ratio (dB SNR) with signal level presented at 65 dB SPL and noise at 55 dB SPL. Recorded HINT sentences lists were presented to the participant in front pre-operatively in the best aided condition and post-operatively in the implanted ear alone with masked contralateral ear. Speech and noise were colocated (S0N0). Resultant score is a percentage of words correct. Possible scores range from 0% to 100% words correctly repeated. A higher score is better.
Measured: pre-operative, 3-, 6- and 12-Months
Minor Adverse Events (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 Minor if they corresponded to any of the following criteria:
- adverse event settled spontaneously without surgical procedure (e.g. hematoma)
- adverse event settled spontaneously with conservative medical management
The secondary safety endpoint is the minor related adverse events rate during the surgery and over the post-surgical period from activation to 12 months post-activation.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study start2 Feb 2017
- Primary completion22 Nov 2019
- Study completion22 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hearing Loss, SensorineuralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oticon Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Schramm, MD, Principal investigator, Ottawa Civic HospitalDaniel Philippon, MD, Principal investigator, CHU de QuebecJoseph Chen, MD, Principal investigator, Sunnybrook Hospital -TorontoNael Shoman, MD, Principal investigator, Royal University Hospital, SaskatoonDavid P. Morris, MD, Principal investigator, Nova Scotia Hearing and Speech Centres - HalifaxPer Cayé Thomasen, MD, Principal investigator, Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02941627
- Sponsor's protocol ID
- PIC_07
- Status last verified
- Oct 2021
- First submitted
- 18 Oct 2016
- Last updated
- 10 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 32885711
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Neuro Zti Cochlear Implant System Efficacy and Safety in Adults
- ClinicalTrials.gov ID
- NCT02941627
- Acronym / sponsor ID
- PIC_07
- Keywords
- Hearing Loss, Cochlear Implant surgery, Otorhinolaryngology, Oticon Medical, Neuro Cochlear Implant System
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Oticon MedicalIndustry (pharma, biotech, devices)
- Study start
- 2 Feb 2017 (actual)
- Primary completion
- 22 Nov 2019 (actual)
- Study completion
- 22 Nov 2019 (actual)
- First posted
- 21 Oct 2016 (estimated)
- Results
- Posted 10 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neuro Cochlear Implant System study group | Experimental | Device: Neuro Zti, Device: Neuro OneAll patients will receive a Neuro Zti implant and fitted with Neuro One sound processor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuro ZtiCochlear implant | Device | Neuro Cochlear Implant System study group |
| Neuro OneSound processor | Device | Neuro Cochlear Implant System study group |
Primary outcome
Change in Hearing In Noise Test Score in Quiet (HINT-Q) From Baseline to 6 Months in English-speaking Participants.
Time frame: pre-operative, 6 Months
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.
Major Related Adverse Event (AE)
Time frame: 12 months
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.
4 secondary outcomes
Clinical Benefit on English-speaking Participants
Time frame: 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
Time frame: 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
Time frame: pre-operative, 3-, 6- and 12-Months
Minor Adverse Events (AE)
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 32885711Schramm 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.
- oticon medical websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Schramm, MD principal investigator
Ottawa Civic Hospital
Daniel Philippon, MD principal investigator
CHU de Quebec
Joseph Chen, MD principal investigator
Sunnybrook Hospital -Toronto
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuro Zti and Neuro One in people with Hearing Loss, Sensorineural and Hearing Loss, Cochlear, run by Oticon Medical at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hearing In Noise Test Score in Quiet (HINT-Q) From Baseline to 6 Months in English-speaking Participants. (time frame: pre-operative, 6 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02941627, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2021.