Trial Outcomes & Findings for The Neuro Zti Cochlear Implant System Efficacy and Safety in Adults (NCT NCT02941627)
NCT ID: NCT02941627
Last Updated: 2021-11-10
Results Overview
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.
COMPLETED
NA
53 participants
pre-operative, 6 Months
2021-11-10
Participant Flow
Efficacy outcomes will be based on English speaking participants, and safety on overall patients; English, French and Danish speaking participants.
Participant milestones
| Measure |
Neuro Zti/Neuro One Study Group
All patient will receive a Neuro Zti implant and fit with Neuro One sound processor.
|
|---|---|
|
Overall Study
STARTED
|
53
|
|
Overall Study
Clinical Safety on Overall Participants
|
51
|
|
Overall Study
Clinical Efficiency on English Speaking Participants
|
33
|
|
Overall Study
COMPLETED
|
50
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Neuro Zti/Neuro One Study Group
All patient will receive a Neuro Zti implant and fit with Neuro One sound processor.
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Surgical failure
|
1
|
|
Overall Study
cholesteatoma prevented implantation
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Neuro Zti/Neuro One Study Group
n=51 Participants
Neuro Zti: cochlear implant Neuro One: sound processor
All patients will receive a Neuro Zti implant and fit with Neuro One sound processor
|
|---|---|
|
Age, Customized
[18;40] years old
|
1 Participants
n=51 Participants
|
|
Age, Customized
[40;50] years old
|
2 Participants
n=51 Participants
|
|
Age, Customized
[50;60] years old
|
7 Participants
n=51 Participants
|
|
Age, Customized
>=60 years old
|
41 Participants
n=51 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=51 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=51 Participants
|
|
Age at implantation
|
69.5 years
STANDARD_DEVIATION 11.4 • n=51 Participants
|
|
Primary hearing loss etiology
Aging
|
3 Participants
n=51 Participants
|
|
Primary hearing loss etiology
Genetics
|
7 Participants
n=51 Participants
|
|
Primary hearing loss etiology
Noise exposure
|
7 Participants
n=51 Participants
|
|
Primary hearing loss etiology
Menière's disease
|
3 Participants
n=51 Participants
|
|
Primary hearing loss etiology
Other
|
6 Participants
n=51 Participants
|
|
Primary hearing loss etiology
Unknown
|
23 Participants
n=51 Participants
|
|
Primary hearing loss etiology
Otosclerosis
|
1 Participants
n=51 Participants
|
|
Primary hearing loss etiology
Viral
|
1 Participants
n=51 Participants
|
|
Implanted ear (side)
Left
|
22 participants
n=51 Participants
|
|
Implanted ear (side)
Right
|
29 participants
n=51 Participants
|
|
Duration of hearing loss
Implanted ear
|
30.7 years
STANDARD_DEVIATION 19.0 • n=51 Participants
|
|
Duration of hearing loss
Contralateral ear
|
33.2 years
STANDARD_DEVIATION 19.6 • n=51 Participants
|
|
Duration of hearing aid use
Implanted ear
|
22.2 years
STANDARD_DEVIATION 15.8 • n=51 Participants
|
|
Duration of hearing aid use
Contralateral ear
|
22.6 years
STANDARD_DEVIATION 15.8 • n=51 Participants
|
|
PTA (Pure Tone Average), 500 Hz to 2000 Hz
Implanted ear
|
101.3 dB HL
STANDARD_DEVIATION 13.3 • n=51 Participants
|
|
PTA (Pure Tone Average), 500 Hz to 2000 Hz
Contralateral ear
|
95.8 dB HL
STANDARD_DEVIATION 16.3 • n=51 Participants
|
PRIMARY outcome
Timeframe: pre-operative, 6 MonthsPopulation: Clinical efficiency is reported on the thirty-three (33) 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.
Outcome measures
| Measure |
Neuro Zti/Neuro One English-Speaking Participants - 6 Months
n=33 Participants
Neuro Zti: cochlear implant Neuro One: sound processor
All patients received a Neuro Zti implant and fitted with Neuro One sound processor
|
Neuro Zti/Neuro One English-speaking Participants 6 Months
Neuro Zti: cochlear implant Neuro One: sound processor
All patients received a Neuro Zti implant and fitted with Neuro One sound processor
Clinical benefit is assessed in English-speaking participants at 6 months follow-up
|
Neuro Zti/Neuro One English-speaking Participants 12 Months
Neuro Zti: cochlear implant Neuro One: sound processor
All patients received a Neuro Zti implant and fitted with Neuro One sound processor
Clinical benefit is assessed in English-speaking participants at 12 months follow-up
|
|---|---|---|---|
|
Change in Hearing In Noise Test Score in Quiet (HINT-Q) From Baseline to 6 Months in English-speaking Participants.
|
51.5 percent change words correctly repeated
Standard Deviation 33.1
|
—
|
—
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Safety is reported, on overall participants, in terms of surgical safety (intra-operative major complication rate) and post-surgical safety (major complication rate from the surgery to 12 months post activation to determine the long-term safety profile of the Neuro cochlear implant system).
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.
Outcome measures
| Measure |
Neuro Zti/Neuro One English-Speaking Participants - 6 Months
n=71 number of adverse events
Neuro Zti: cochlear implant Neuro One: sound processor
All patients received a Neuro Zti implant and fitted with Neuro One sound processor
|
Neuro Zti/Neuro One English-speaking Participants 6 Months
Neuro Zti: cochlear implant Neuro One: sound processor
All patients received a Neuro Zti implant and fitted with Neuro One sound processor
Clinical benefit is assessed in English-speaking participants at 6 months follow-up
|
Neuro Zti/Neuro One English-speaking Participants 12 Months
Neuro Zti: cochlear implant Neuro One: sound processor
All patients received a Neuro Zti implant and fitted with Neuro One sound processor
Clinical benefit is assessed in English-speaking participants at 12 months follow-up
|
|---|---|---|---|
|
Major Related Adverse Event (AE)
Major device related AE
|
1 number of major adverse events
|
—
|
—
|
|
Major Related Adverse Event (AE)
Major trial procedure related AE
|
1 number of major adverse events
|
—
|
—
|
|
Major Related Adverse Event (AE)
Major unrelated AE
|
2 number of major adverse events
|
—
|
—
|
SECONDARY outcome
Timeframe: 3, 6 and 12 monthsPopulation: Clinical benefit is reported on the 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.
Outcome measures
| Measure |
Neuro Zti/Neuro One English-Speaking Participants - 6 Months
n=33 Participants
Neuro Zti: cochlear implant Neuro One: sound processor
All patients received a Neuro Zti implant and fitted with Neuro One sound processor
|
Neuro Zti/Neuro One English-speaking Participants 6 Months
n=33 Participants
Neuro Zti: cochlear implant Neuro One: sound processor
All patients received a Neuro Zti implant and fitted with Neuro One sound processor
Clinical benefit is assessed in English-speaking participants at 6 months follow-up
|
Neuro Zti/Neuro One English-speaking Participants 12 Months
n=33 Participants
Neuro Zti: cochlear implant Neuro One: sound processor
All patients received a Neuro Zti implant and fitted with Neuro One sound processor
Clinical benefit is assessed in English-speaking participants at 12 months follow-up
|
|---|---|---|---|
|
Clinical Benefit on English-speaking Participants
HINT sentences in Quiet (60dB SPL) · Better (> 10 percent points)
|
26 Participants
|
29 Participants
|
30 Participants
|
|
Clinical Benefit on English-speaking Participants
HINT sentences in Quiet (60dB SPL) · Similar (-10 to 10 percent points)
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Clinical Benefit on English-speaking Participants
HINT sentences in Quiet (60dB SPL) · Worse (< -10 percent points)
|
5 Participants
|
1 Participants
|
1 Participants
|
|
Clinical Benefit on English-speaking Participants
HINT sentences in Noise (+10 dB SNR) · Better (> 10 percent points)
|
22 Participants
|
24 Participants
|
27 Participants
|
|
Clinical Benefit on English-speaking Participants
HINT sentences in Noise (+10 dB SNR) · Similar (-10 to 10 percent points)
|
7 Participants
|
6 Participants
|
6 Participants
|
|
Clinical Benefit on English-speaking Participants
HINT sentences in Noise (+10 dB SNR) · Worse (< -10 percent points)
|
4 Participants
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: pre-operative, 3, 6 and 12 MonthsPopulation: Clinical efficiency is reported on the thirty-three (33) 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.
Outcome measures
| Measure |
Neuro Zti/Neuro One English-Speaking Participants - 6 Months
n=33 Participants
Neuro Zti: cochlear implant Neuro One: sound processor
All patients received a Neuro Zti implant and fitted with Neuro One sound processor
|
Neuro Zti/Neuro One English-speaking Participants 6 Months
Neuro Zti: cochlear implant Neuro One: sound processor
All patients received a Neuro Zti implant and fitted with Neuro One sound processor
Clinical benefit is assessed in English-speaking participants at 6 months follow-up
|
Neuro Zti/Neuro One English-speaking Participants 12 Months
Neuro Zti: cochlear implant Neuro One: sound processor
All patients received a Neuro Zti implant and fitted with Neuro One sound processor
Clinical benefit is assessed in English-speaking participants at 12 months follow-up
|
|---|---|---|---|
|
Hearing In Noise Test Score in Quiet (HINT-Q) Pre-operatively, at 3-, 6- and 12-Months on English-speaking Participants
HINT-Q score at baseline in best aided conditions
|
13.3 percentage of words correctly repeated
Standard Deviation 16.0
|
—
|
—
|
|
Hearing In Noise Test Score in Quiet (HINT-Q) Pre-operatively, at 3-, 6- and 12-Months on English-speaking Participants
HINT-Q score at 3 months in implanted ear
|
55.8 percentage of words correctly repeated
Standard Deviation 31.8
|
—
|
—
|
|
Hearing In Noise Test Score in Quiet (HINT-Q) Pre-operatively, at 3-, 6- and 12-Months on English-speaking Participants
HINT-Q score at 6 months in implanted ear
|
64.8 percentage of words correctly repeated
Standard Deviation 27.2
|
—
|
—
|
|
Hearing In Noise Test Score in Quiet (HINT-Q) Pre-operatively, at 3-, 6- and 12-Months on English-speaking Participants
HINT-Q score at 12 months in implanted ear
|
70.1 percentage of words correctly repeated
Standard Deviation 24.5
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-operative, 3-, 6- and 12-MonthsPopulation: Clinical efficiency is reported on the thirty-three (33) 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.
Outcome measures
| Measure |
Neuro Zti/Neuro One English-Speaking Participants - 6 Months
n=33 Participants
Neuro Zti: cochlear implant Neuro One: sound processor
All patients received a Neuro Zti implant and fitted with Neuro One sound processor
|
Neuro Zti/Neuro One English-speaking Participants 6 Months
Neuro Zti: cochlear implant Neuro One: sound processor
All patients received a Neuro Zti implant and fitted with Neuro One sound processor
Clinical benefit is assessed in English-speaking participants at 6 months follow-up
|
Neuro Zti/Neuro One English-speaking Participants 12 Months
Neuro Zti: cochlear implant Neuro One: sound processor
All patients received a Neuro Zti implant and fitted with Neuro One sound processor
Clinical benefit is assessed in English-speaking participants at 12 months follow-up
|
|---|---|---|---|
|
Hearing In Noise Test Score in Noise (HINT-N) Pre-operatively, at 3-, 6- and 12-Months on English-speaking Participants
HINT-N score at baseline in best aided condition
|
13.3 percentage of words correctly repeated
Standard Deviation 17.7
|
—
|
—
|
|
Hearing In Noise Test Score in Noise (HINT-N) Pre-operatively, at 3-, 6- and 12-Months on English-speaking Participants
HINT-N score at 3 months in implanted ear
|
43.8 percentage of words correctly repeated
Standard Deviation 30.6
|
—
|
—
|
|
Hearing In Noise Test Score in Noise (HINT-N) Pre-operatively, at 3-, 6- and 12-Months on English-speaking Participants
HINT-N score at 6 months in implanted ear
|
52.3 percentage of words correctly repeated
Standard Deviation 30.0
|
—
|
—
|
|
Hearing In Noise Test Score in Noise (HINT-N) Pre-operatively, at 3-, 6- and 12-Months on English-speaking Participants
HINT-N score at 12 months in implanted ear
|
57.6 percentage of words correctly repeated
Standard Deviation 29.9
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Safety is reported, on overall participants, in terms of surgical safety (intra-operative minor complication rate) and post-surgical safety (minor complication rate from the surgery to 12 months post activation to determine the long-term safety profile of the Neuro cochlear implant system).
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.
Outcome measures
| Measure |
Neuro Zti/Neuro One English-Speaking Participants - 6 Months
n=71 number of adverse events
Neuro Zti: cochlear implant Neuro One: sound processor
All patients received a Neuro Zti implant and fitted with Neuro One sound processor
|
Neuro Zti/Neuro One English-speaking Participants 6 Months
Neuro Zti: cochlear implant Neuro One: sound processor
All patients received a Neuro Zti implant and fitted with Neuro One sound processor
Clinical benefit is assessed in English-speaking participants at 6 months follow-up
|
Neuro Zti/Neuro One English-speaking Participants 12 Months
Neuro Zti: cochlear implant Neuro One: sound processor
All patients received a Neuro Zti implant and fitted with Neuro One sound processor
Clinical benefit is assessed in English-speaking participants at 12 months follow-up
|
|---|---|---|---|
|
Minor Adverse Events (AE)
Device related AE
|
16 number of minor adverse events
|
—
|
—
|
|
Minor Adverse Events (AE)
Trial procedure related AE
|
20 number of minor adverse events
|
—
|
—
|
|
Minor Adverse Events (AE)
Unrelated AE
|
31 number of minor adverse events
|
—
|
—
|
Adverse Events
Neuro Zti/Neuro One Study Group
Serious adverse events
| Measure |
Neuro Zti/Neuro One Study Group
n=51 participants at risk
Neuro Zti: implant Neuro One: sound processor All patient will receive a Neuro Zti implant and fit with Neuro One sound processor.
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diagnosis of Liver Cancer
|
2.0%
1/51 • From the participant's cochlear implant surgery initiation to the end of month 12.
Safety Analysis was based on participants for whom the surgery for cochlear implantation was initiated. Among 53 patients enrolled: 1 died for heart stroke after the informed consent process, 1 was not implanted for surgical failure, and 1 for cholesteatoma discovered during surgical procedure. This patient was included in safety analysis as defined in the protocol. Then, among 53 patients enrolled 51 were evaluated for safety outcomes, 50 were successfully implanted and complete the study.
|
|
Renal and urinary disorders
Kidney failure
|
2.0%
1/51 • From the participant's cochlear implant surgery initiation to the end of month 12.
Safety Analysis was based on participants for whom the surgery for cochlear implantation was initiated. Among 53 patients enrolled: 1 died for heart stroke after the informed consent process, 1 was not implanted for surgical failure, and 1 for cholesteatoma discovered during surgical procedure. This patient was included in safety analysis as defined in the protocol. Then, among 53 patients enrolled 51 were evaluated for safety outcomes, 50 were successfully implanted and complete the study.
|
|
Infections and infestations
Exacerbation of COPD
|
2.0%
1/51 • From the participant's cochlear implant surgery initiation to the end of month 12.
Safety Analysis was based on participants for whom the surgery for cochlear implantation was initiated. Among 53 patients enrolled: 1 died for heart stroke after the informed consent process, 1 was not implanted for surgical failure, and 1 for cholesteatoma discovered during surgical procedure. This patient was included in safety analysis as defined in the protocol. Then, among 53 patients enrolled 51 were evaluated for safety outcomes, 50 were successfully implanted and complete the study.
|
Other adverse events
| Measure |
Neuro Zti/Neuro One Study Group
n=51 participants at risk
Neuro Zti: implant Neuro One: sound processor All patient will receive a Neuro Zti implant and fit with Neuro One sound processor.
|
|---|---|
|
Ear and labyrinth disorders
Tinnitus
|
7.8%
4/51 • From the participant's cochlear implant surgery initiation to the end of month 12.
Safety Analysis was based on participants for whom the surgery for cochlear implantation was initiated. Among 53 patients enrolled: 1 died for heart stroke after the informed consent process, 1 was not implanted for surgical failure, and 1 for cholesteatoma discovered during surgical procedure. This patient was included in safety analysis as defined in the protocol. Then, among 53 patients enrolled 51 were evaluated for safety outcomes, 50 were successfully implanted and complete the study.
|
|
Injury, poisoning and procedural complications
Post operative dizziness
|
15.7%
8/51 • From the participant's cochlear implant surgery initiation to the end of month 12.
Safety Analysis was based on participants for whom the surgery for cochlear implantation was initiated. Among 53 patients enrolled: 1 died for heart stroke after the informed consent process, 1 was not implanted for surgical failure, and 1 for cholesteatoma discovered during surgical procedure. This patient was included in safety analysis as defined in the protocol. Then, among 53 patients enrolled 51 were evaluated for safety outcomes, 50 were successfully implanted and complete the study.
|
|
Injury, poisoning and procedural complications
Post procedural pain
|
19.6%
10/51 • From the participant's cochlear implant surgery initiation to the end of month 12.
Safety Analysis was based on participants for whom the surgery for cochlear implantation was initiated. Among 53 patients enrolled: 1 died for heart stroke after the informed consent process, 1 was not implanted for surgical failure, and 1 for cholesteatoma discovered during surgical procedure. This patient was included in safety analysis as defined in the protocol. Then, among 53 patients enrolled 51 were evaluated for safety outcomes, 50 were successfully implanted and complete the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee No independent manuscript is submitted for publication until the multicentre manuscript is accepted for publication. PI can publish results from his/her own site after multicentre manuscript is accepted for publication or 18 months after study completion. Independent manuscript must be submitted to Sponsor for review at least 30 days prior to publication. Sponsor can request within the 30-day review period, PI shall delay proposed communication up to 60 days from the date of Sponsor's request.
- Publication restrictions are in place
Restriction type: OTHER