The Neuro Zti Cochlear Implant System Efficacy and Safety in Adults

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Neuro Zti

Neuro One

About this trial

This is an interventional treatment trial for Hearing Loss, Sensorineural focused on measuring Hearing Loss, Cochlear Implant surgery, Otorhinolaryngology, Oticon Medical, Neuro Cochlear Implant System

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Nova Scotia Hearing and Speech centres
Ottawa Civic Hospital
CHU de Quebec - Université de Laval
Royal University Hospital
Sunnybrook Hopital
Gentofte Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neuro Cochlear Implant System study group

Arm Description

All patients will receive a Neuro Zti implant and fitted with Neuro One sound processor

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

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.

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.

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.

Full Information

NCT ID

NCT02941627

First Posted

October 18, 2016

Last Updated

October 13, 2021

Sponsor

Oticon Medical

1. Study Identification

Unique Protocol Identification Number

NCT02941627

Brief Title

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

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

February 2, 2017 (Actual)

Primary Completion Date

November 22, 2019 (Actual)

Study Completion Date

November 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Oticon Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hearing Loss, Sensorineural, Hearing Loss, Cochlear, Deafness

Keywords

Hearing Loss, Cochlear Implant surgery, Otorhinolaryngology, Oticon Medical, Neuro Cochlear Implant System

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

53 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Neuro Cochlear Implant System study group

Arm Type

Experimental

Arm Description

All patients will receive a Neuro Zti implant and fitted with Neuro One sound processor

Intervention Type

Device

Intervention Name(s)

Neuro Zti

Intervention Description

Cochlear implant

Intervention Type

Device

Intervention Name(s)

Neuro One

Intervention Description

Sound processor

Primary Outcome Measure Information:

Title

Change in Hearing In Noise Test Score in Quiet (HINT-Q) From Baseline to 6 Months in English-speaking Participants.

Description

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.

Time Frame

pre-operative, 6 Months

Title

Major Related Adverse Event (AE)

Description

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.

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Clinical Benefit on English-speaking Participants

Description

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.

Time Frame

3, 6 and 12 months

Title

Hearing In Noise Test Score in Quiet (HINT-Q) Pre-operatively, at 3-, 6- and 12-Months on English-speaking Participants

Description

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.

Time Frame

pre-operative, 3, 6 and 12 Months

Title

Hearing In Noise Test Score in Noise (HINT-N) Pre-operatively, at 3-, 6- and 12-Months on English-speaking Participants

Description

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.

Time Frame

pre-operative, 3-, 6- and 12-Months

Title

Minor Adverse Events (AE)

Description

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.

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

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.

Overall Study Officials: