Sensorineural Hearing Loss, BilateralPACIFICNCT05154188
Post Approval Study to Assure the ContInued saFety and effectIveness of Neuro Cochlear Implant System in Adult Users
An observational study of Sensorineural Hearing Loss, Bilateral and Sensorineural Hearing Loss, Severe, run by Oticon Medical.
Trial summary
On June 23, 2021, the Oticon Medical Neuro Cochlear Implant System (NCIS) was granted premarket approval (PMA) in the US to treat individuals 18 years or older, with bilateral severe-to-profound sensorineural hearing loss, who obtain limited benefit from appropriately fitted hearing aid(s). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sensorineural Hearing Loss, Bilateral, Sensorineural Hearing Loss, Severe, Sensorineural Hearing Loss, Profound
- What is being tested?
- Neuro Cochlear Implant system
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to Feb 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: * The current post-approval study concerning the NCIS will enroll a total of 60 subjects, newly treated. Patients will be regular candidates for a cochlear implantation surgery, according to the indication criteria of the Neuro Cochlear Implant System and the device will be used according to its intended purpose. * 60 subjects must meet the eligibility criteria * The patient can be an existing audiology patient of the CI clinic or can be referred from an outside hearing aid clinic
Who may be able to join
- Individuals 18 years of age or older
- Obtain limited benefit from appropriately fitted hearing aids
- Bilateral severe-to-profound sensorineural hearing loss _ Severe-to-profound hearing loss is determined by a pure-tone average (PTA) superior or equal (≥) to 70 dB HL at 500, 1000 and 2000 Hz. Limited benefit from amplification is defined by scores of 50% or less on a validated sentence recognition test in quiet (AzBio sentences), in the best-aided listening condition _
Who cannot join
- Previous cochlear implantation
- Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array
- Active external or middle ear infections or tympanic membrane perforation in the ear to be implanted
- Presence of medical contraindications to middle-ear or inner-ear surgery or anesthesia as required
- Diagnosis of retro-cochlear pathology
- Diagnosis of auditory neuropathy
Show all 9Show fewer
- Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and use of the prosthetic device
- Unwillingness or inability to comply with all investigational requirements
- Additional cognitive, medical, or social handicaps that would prevent completion of all study requirements
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
On June 23, 2021, the Oticon Medical Neuro Cochlear Implant System (NCIS) was granted premarket approval (PMA) in the US to treat individuals 18 years or older, with bilateral severe-to-profound sensorineural hearing loss, who obtain limited benefit from appropriately fitted hearing aid(s).
To help assure the continued safety and effectiveness of an approved device, a post-approval study was required as a condition of approval under 21 CFR 814.82(a)(2).
The purpose of this study is to provide longer-term data on the safety and effectiveness of the Neuro Cochlear Implant System under general conditions of use in the postmarket environment.
Read the detailed description
The post-approval study will be an open-label, prospective, multi-center, single-arm, non-randomized, self-controlled clinical trial in 10 clinical sites in the US.
The purpose of this study is to provide longer-term data on the safety and effectiveness of the Neuro Cochlear Implant System under general conditions of use in the postmarket environment. This study will be conducted as a prospective, non-controlled, non-randomized study in 10 clinical sites.
A total of 60 subjects, newly treated will be enrolled. Study subjects will be followed for 3 years post implantation of the device with a target follow-up rate of 80% at the end of the study
The primary safety endpoint is the comparison of the type and frequency of adverse events and serious adverse events observed during the study period. The effectiveness endpoints will include the within-subject differences for sentence recognition as evaluated with the AzBio test.
The study will include the following visits: baseline, 1-month post-surgery (activation date), 3 months, 6-months, 12-months, 18-months, 24-months, and 36-months post-activation. Each participant will serve as their own control with baseline measurements.
The total estimated duration of the study is 60 months: 24 months of recruitment and 36 months of subject participation.
The first patient is expected to be included within 6 months of study approval (obtained on August 19, 2021).
- Conditions
- Sensorineural Hearing Loss, Bilateral, Sensorineural Hearing Loss, Severe, Sensorineural Hearing Loss, Profound
- Being tested
- Neuro Cochlear Implant system
- Keywords
- candidates for a cochlear implantation surgery, patients aged 18 years and older
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuro Cochlear Implant systemDevice
Also called Neuro ZtiCLA implant, Neuro ZtiEVO implant, Neuro 2 Sound Processor, Neuro 2 SP
Patients will be regular candidates for a cochlear implantation surgery, according to the indication criteria of the Neuro Cochlear Implant System and the device will be used according to its intended purpose
What is being measured
The primary outcome is the main question the study is designed to answer.
Stability of improvement of speech perception performance at 12- and 36-months post-activation with AzBio sentence scores.
Average scores for AzBio sentence tests will be recorded in Quiet at 12- and 36-months post-activation and compared to pre-operative (baseline) measures.
The AzBio sentence test is a validated sentence recognition test in quiet and has a score range of 0-100% with higher values indicating better scores.
Measured: At 12- and 36-months post-activation (visit 9 and visit 11)
Safety outcome
Occurrence and severity of all adverse events and serious adverse events occuring during the study period. All device failures (internal and external parts) will be documented.
Measured: From Visit 1(8- 12 weeks pre-surgery) to Visit 12 (36 Months post-activation)
Secondary outcomes (12)
Stability of improvement of speech perception performance at 12- and 36-months post-activation with CNC-words scores.
Consonant-Nucleus-Consonant (CNC) scores will be recorded in Quiet at 12- and 36-months post-activation and compared to pre-operative (baseline) measures.
The CNC word test has a score range of 0-100% with higher values indicating better scores.
Measured: At 12- and 36-months post-activation (visit 9 & visit 12)
Stability of outcomes over time using AzBio Sentence scores at 1 month in Quiet.
Scores for AzBio sentence tests will be recorded in Quiet at 1-month post-activation in quiet and compared to pre-operative (baseline) measures.
The AzBio sentence test is a validated sentence recognition test in quiet and has a score range of 0-100% with higher values indicating better scores.
Measured: At 1 month post-activation (Visit 6)
Stability of outcomes over time using AzBio sentences in Quiet and Noise at 3- ; 6- and 24-months post-activation
Average scores for AzBio sentence tests will be recorded in Quiet at 3- ; 6- and 24-months post-activation and compared to pre-operative (baseline) measures.
The AzBio sentence test is a validated sentence recognition test and has a score range of 0-100% with higher values indicating better scores.
Measured: at 3 months(visit 7), 6 months (visit 9) and 24 months (visit 11)
Stability of outcomes over time using CNC word scores at 3-, 6- and 24-months
Average scores for CNC word test will be recorded at 3-, 6- and 24 months post-activation and compared to pre-operative (baseline) measures.
The Consonant-Nucleus-Consonant (CNC) word test has a score range of 0-100% with higher values indicating better scores.
Measured: At 3 months(visit 7), 6 months (visit 9) and 24 months (visit 11)
Stability of outcomes over time for patients under a bimodal condition (i.e., patient wearing a contralateral hearing aid).
Average scores for AzBio sentence tests will be recorded in Noise (at +10dB SNR), at 3- and 12-months post-activation and compared to pre-operative (baseline) measures.
The AzBio sentence test is a validated sentence recognition test and has a score range of 0-100% with higher values indicating better scores.
Measured: At 3-months post activation (visit 7) and 12 months (visit 9)
Longitudinal measures of patient reported outcomes in a newly-implanted population
Patient reported outcome (PRO) measures including quality of life, listening effort and tinnitus at 6-,12-,24- and 36 months post-activation
Measured: At 6-,12-,24- and 36 months post-activation (Visits 8,9,11,12)
Longitudinal measures of cognitive abilities in a newly implanted population
Scores on a cognitive assessment at 12-24 and 36 months post-activation
Measured: At 12-24 and 36 months post-activation (Visits 9,11,12)
Longitudinal programming parameters (T- and C- levels)
T and C levels collected at all intervals
Measured: At activation (Visit 5), then from 3 months post-activation (V7) throught study completion (an average of 3 years post activation)
Longitudinal device functionality measures (impedances)
Electrode impedances collected at all intervals
Measured: At activation (Visit 5), then from 3 months post-activation (V7) throught study completion (an average of 3 years post activation)
Pedictors of outcomes: Electrode impedances collected at all intervals
Electrode impedances collected at all intervals
Measured: At surgery visit (Visit 3 baseline visit) then from activation, 1-month post surgery( visit 5) throught study completion (an average of 3 years post activation)
Pedictors of outcomes: eCAP responses collected in the operating room
eCAP responses collected in the operating room
Measured: From activation (visit 5) throught study completion (an average of 3 years post activation)
Proportion of major postsurgical complications and AEs over time
Surgeon perception of handling of the Neuro Zti and electrode array as well as information related to surgical technique
Measured: At surgery visit (i.e. visit 3, baseline visit, )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start1 Sep 2025 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensorineural Hearing Loss, BilateralStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oticon Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05154188
- Sponsor's protocol ID
- CIP25
- Acronym
- PACIFIC
- Status last verified
- Mar 2024
- First submitted
- 13 Oct 2021
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Approval Study to Assure the ContInued saFety and effectIveness of Neuro Cochlear Implant System in Adult Users
- ClinicalTrials.gov ID
- NCT05154188
- Acronym / sponsor ID
- PACIFIC / CIP25
- Conditions
- Sensorineural Hearing Loss, Bilateral, Sensorineural Hearing Loss, Severe, Sensorineural Hearing Loss, Profound
- Keywords
- candidates for a cochlear implantation surgery, patients aged 18 years and older
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Oticon MedicalIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 13 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
On June 23, 2021, the Oticon Medical Neuro Cochlear Implant System (NCIS) was granted premarket approval (PMA) in the US to treat individuals 18 years or older, with bilateral severe-to-profound sensorineural hearing loss, who obtain limited benefit from appropriately fitted hearing aid(s).
To help assure the continued safety and effectiveness of an approved device, a post-approval study was required as a condition of approval under 21 CFR 814.82(a)(2).
The purpose of this study is to provide longer-term data on the safety and effectiveness of the Neuro Cochlear Implant System under general conditions of use in the postmarket environment.
Detailed description
The post-approval study will be an open-label, prospective, multi-center, single-arm, non-randomized, self-controlled clinical trial in 10 clinical sites in the US.
The purpose of this study is to provide longer-term data on the safety and effectiveness of the Neuro Cochlear Implant System under general conditions of use in the postmarket environment. This study will be conducted as a prospective, non-controlled, non-randomized study in 10 clinical sites.
A total of 60 subjects, newly treated will be enrolled. Study subjects will be followed for 3 years post implantation of the device with a target follow-up rate of 80% at the end of the study
The primary safety endpoint is the comparison of the type and frequency of adverse events and serious adverse events observed during the study period. The effectiveness endpoints will include the within-subject differences for sentence recognition as evaluated with the AzBio test.
The study will include the following visits: baseline, 1-month post-surgery (activation date), 3 months, 6-months, 12-months, 18-months, 24-months, and 36-months post-activation. Each participant will serve as their own control with baseline measurements.
The total estimated duration of the study is 60 months: 24 months of recruitment and 36 months of subject participation.
The first patient is expected to be included within 6 months of study approval (obtained on August 19, 2021).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * The current post-approval study concerning the NCIS will enroll a total of 60 subjects, newly treated. Patients will be regular candidates for a cochlear implantation surgery, according to the indication criteria of the Neuro Cochlear Implant System and the device will be used according to its intended purpose. * 60 subjects must meet the eligibility criteria * The patient can be an existing audiology patient of the CI clinic or can be referred from an outside hearing aid clinic
Key inclusion criteria (3 listed)
- Individuals 18 years of age or older
- Obtain limited benefit from appropriately fitted hearing aids
- Bilateral severe-to-profound sensorineural hearing loss _ Severe-to-profound hearing loss is determined by a pure-tone average (PTA) superior or equal (≥) to 70 dB HL at 500, 1000 and 2000 Hz. Limited benefit from amplification is defined by scores of 50% or less on a validated sentence recognition test in quiet (AzBio sentences), in the best-aided listening condition _
Key exclusion criteria (9 listed)
- Previous cochlear implantation
- Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array
- Active external or middle ear infections or tympanic membrane perforation in the ear to be implanted
- Presence of medical contraindications to middle-ear or inner-ear surgery or anesthesia as required
- Diagnosis of retro-cochlear pathology
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 Cochlear Implant systemAlso: Neuro ZtiCLA implant, Neuro ZtiEVO implant, Neuro 2 Sound Processor, Neuro 2 SPPatients will be regular candidates for a cochlear implantation surgery, according to the indication criteria of the Neuro Cochlear Implant System and the device will be used according to its intended purpose | Device | – |
Primary outcome
Stability of improvement of speech perception performance at 12- and 36-months post-activation with AzBio sentence scores.
Time frame: At 12- and 36-months post-activation (visit 9 and visit 11)
Average scores for AzBio sentence tests will be recorded in Quiet at 12- and 36-months post-activation and compared to pre-operative (baseline) measures. The AzBio sentence test is a validated sentence recognition test in quiet and has a score range of 0-100% with higher values indicating better scores.
Safety outcome
Time frame: From Visit 1(8- 12 weeks pre-surgery) to Visit 12 (36 Months post-activation)
Occurrence and severity of all adverse events and serious adverse events occuring during the study period. All device failures (internal and external parts) will be documented.
12 secondary outcomes
Stability of improvement of speech perception performance at 12- and 36-months post-activation with CNC-words scores.
Time frame: At 12- and 36-months post-activation (visit 9 & visit 12)
Stability of outcomes over time using AzBio Sentence scores at 1 month in Quiet.
Time frame: At 1 month post-activation (Visit 6)
Stability of outcomes over time using AzBio sentences in Quiet and Noise at 3- ; 6- and 24-months post-activation
Time frame: at 3 months(visit 7), 6 months (visit 9) and 24 months (visit 11)
Stability of outcomes over time using CNC word scores at 3-, 6- and 24-months
Time frame: At 3 months(visit 7), 6 months (visit 9) and 24 months (visit 11)
Stability of outcomes over time for patients under a bimodal condition (i.e., patient wearing a contralateral hearing aid).
Time frame: At 3-months post activation (visit 7) and 12 months (visit 9)
Longitudinal measures of patient reported outcomes in a newly-implanted population
Time frame: At 6-,12-,24- and 36 months post-activation (Visits 8,9,11,12)
Longitudinal measures of cognitive abilities in a newly implanted population
Time frame: At 12-24 and 36 months post-activation (Visits 9,11,12)
Longitudinal programming parameters (T- and C- levels)
Time frame: At activation (Visit 5), then from 3 months post-activation (V7) throught study completion (an average of 3 years post activation)
Longitudinal device functionality measures (impedances)
Time frame: At activation (Visit 5), then from 3 months post-activation (V7) throught study completion (an average of 3 years post activation)
Pedictors of outcomes: Electrode impedances collected at all intervals
Time frame: At surgery visit (Visit 3 baseline visit) then from activation, 1-month post surgery( visit 5) throught study completion (an average of 3 years post activation)
Pedictors of outcomes: eCAP responses collected in the operating room
Time frame: From activation (visit 5) throught study completion (an average of 3 years post activation)
Proportion of major postsurgical complications and AEs over time
Time frame: At surgery visit (i.e. visit 3, baseline visit, )
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Sensorineural Hearing Loss, Bilateral and Sensorineural Hearing Loss, Severe, run by Oticon Medical.
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 3 inclusion and 9 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: opening soon, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michel HOEN, PHD (+33679191047, MHOE@oticonmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stability of improvement of speech perception performance at 12- and 36-months post-activation with AzBio sentence scores. (time frame: At 12- and 36-months post-activation (visit 9 and visit 11)). 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?
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 28 Mar 2024.