An observational study in Sensorineural Hearing Loss, Bilateral, Sensorineural Hearing Loss, Severe and Sensorineural Hearing Loss, Profound, sponsored by Oticon Medical. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-28.
Sponsored by Oticon Medical · Observational
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.
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).
346 studies on the registry are indexed under Hearing Loss, Sensorineural; 100 are open to participants now.
This study's planned enrollment of 60 is below the median of 70 across 86 observational studies indexed under Hearing Loss, Sensorineural.
Browse Hearing Loss, Sensorineural studies →Oticon Medical is the lead sponsor of 45 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Also known as: Neuro ZtiCLA implant, Neuro ZtiEVO implant, Neuro 2 Sound Processor, Neuro 2 SP, Neuro Zti
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.
Time frame: 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.
Time frame: From Visit 1(8- 12 weeks pre-surgery) to Visit 12 (36 Months post-activation)
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.
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.
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.
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
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.
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
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.
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).
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.
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
Patient reported outcome (PRO) measures including quality of life, listening effort and tinnitus at 6-,12-,24- and 36 months post-activation
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
Scores on a cognitive assessment at 12-24 and 36 months post-activation
Time frame: 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
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)
Electrode impedances collected at all intervals
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
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
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
Surgeon perception of handling of the Neuro Zti and electrode array as well as information related to surgical technique
Time frame: At surgery visit (i.e. visit 3, baseline visit, )
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2025; primary completion for Feb 2027, 17 months later.
Of 42 observational studies under Hearing Loss, Sensorineural, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 13. This study's planned 17 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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