Clinical trial NCT05154188: Post Approval Study to Assure the ContInued saFety and effectIveness of Neuro Cochlear Implant System in Adult Users
Official title: Post Approval Study to Assure the ContInued saFety and effectIveness of Neuro Cochlear Implant System in Adult Users
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
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
Lead sponsor: Oticon Medical
Sponsor class: INDUSTRY
First posted: 2021-12-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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).

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).

Eligibility criteria: Inclusion Criteria:

* 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 _

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Stability of improvement of speech perception performance at 12- and 36-months post-activation with AzBio sentence scores.
timeFrame: At 12- and 36-months post-activation (visit 9 and visit 11)
measure: Safety outcome
timeFrame: From Visit 1(8- 12 weeks pre-surgery) to Visit 12 (36 Months post-activation)
Secondary outcomes:
measure: Stability of improvement of speech perception performance at 12- and 36-months post-activation with CNC-words scores.
timeFrame: At 12- and 36-months post-activation (visit 9 & visit 12)
measure: Stability of outcomes over time using AzBio Sentence scores at 1 month in Quiet.
timeFrame: At 1 month post-activation (Visit 6)
measure: Stability of outcomes over time using AzBio sentences in Quiet and Noise at 3- ; 6- and 24-months post-activation
timeFrame: at 3 months(visit 7), 6 months (visit 9) and 24 months (visit 11)
measure: Stability of outcomes over time using CNC word scores at 3-, 6- and 24-months
timeFrame: At 3 months(visit 7), 6 months (visit 9) and 24 months (visit 11)
measure: Stability of outcomes over time for patients under a bimodal condition (i.e., patient wearing a contralateral hearing aid).
timeFrame: At 3-months post activation (visit 7) and 12 months (visit 9)
measure: Longitudinal measures of patient reported outcomes in a newly-implanted population
timeFrame: At 6-,12-,24- and 36 months post-activation (Visits 8,9,11,12)
measure: Longitudinal measures of cognitive abilities in a newly implanted population
timeFrame: At 12-24 and 36 months post-activation (Visits 9,11,12)
measure: Longitudinal programming parameters (T- and C- levels)
timeFrame: At activation (Visit 5), then from 3 months post-activation (V7) throught study completion (an average of 3 years post activation)
measure: Longitudinal device functionality measures (impedances)
timeFrame: At activation (Visit 5), then from 3 months post-activation (V7) throught study completion (an average of 3 years post activation)
measure: Pedictors of outcomes: Electrode impedances collected at all intervals
timeFrame: 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)
measure: Pedictors of outcomes: eCAP responses collected in the operating room
timeFrame: From activation (visit 5) throught study completion (an average of 3 years post activation)
measure: Proportion of major postsurgical complications and AEs over time
timeFrame: At surgery visit (i.e. visit 3, baseline visit, )
Other outcomes:
Locations:
Study officials:
References: