post approval study to assure the continued safety and effectiveness of neuro cochlear implant system in adult users

Conditions: Sensorineural Hearing Loss, Bilateral; Sensorineural Hearing Loss, Severe; Sensorineural Hearing Loss, Profound

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.

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

Keywords: candidates for a cochlear implantation surgery patients aged 18 years and older