The Neuro Zti Cochlear Implant System Efficacy and Safety in Adults

Oticon Medical

Status

Completed

Conditions

Hearing Loss, Cochlear

Deafness

Hearing Loss, Sensorineural

Treatments

Device: Neuro One

Device: Neuro Zti

Study type

Interventional

Funder types

Industry

Identifiers

NCT02941627

PIC_07

Details and patient eligibility

About

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.

Full 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.

Enrollment

53 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.