Safety and Efficacy of a Drug Eluting Slim Modiolar Electrode Array

Ki vehet részt

• 18 years or older, at time of consent
• Postlinguistic moderately severe to profound sensorineural hearing loss, defined by a four frequency (500, 1000, 2000, 4000 Hz) pure-tone average unaided threshold (PTA4) ≥ 60 decibels hearing level (dB HL), in the ear to be implanted (For this study, moderately severe is defined by a four-frequency, pure-tone average threshold (PTA4) over the range 500 through 4000 Hz of more than 55 dB HL through 70 dB HL, inclusive. Profound is defined by a PTA4 of more than 90 dB HL)
• Pure-tone average unaided threshold (500 through 4000 Hz) ≥ 30 dB HL, in the contralateral ear
• Preoperative aided word score ≤ 40% correct in the ear to be implanted
• Evidence of pneumococcal vaccination (e.g., Pneumovax) according to local guidelines
• Candidate is proficient in the language used to assess speech perception performance
• Willing and able to provide written informed consent

Ki nem vehet részt

• Middle ear infection (including acute otitis media, chronic otitis media, suppurative otitis media, or serous drainage) in the ear to be implanted either at the time of surgery or within 3 months prior to enrolment
• Presence of a tympanic membrane perforation or a history of otologic surgery within 3 months prior to enrolment, in the ear to be implanted
• Previously reported diagnosis of auditory neuropathy, in the ear to be implanted
• Previously reported diagnosis, in the ear to be implanted, of Large Vestibular Aqueduct Syndrome (LVAS), Meniere's disease, or cochlear hydrops
• Previously reported diagnosis of bacterial meningitis
• Severe, or poorer, bilateral sensorineural hearing loss prior to 5 years of age, as reported by the subject. (For this study, severe is defined by a PTA4 of more than 70 dB HL through 90 dB HL, inclusive)
• Prior cochlear implantation in either ear
• Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations inherent to the surgical procedure(s) and prosthetic devices, as determined by the Investigator
• Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device unless Cochlear sponsored and determined by Investigator or Sponsor to not impact this investigation
• Active autoimmune disease or active immunosuppressive therapy
• Current cerebrospinal fluid (CSF) shunts or drains, existing perilymph fistula, skull fracture or CSF leaks
• Known allergic reaction or contraindication to dexamethasone or corticosteroids
• Medical or psychological conditions that contraindicate general anaesthesia, surgery, or participation in the clinical investigation as determined by the Investigator
• Intra-axial (within the brain) lesions or deafness due to lesions of the acoustic nerve affecting the ear to be implanted
• Ossification, otosclerosis, malformation or any other cochlear anomaly, such as common cavity, that might prevent complete insertion of the electrode array, in the ear to be implanted
• Severe, or poorer, sensorineural hearing loss for more than 20 years, as reported by the subject, in the ear to be implanted
• Medical plan for cochlear implantation during the clinical investigation, contralateral to the ear to be implanted
• Women who are pregnant
• Additional disabilities that may affect the subject's participation or safety during the clinical investigation
• Unable or unwilling to comply with all the requirements of the clinical investigation as determined by the investigator
• Investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as spouse, parent, child, or sibling
• Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation