Clinical Investigation of the Nucleus® CI532 Cochlear Implant

Cochlear

Status: Completed

Conditions: Hearing Loss

Treatments: Device: Nucleus CI532 cochlear implant

Study type: Interventional

Funder types: Industry

Identifiers

NCT02392403

CLTD5446

Details and patient eligibility

About

The aim of this study is to investigate the clinical benefit for patients implanted with the Nucleus® CI532 cochlear implant and to demonstrate the atraumatic nature of the electrode design.

Nucleus® CI532 has a pre-curved, perimodiolar array, the EA32, which is introduced into the cochlea through a straightening sheath.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Eighteen years of age or older at the time of implantation
• Conventional candidate for cochlear implantation with a perimodiolar electrode array according to local criteria (excepting the exclusion criteria that follow)
• Native speaker in the local language used to assess clinical performance

Exclusion criteria

• Evidence of hearing loss prior to 5 years of age
• Prior cochlear implantation; i.e. having a cochlear implant in the contralateral ear, or previously implanted in either ear
• Medical or psychological conditions that contraindicate undergoing general anaesthesia or surgery
• Ossification, malformation or any other cochlear anomaly, such as common cavity, that might prevent complete insertion of the electrode array, as confirmed by medical examination
• Hearing impairment due to lesion or neuropathy of the acoustic nerve, VIII nerve or central auditory pathway
• Active middle-ear infection
• Tympanic membrane perforation
• Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices
• Unwillingness or inability of the candidate to comply with all investigational requirements such as undergoing a post-operative digital volume tomography/ConeBeam scan
• Patients with existing Cerebral Spinal Fluid shunts or drains, existing perilymph fistula, skull fracture or Cerebral Spinal Fluid leak
• Patients with recurrent episodes of bacterial meningitis
• Pregnancy or breast-feeding
• Known allergies to components of the implant
• Wearing other active implants with known interference with cochlear implants

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Nucleus CI532 cochlear implant

Experimental group

Treatment:

Device: Nucleus CI532 cochlear implant