Clinical Investigation of the Nucleus® CI532 Cochlear Implant

NCT ID: NCT02392403

Last Updated: 2018-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2016-07-31

Brief Summary

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.

Conditions

Hearing Loss

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nucleus CI532 cochlear implant

Group Type: EXPERIMENTAL

Nucleus CI532 cochlear implant

Intervention Type: DEVICE

Interventions

Nucleus CI532 cochlear implant

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Eighteen years of age or older at the time of implantation

Exclusion Criteria

• Native speaker in the local language used to assess clinical performance

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cochlear

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chris J James, PhD

Role: STUDY_DIRECTOR

Cochlear

Locations

The HEARing CRC

Melbourne, Victoria, Australia

Service d' ORL et d'Otoneurochirurgie, CHU Toulouse Purpan

Toulouse, Midi-Pyrénées, France

Ear, Nose and Throat Department, University of Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Ear, Nose and Throat Department, Universitätsklinikum Erlangen

Erlangen, Bavaria, Germany

Klinikum der J. W. Goethe-Universität Frankfurt

Frankfurt am Main, Hesse, Germany

Ear, Nose and Throat Department, Medizinische Hochschule

Hanover, Lower Saxony, Germany

Universitätsklinikum Schleswig-Holstein - Campus Kiel

Kiel, Schleswig-Holstein, Germany

Complejo Hospitalario Universitario Insular Materno Infantil

Las Palmas, Gran Canaria, Spain

Countries

Australia; France; Germany; Spain

References

Hey M, Wesarg T, Mewes A, Helbig S, Hornung J, Lenarz T, Briggs R, Marx M, Ramos A, Stover T, Escude B, James CJ, Aschendorff A. Objective, audiological and quality of life measures with the CI532 slim modiolar electrode. Cochlear Implants Int. 2019 Mar;20(2):80-90. doi: 10.1080/14670100.2018.1544684. Epub 2018 Nov 22.

Reference Type: DERIVED

PMID: 30465637 (View on PubMed)

Other Identifiers

CLTD5446

Identifier Type: -

Identifier Source: org_study_id