Clinical Evaluation of the Nucleus 5 Cochlear Implant (CI) System

Cochlear

Status

Completed

Conditions

Hearing Loss

Treatments

Device: Cochlear implantation

Device: Nucleus 5 Cochlear implant

Study type

Interventional

Funder types

Industry

Identifiers

CAM5255

Details and patient eligibility

About

To evaluate the performance of the Nucleus 5 Cochlear Implant System.

Full description

Performance outcomes of newly implanted adult recipients using the Nucleus 5 Cochlear Implant System.

Enrollment

49 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Eighteen years of age or older at the time of the study.
Postlinguistic onset of bilateral severe-to-profound sensorineural hearing loss
Bilateral severe-to-profound hearing loss that meets current cochlear implant criteria (<50% open-set sentence recognition in quiet scores in the ear to be implanted and <60% in the best-aided condition)
English spoken as the primary language.
Willingness to participate in and to comply with all requirements of the study
Subject may receive bilateral simultaneous cochlear implants.

Exclusion criteria

Previous cochlear implant experience
Congenital hearing loss (for the purpose of this study, onset prior to 2 years-of-age).
Ossification, absence of cochlear development or any other cochlear anomaly that might prevent complete insertion of the electrode array.
Normal hearing in one or both ears.
Hearing loss of neural or central origin (e.g., deafness due to lesions on the acoustic nerve or central auditory pathway).
Active middle-ear infection.
Unwillingness and/or inability of the candidate to comply with all investigational requirements including, but not limited to, study protocol and surgical procedure.