A pivotal prospective open-label multi-center study of safety and effectiveness of cochlear implantation in an expanded population of adults with bilateral sensorineural hearing loss

Brief description of study

The purpose of this research study is to examine the safety and effectiveness of cochlear implantation (CI) in an expanded population of adults who do not meet the current Food and Drug Administration (FDA) indications. Fifty adults will participate in the study.

The FDA-approved CochlearTM Nucleus® CI systems are designed to provide useful hearing. The system works by converting sound in the environment into electric pulses that stimulate the auditory nerve, allowing the brain to perceive sound. The CochlearTM Nucleus® CI system has implanted and external components. The cochlear implant is surgically implanted under the skin behind the ear. The external components include all commercially approved sound processors, and associated fitting software, accessories, and cables.

For the purposes of this study, the commercially approved Cochlear™ Nucleus® system will be used outside the currently approved indications for use in individuals who have more hearing in one or both ears than the traditional cochlear implant population.


Clinical Study Identifier: s24-00495
Principal Investigator: William H Shapiro.
Other Investigators: J. Thomas Roland Jr., David R Friedmann, Mary S Carroll, George Alexiades, Betsy Bromberg, Mariana Mejia Turnbull, Sean O'Leary McMenomey, Daniel Jethanamest, Lisa Goldin, Alison Jill Rigby.


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