Pivotal Clinical Trial Evaluating the Safety and Efficacy of the Fully Implanted Acclaim Cochlear Implant
The goal of this clinical trial is to learn if the Acclaim CI works to treat severe to profound sensorineural hearing loss in adults. It was also learn about the safety of the Acclaim CI implant. The main questions it aims to answer are: * Does the Acclaim CI device help participants hear words better compared to before the implants? * What medical problems do participants have after the Acclaim CI device was implanted? Participants will: * Have the Acclaim CI implanted; and * Visit the clinical site for checkups and tests at 1-Month, 3-Months, 6-Months, and at 1-year and 2-years after the device has been turned on.
• Signed and dated informed consent form.
• Able to understand and comply with the requirements of the Study, including surgery and post-implant rehabilitation.
• Ability to read, write, comprehend, and speak fluently in English.
• Post-lingually deafened.
• 18 years of age or older at the time of informed consent.
• Good health and absence of significant comorbidities, in the opinion of the Principal Investigator.
• At least 30 days of experience with appropriate bilaterally fit hearing aids.
• Ear to be implanted has severe to profound hearing loss defined as pure tone average at 500, 1000, 2000 and 4000 Hz ≥ 70 dB.
• Contralateral ear has moderately severe to profound hearing loss defined as pure tone average at 500, 1000, 2000 and 4000 Hz ≥ 60 dB.
⁃ Limited benefit from amplification defined as CNC monosyllabic word recognition ≤ 40% in the ear to be implanted and ≤ 60% in the contralateral ear, in the aided condition.
⁃ Normal middle ear function based on otoscopy and tympanometry.
⁃ An accessible cochlear lumen and intact cochlear nerve, and no known lesions on the auditory nerve or auditory central nervous system, on the ear to be implanted confirmed with MRI or CT scan.