Pivotal Clinical Trial Evaluating the Safety and Efficacy of the Fully Implanted Acclaim Cochlear Implant

Launched by ENVOY MEDICAL CORPORATION · Nov 19, 2024

Keywords

ClinConnect Summary

This clinical trial is focused on testing a new device called the Acclaim Cochlear Implant (CI) to see if it can help adults with severe to profound sensorineural hearing loss hear better. The main goals are to find out if the Acclaim CI improves how well participants can understand words compared to before they got the implant, and to monitor any medical issues that might arise after the surgery. Participants will receive the Acclaim CI and will need to attend follow-up visits at 1 month, 3 months, 6 months, and then at 1 and 2 years after the device is activated.

To be eligible for this trial, participants must be at least 18 years old, have had significant hearing loss that hasn't improved with hearing aids, and be in good health overall. They should also be able to communicate in English and give their consent to participate. It's important to note that certain conditions, such as having previous cochlear implants or specific ear issues, may prevent someone from joining the study. If selected, participants can expect regular check-ups to assess their hearing progress and any potential side effects from the implant.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Signed and dated informed consent form.
• • 2. Able to understand and comply with the requirements of the Study, including surgery and post-implant rehabilitation.
• • 3. Ability to read, write, comprehend, and speak fluently in English.
• • 4. Post-lingually deafened.
• • 5. 18 years of age or older at the time of informed consent.
• • 6. Good health and absence of significant comorbidities, in the opinion of the Principal Investigator.
• • 7. At least 30 days of experience with appropriate bilaterally fit hearing aids.
• • 8. Ear to be implanted has severe to profound hearing loss defined as pure tone average at 500, 1000, 2000 and 4000 Hz ≥ 70 dB.
• • 9. Contralateral ear has moderately severe to profound hearing loss defined as pure tone average at 500, 1000, 2000 and 4000 Hz ≥ 60 dB.
• • 10. 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.
• • 11. Normal middle ear function based on otoscopy and tympanometry.
• • 12. 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.
• Exclusion Criteria:
• • 1. Documented duration of severe to profound hearing loss for 20 or more years.
• • 2. Previous cochlear implantation in either ear.
• • 3. Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array.
• • 4. Active external or middle ear pathology (i.e., infections, tympanic membrane perforation, or ossicular chain issues) in the ear to be implanted at the time of screening or in the past 6 months, that could impact the proper functioning of the device.
• • 5. Known history of chronic eustachian tube dysfunction.
• • 6. Prior surgery in the middle ear, inner ear, neck, or infraclavicular region which is anticipated to prevent proper placement or function of the Acclaim CI.
• • 7. Hearing loss/disorder of retrocochlear origin.
• • 8. Diagnosis of auditory neuropathy.
• • 9. Currently using other active implants that are expected to interfere with the Acclaim CI position or function.
• • 10. Known hypersensitivity to silicone rubber, polyurethane, stainless steel, titanium, platinum, or gold.
• • 11. Known hypersensitivity or contraindications to procedural or post-procedural medications that cannot be adequately managed medically.
• • 12. Pregnancy at the time of Acclaim CI implantation.
• • 13. Known need for MRI or ionizing radiation treatment during Study participation.
• • 14. Unrealistic expectations on the Participant's part regarding the possible benefits, risks, and limitations inherent to the surgical procedure and use of the Acclaim CI, in the Principal Investigator's opinion.
• • 15. Unwillingness or inability to comply with all investigational requirements.
• • 16. Additional conditions that would prevent completion of all Study requirements, in the opinion of the Principal Investigator.
• • 17. Participation in an investigational drug study or another device study within 3 months of the Screening Visit.
• • 18. Previous history of meningitis.
• 19. Deafness, in the ear to be implanted, due to:
• • 1. a damaged or absent tympanic membrane,
• • 2. a damaged or absent middle ear,
• • 3. an absent cochlea,
• • 4. lesions on the acoustic nerve, or
• • 5. lesions on the central auditory pathway