Pivotal Clinical Trial Evaluating the Safety and Efficacy of the Fully Implanted Acclaim Cochlear Implant
NCT ID: NCT06699797
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
56 participants
INTERVENTIONAL
2025-02-06
2028-01-31
Brief Summary
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* 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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Acclaim CI
Participants who receive the Acclaim CI, or who have the implant procedure attempted.
Acclaim Cochlear Implant
Participants with the Acclaim CI device will be tested during follow-up with their hearing results compared to baseline (before the device implant procedure).
Interventions
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Acclaim Cochlear Implant
Participants with the Acclaim CI device will be tested during follow-up with their hearing results compared to baseline (before the device implant procedure).
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Envoy Medical Corporation
INDUSTRY
Responsible Party
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Locations
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Center for Neurosciences Ear and Hearing Center
Tucson, Arizona, United States
Shohet Ear Associates
Seal Beach, California, United States
University of Florida Health
Gainesville, Florida, United States
Mayo Clinic
Rochester, Minnesota, United States
Cleveland Clinic
Cleveland, Ohio, United States
Hearts for Hearing
Oklahoma City, Oklahoma, United States
MUSC Health
Charleston, South Carolina, United States
Countries
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Facility Contacts
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Gwendolyn Clinical Research Nurse
Role: primary
Crystal Clinical Research Director
Role: backup
Clinical Research
Role: primary
D'Lonna Adams
Role: primary
Nicole Tombers, RN
Role: primary
John O'Neil
Role: primary
Sabrina Calise, Research Coordinator
Role: primary
Clinical Research
Role: primary
Other Identifiers
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A200
Identifier Type: -
Identifier Source: org_study_id