Pivotal Clinical Trial Evaluating the Safety and Efficacy of the Fully Implanted Acclaim Cochlear… (NCT06699797) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Pivotal Clinical Trial Evaluating the Safety and Efficacy of the Fully Implanted Acclaim Cochlear Implant
United States56 participantsStarted 2025-02-06
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
✕. Documented duration of severe to profound hearing loss for 20 or more years.
✕
What they're measuring
1
In the Safety Set, frequency and severity of device and procedure related adverse events, including device deficiencies, reported through 12-Month post-activation
Timeframe: From consent to the 1-year follow-up visit
2
In the Full Analysis Set, within-subject difference between CNC word score obtained at 12-months post-activation in the Acclaim Only condition and the pre-operative aided score in the ear to be implanted
Timeframe: From consent to the 1-year follow-up visit
✕. Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array.
✕. 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.
✕. Known history of chronic eustachian tube dysfunction.
✕. 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.
✕. Hearing loss/disorder of retrocochlear origin.