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.

Study Overview

• Status: Active, not recruiting
• Conditions: Sensorineural Hearing Loss; Sensorineural Hearing Loss (Disorder); Sensorineural Hearing Loss, Bilateral; Sensorineural Hearing Loss, Severe; Sensorineural Hearing Loss, Profound; Sensori-Neural Deafness
• Intervention / Treatment: Device: Acclaim Cochlear Implant

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85718
      • Center for Neurosciences Ear and Hearing Center
  • California
    • Seal Beach, California, United States, 90740
      • Shohet Ear Associates
  • Florida
    • Gainesville, Florida, United States, 32607
      • University of Florida Health
  • Minnesota
    • Rochester, Minnesota, United States, 55902
      • Mayo Clinic
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73114
      • Hearts for Hearing
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • MUSC Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acclaim CI; Participants who receive the Acclaim CI, or who have the implant procedure attempted.	Device: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
In the Safety Set, frequency and severity of device and procedure related adverse events, including device deficiencies, reported through 12-Month post-activation	From consent to the 1-year follow-up visit
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	From consent to the 1-year follow-up visit

Collaborators and Investigators

• Sponsor: Envoy Medical Corporation

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: November 19, 2024
• First Submitted That Met QC Criteria: November 19, 2024
• First Posted (Actual): November 21, 2024

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: cochlear implant; fully implanted hearing device
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Loss; Hearing Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hearing Loss, Sensorineural
• Other Study ID Numbers: A200

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No