Acclaim Cochlear Implant for Hearing Loss

Recruiting at 7 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Envoy Medical Corporation

Disqualifiers: Chronic eustachian dysfunction, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

56 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new cochlear implant, the Acclaim CI, to determine if it improves word recognition in adults with severe to profound hearing loss. Researchers aim to assess the implant's safety and identify any side effects following surgery. Participants will undergo implant surgery and attend follow-up visits over two years. The trial seeks adults who became deaf after learning to speak, have used hearing aids for at least 30 days, and still experience significant hearing loss. As an unphased trial, it provides a unique opportunity for participants to contribute to groundbreaking research and potentially enhance their hearing experience.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that the Acclaim CI device is safe for treating severe to profound sensorineural hearing loss in adults?

Research shows that cochlear implants are generally safe and effective for people with severe hearing loss. The Acclaim CI, a new type of fully implanted cochlear implant, is currently under study to assess its safety and effectiveness in helping people hear words.

Early results from studies on the Acclaim CI suggest it can be effective without causing serious harm. However, since testing continues, not all possible side effects are known. The FDA has granted this device "Breakthrough Device Designation," indicating it shows promise and meets an important need.

While cochlear implants have been used safely for many years, participants should know that this specific device is still under study. Researchers will closely monitor trial participants for any medical issues following the implant procedure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Acclaim Cochlear Implant is unique because it is fully implanted, eliminating the need for external components, which traditional cochlear implants typically have. This fully implanted design can offer a more natural hearing experience and reduce the stigma or inconvenience associated with visible devices. Researchers are excited about this treatment because it could improve sound quality and user comfort, potentially leading to better overall satisfaction for individuals with hearing loss.

What evidence suggests that the Acclaim CI device is effective for treating severe to profound sensorineural hearing loss?

Research has shown that the Acclaim Cochlear Implant (CI), which participants in this trial may receive, might help adults with severe to profound hearing loss understand words better. This device is unique because it is fully implanted inside the ear, unlike traditional cochlear implants. Early experiences indicate that the surgery for the Acclaim CI resembles that of traditional implants, with some modifications to accommodate the new design. In earlier studies, patients did not report any serious side effects after using the implant for three months. This suggests that the Acclaim CI could be a promising option for improving hearing in people with significant hearing loss. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

Inclusion Criteria

I have signed the consent form.

I can follow the study's requirements, including surgery and rehab.

I can read, write, and speak English fluently.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implantation

Participants have the Acclaim CI implanted

1 day

1 visit (in-person)

Follow-up

Participants 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

2 years

5 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Acclaim Cochlear Implant

How Is the Trial Designed?

Group I: Acclaim CI Experimental Treatment 1 Intervention

Participants who receive the Acclaim CI, or who have the implant procedure attempted.

Who Is Running the Clinical Trial?

Envoy Medical Corporation

Lead Sponsor

Trials

4

Recruited

280+

Citations

1.

ir.envoymedical.com

ir.envoymedical.com/news-events/press-releases/detail/70/envoy-medical-announces-first-three-patients-enrolled-in-final-stage-of-acclaimr-cochlear-implant-pivotal-clinical-trial

Envoy Medical Announces First Three Patients Enrolled in ...

The Acclaim cochlear implant received Breakthrough Device Designation from the FDA in 2019 and is currently under investigation as part of a ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06699797

Pivotal Clinical Trial Evaluating the Safety and Efficacy of ...

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 ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10532076/

Initial Experiences with the Envoy Acclaim® Fully ...

Implantation with the Acclaim® device is largely similar to a traditional cochlear implant, with modifications to allow room for the implanted ...

4.

sec.gov

sec.gov/Archives/edgar/data/1840877/000121390025096845/ea026049401ex99-1_envoy.htm

Envoy Medical, Inc. Press Release, dated October 7, 2025.

All 10 patients successfully completed their three-month milestone with no serious adverse events (SAEs) or unanticipated device effects (UADEs) ...

5.

mayo.edu

mayo.edu/research/clinical-trials/tests-procedures/cochlear-implants

Cochlear Implants Clinical Trials

The purpose of the study is to evaluate performance of the Acclaim Cochlear Implant System (“System”) and determine what design changes, if any, are required ...

6.

mayo.edu

mayo.edu/research/clinical-trials/cls-20580363

Study of the Fully Implanted Acclaim® Cochlear Implant

The purpose of this study is to demonstrate the safety and efficacy of the fully implanted Acclaim® cochlear implant for the treatment of severe to profound ...