Cochlear Stimulation System for Hearing Impairment

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Pregnant, Cochlear implants, Stroke, others

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

Compensation: Varies

Number of Visits: 1

Duration: Varies per participant

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new wearable headset designed to assist with hearing. The goal is to determine the optimal settings for the Cochlear Stimulation System (CSS) so it can be used in both medical and everyday environments by individuals with hearing impairments or normal hearing. The trial includes three groups: those with normal hearing, those with hearing loss in both ears, and those with hearing loss in one ear. Employees of the Mayo Clinic with hearing loss or normal hearing may qualify for this trial, unless they have certain medical conditions or a cochlear implant. As an unphased trial, this study allows participants to contribute to innovative research that may enhance hearing solutions for many.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Cochlear Stimulation System is safe for individuals with hearing impairment?

Research has shown that cochlear implants are generally safe. They are already used in both children and adults to help with hearing loss. Studies indicate that these implants can reduce tinnitus, a ringing in the ears, for most people. Only a small number of individuals who did not have tinnitus before reported new symptoms after receiving an implant, suggesting that the treatment is well-tolerated.

Cochlear implants have also been used in individuals with different types of hearing loss, including those who can hear in only one ear or have uneven hearing in both ears. These applications support their safety. While there can be risks, such as minor discomfort or dizziness, serious problems are rare.

The Cochlear Stimulation System being tested here is based on similar technology that has been used safely before. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Cochlear Stimulation System (CSS) because it offers a novel way to improve hearing by directly stimulating the cochlea, which is different from traditional hearing aids and cochlear implants that amplify sound or convert it into electrical signals. Unlike current options, CSS aims to provide more precise stimulation of the auditory pathway, potentially leading to clearer and more natural sound perception. This innovative approach could significantly enhance the quality of life for individuals with various types of hearing impairment, offering hope for improved auditory experiences even for those with complex hearing issues like asymmetrical hearing loss.

What evidence suggests that the Cochlear Stimulation System is effective for hearing impairment?

Research shows that cochlear implants can help people hear better. This trial will test the Cochlear Stimulation System (CSS) on different groups. Studies have found that these implants improve sound recognition and speech understanding for adults with hearing loss in one ear (asymmetric hearing loss), which will be evaluated in the asymmetrical hearing-impaired arm of this trial. For those with hearing loss in both ears, using implants in both ears can significantly enhance hearing, as will be assessed in the bilateral hearing-impaired arm. The implants work by directly stimulating the cochlea, the part of the ear that sends sound signals to the brain. This direct approach can lead to better hearing results than traditional hearing aids. Overall, cochlear implants have a strong record of improving hearing for different types of hearing loss. ^{6 7 8 9 10}

Who Is on the Research Team?

Michael J Cevette, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for Mayo Clinic employees who are in good general health. It's not suitable for those with facial nerve paralysis, skin conditions on the head, a history of certain neurological or cardiac issues, recent stroke, cochlear implants, or fluctuating hearing loss.

Inclusion Criteria

Employee of Mayo Clinic

Exclusion Criteria

Recent of paralysis of the facial nerve

Cochlear implants

My hearing loss comes and goes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

Participants undergo baseline assessments including perception threshold and speech intelligibility tests

Approximately 2 hours

1 visit (in-person)

Treatment

Participants receive cochlear stimulation using the portable wearable hardware headset

Varies per participant

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cochlear Stimulation System (CSS)

Trial Overview Researchers are testing a new Cochlear Stimulation System (CSS), which is a wearable headset designed to help people with hearing impairments. The study aims to find the best settings for this device to be used both medically and by consumers.

How Is the Trial Designed?

Group I: Normal hearing subjects Experimental Treatment 1 Intervention

Subjects with normal hearing will have a standard hearing test utilizing the cochlear stimulation system.

Group II: Bilateral hearing impaired Experimental Treatment 1 Intervention

Subjects with bilateral hearing impairment will have a standard hearing test utilizing the cochlear stimulation system.

Group III: Asymmetrical hearing-impaired Experimental Treatment 1 Intervention

Subjects with asymmetrical hearing-impairment will have a standard hearing test utilizing the cochlear stimulation system.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10440208/

Asymmetric Hearing Loss in Adult Cochlear Implant ... A multi-site clinical trial was conducted to obtain cochlear implant (CI) efficacy data in adults with asymmetric hearing loss (AHL)

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7586262/

Cochlear Implantation in Cases of Asymmetric Hearing Loss A prospective clinical trial evaluated the effectiveness of cochlear implantation in adults with asymmetric hearing loss (AHL).

3. nature.com nature.com/articles/s41598-025-01158-0

Outcomes and prognostic factors in prelingually ... This study aims to investigate the impact of cerebral white matter lesions (CWMLs) on auditory, speech, and non-verbal cognitive (NVC) outcomes following ...

4. tandfonline.com tandfonline.com/doi/full/10.1080/14670100.2025.2516932

The benefit of bilateral cochlear implants in adults with ... CIs are used in patients with sensorineural hearing loss (SNHL), which is caused by dysfunction of the inner ear and/or hearing nerve (Zahnert, ...

5. journals.sagepub.com journals.sagepub.com/doi/10.1177/00368504251386315

The effect of cochlear implantation in patients with ... Evaluation of long-term cochlear implant use in subjects with acquired unilateral profound hearing loss: focus on binaural auditory outcomes.

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf/P000025S104B.pdf

FDA - Summary of Safety and Effectiveness Data (SSED) Cochlear implants are already used for the treatment of children aged 12 months and older with bilateral sensorineural hearing loss. The risk ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3383437/

Cochlear Implantation in Adults with Asymmetric Hearing ... Patients with asymmetric hearing loss who are not typical cochlear implant candidates can benefit from using a cochlear implant in the poorer ear.

8. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf/P970051S205B.pdf

Summary of Safety and Effectiveness Data (SSED) The Cochlear Nucleus 24 Cochlear Implant System is indicated for individuals with unilateral hearing loss who meet the following criteria: • ...

9. nature.com nature.com/articles/s43856-024-00692-8

A prospective cohort study of cochlear implantation as ... We found that cochlear implantation reduces tinnitus in 90% of those with pre-surgical tinnitus whilst causing tinnitus in only 3.4% of those without pre- ...

10. clinicaltrials.gov clinicaltrials.gov/study/NCT03052920

Cochlear Implantation in Adults With Asymmetric Hearing ... This longitudinal study evaluates the possible benefit of cochlear implantation in the poor ear of adults with asymmetric hearing loss.