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

98 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this research is to develop a portable wearable hardware headset using a computer-based software that can establish the optimal stimulation parameters appropriate for medical and consumer environments for individuals with hearing impaired and normal hearing individuals.

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+