Noninvasive Cochlear Stimulation System

Mayo Clinic

Status: Completed

Conditions: Healthy

Treatments: Device: Cochlear Stimulation System (CSS)

Study type: Interventional

Funder types: Other

Identifiers

NCT05112809

21-007158

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

- Employee of Mayo Clinic.

Exclusion criteria

• Pregnant.
• Cochlear implants.
• History of fluctuating sensorineural hearing loss.
• Skin diseases of the head.
• History of acute paroxysmal tachycardia.
• History of trigeminal neuralgia.
• Recent of paralysis of the facial nerve.
• Recent cerebrovascular stroke.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 3 patient groups

Normal hearing subjects

Experimental group

Description:

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

Treatment:

Device: Cochlear Stimulation System (CSS)

Bilateral hearing impaired

Experimental group

Description:

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

Treatment:

Device: Cochlear Stimulation System (CSS)

Asymmetrical hearing-impaired

Experimental group

Description:

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

Treatment:

Device: Cochlear Stimulation System (CSS)