Noninvasive Cochlear Stimulation System

NCT ID: NCT05112809

Last Updated: 2025-12-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-06

Study Completion Date

2025-02-06

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Keywords

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Normal hearing

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Normal hearing subjects

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

Group Type EXPERIMENTAL

Cochlear Stimulation System (CSS)

Intervention Type DEVICE

Cochlear stimulation with surround sound and noise cancellation

Bilateral hearing impaired

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

Group Type EXPERIMENTAL

Cochlear Stimulation System (CSS)

Intervention Type DEVICE

Cochlear stimulation with surround sound and noise cancellation

Asymmetrical hearing-impaired

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

Group Type EXPERIMENTAL

Cochlear Stimulation System (CSS)

Intervention Type DEVICE

Cochlear stimulation with surround sound and noise cancellation

Interventions

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Cochlear Stimulation System (CSS)

Cochlear stimulation with surround sound and noise cancellation

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Gaurav N. Pradhan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael J Cevette, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Site Status

Countries

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United States

References

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Kingsbury SE, Cevette MJ, Stepanek J, Pradhan GN. Investigating Speech Intelligibility Capabilities of Electrical Auditory Stimulation. Mil Med. 2025 Sep 3:usaf430. doi: 10.1093/milmed/usaf430. Online ahead of print.

Reference Type DERIVED
PMID: 40899906 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Related Links

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Other Identifiers

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21-007158

Identifier Type: -

Identifier Source: org_study_id