Noninvasive Cochlear Stimulation System

December 9, 2025 updated by: Gaurav N. Pradhan, Mayo Clinic
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic in Arizona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 55 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Normal hearing subjects
Subjects with normal hearing will have a standard hearing test utilizing the cochlear stimulation system.
Device: Cochlear Stimulation System (CSS)
Cochlear stimulation with surround sound and noise cancellation
Experimental: Bilateral hearing impaired
Subjects with bilateral hearing impairment will have a standard hearing test utilizing the cochlear stimulation system.
Device: Cochlear Stimulation System (CSS)
Cochlear stimulation with surround sound and noise cancellation
Experimental: Asymmetrical hearing-impaired
Subjects with asymmetrical hearing-impairment will have a standard hearing test utilizing the cochlear stimulation system.
Device: Cochlear Stimulation System (CSS)
Cochlear stimulation with surround sound and noise cancellation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change in Electric Current Subjects Indicated They Could Hear a Tone at Certain Frequencies
Time Frame: Baseline, approximately 2 hours
Evaluated by increasing the amplitude of the current input until the subject could hear a tone at 250 Hz, 500 Hz, 1,000 Hz, 2,000 Hz, 4,000 Hz, 8,000 Hz, 10,000 Hz, 12,500 Hz and 16,000 Hz. The mean electric current is reported in Milliampere (mA).
Baseline, approximately 2 hours
Speech Intelligibility in Quiet Environment
Time Frame: Baseline, approximately 2 hours
Measured using the modified rhyme test (MRT) consisting of a set of 50 six-item wordlist. Each word list contains single syllable words with a consonant-vowel-consonant sound sequence. Subjects completed electrical word recognition testing in a quiet environment. Electrodes were placed at 3 unique locations (forehead, mastoid, neck) to measure how well speech could be delivered to the subject through the skin electrodes in a manner that would allow subjects to recognize words in a quiet environment. There were 2 experiments done for speech intelligibility. The first involved 20 subjects (outcome 2) and aimed to assess speech intelligibility performance in a basic, quiet environment without background noise. This phase focused on evaluating the fundamental hearing performance. Once it was established that speech intelligibility was satisfactory with electrical stimulation, we proceeded to test an additional 30 subjects in both quiet and noisy environments (outcome 3).
Baseline, approximately 2 hours
Speech Intelligibility in Quiet and Noisy Environments
Time Frame: Baseline; approximately 2 hours
Measured using the modified rhyme test (MRT) consisting of a set of 50 six-item wordlist. Each word list contains single syllable words with a consonant-vowel-consonant sound sequence. Subjects completed electrical word recognition testing in a quiet, then a noisy environment. Electrodes were placed at 3 unique locations (mastoid, wrist, back) to measure how well speech could be delivered to the subject through the skin electrodes in a manner that would allow subjects to recognize words in a quiet and noisy environment. There were 2 experiments done for speech intelligibility. The first involved 20 subjects (outcome2) and aimed to assess speech intelligibility performance in a basic, quiet environment without background noise. This phase focused on evaluating the fundamental hearing performance. Once it was established that speech intelligibility was satisfactory with electrical stimulation, we proceeded to test an additional 30 subjects in both quiet and noisy environments (outcome3)
Baseline; approximately 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Michael J Cevette, PhD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 6, 2023

Primary Completion (Actual)

December 20, 2024

Study Completion (Actual)

February 6, 2025

Study Registration Dates

First Submitted

October 28, 2021

First Submitted That Met QC Criteria

October 28, 2021

First Posted (Actual)

November 9, 2021

Study Record Updates

Last Update Posted (Actual)

December 30, 2025

Last Update Submitted That Met QC Criteria

December 9, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 21-007158

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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