Noninvasive Cochlear Stimulation System

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.

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Key information

Conditions

Healthy

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cochlear Stimulation System (CSS)

Device

Cochlear stimulation with surround sound and noise cancellation

Primary outcomes

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).
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).
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)

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2025
First posted: Nov 9, 2021
Registry last updated: Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed