HealthyNCT05112809

Noninvasive Cochlear Stimulation System

A study testing Cochlear Stimulation System (CSS) in people with Healthy, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 21 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Cochlear Stimulation System (CSS)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 68 participants
Where: 1 siteUnited States
Study dates: 6 Oct 2023to 6 Feb 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Employee of Mayo Clinic.

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic in Arizona
Scottsdale, Arizona, 85259

Other trials in United States

About this study

Conditions: Healthy
Being tested: Cochlear Stimulation System (CSS)
Keywords: Normal hearing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cochlear Stimulation System (CSS)Device
Cochlear stimulation with surround sound and noise cancellation

Study groups in NCT05112809
Study group	Role	What they receive
Normal hearing subjects	Experimental	Subjects with normal hearing will have a standard hearing test utilizing the cochlear stimulation system. Receives: Device: Cochlear Stimulation System (CSS)
Bilateral hearing impaired	Experimental	Subjects with bilateral hearing impairment will have a standard hearing test utilizing the cochlear stimulation system. Receives: Device: Cochlear Stimulation System (CSS)
Asymmetrical hearing-impaired	Experimental	Subjects with asymmetrical hearing-impairment will have a standard hearing test utilizing the cochlear stimulation system. Receives: Device: Cochlear Stimulation System (CSS)

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Change in Electric Current Subjects Indicated They Could Hear a Tone at Certain Frequencies
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).
Measured: Baseline, approximately 2 hours
Speech Intelligibility in Quiet Environment
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).
Measured: Baseline, approximately 2 hours
Speech Intelligibility in Quiet and Noisy Environments
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)
Measured: Baseline; approximately 2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Oct 20236 Feb 2025

First posted9 Nov 2021
Study start6 Oct 2023
Primary completion20 Dec 2024
Study completion6 Feb 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05112809
Sponsor's protocol ID: 21-007158
Status last verified: Dec 2025
First submitted: 28 Oct 2021
Last updated: 30 Dec 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

Kingsbury SE, Cevette MJ, Stepanek J, Pradhan GN. Investigating Speech Intelligibility Capabilities of Electrical Auditory Stimulation. Mil Med. 2026 Mar 1;191(3-4):e592-e600. doi: 10.1093/milmed/usaf430.
PubMed 40899906

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Noninvasive Cochlear Stimulation System
ClinicalTrials.gov ID: NCT05112809
Acronym / sponsor ID: 21-007158
Conditions: Healthy
Keywords: Normal hearing
Study type: Interventional
Recruitment status: Completed
Enrolment: 68 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Study start: 6 Oct 2023 (actual)
Primary completion: 20 Dec 2024 (actual)
Study completion: 6 Feb 2025 (actual)
First posted: 9 Nov 2021 (actual)
Results: Posted 30 Dec 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Normal hearing subjects	Experimental	Device: Cochlear Stimulation System (CSS)Subjects with normal hearing will have a standard hearing test utilizing the cochlear stimulation system.
Bilateral hearing impaired	Experimental	Device: Cochlear Stimulation System (CSS)Subjects with bilateral hearing impairment will have a standard hearing test utilizing the cochlear stimulation system.
Asymmetrical hearing-impaired	Experimental	Device: Cochlear Stimulation System (CSS)Subjects with asymmetrical hearing-impairment will have a standard hearing test utilizing the cochlear stimulation system.

Who may qualify

Ages: 21 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Employee of Mayo Clinic.

Key exclusion criteria (8 listed)

Pregnant.
Cochlear implants.
History of fluctuating sensorineural hearing loss.
Skin diseases of the head.
History of acute paroxysmal tachycardia.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cochlear Stimulation System (CSS)Cochlear stimulation with surround sound and noise cancellation	Device	Asymmetrical hearing-impaired, Bilateral hearing impaired, Normal hearing subjects

Primary outcome

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)

Results and safety

Results posted to the registry on 30 Dec 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Normal Hearing Subjects	55	55
Bilateral Hearing Impaired	5	5
Asymmetrical Hearing-impaired	8	8

Primary outcome: Mean Change in Electric Current Subjects Indicated They Could Hear a Tone at Certain Frequencies

Time frame: Baseline, approximately 2 hours. Mean (Standard Deviation). Unit: mA

Measure	Normal Hearing Subjects n = 55	Bilateral Hearing Impaired n = 5	Asymmetrical Hearing-impaired n = 8
250 Hz	2.16 (1.07)	2.88 (1.44)	2.88 (0.97)
500 Hz	1.86 (1.62)	2.93 (1.42)	2.40 (1.14)
1,000 Hz	1.09 (0.42)	1.75 (0.53)	1.70 (0.42)
2,000 Hz	1.29 (0.43)	1.77 (0.81)	1.71 (0.60)
4,000 Hz	1.56 (0.67)	3.50 (2.35)	1.84 (0.68)
8,000 Hz	1.71 (0.79)	2.25 (1.06)	3.00 (1.76)
10,000 Hz	1.97 (1.06)	3.25 (1.06)	3.96 (2.51)
12,500 Hz	2.29 (1.32)	6.00 (3.46)	3.67 (1.47)

Primary outcome: Speech Intelligibility in Quiet Environment

Time frame: Baseline, approximately 2 hours. Mean (Standard Deviation). Unit: percentage of correct scores on MRT

Measure	Normal Hearing Subjects n = 20	Bilateral Hearing Impaired n = 0	Asymmetrical Hearing-impaired n = 0
Forehead	84.38 (14.9)	–	–
Mastoid	94.06 (5.9)	–	–
Neck	84.06 (11.6)	–	–

Population analysed: MRT was not collected from bilateral hearing impaired and asymmetrical hearing-impaired participants. MRT was only used with normal hearing individuals since the bilateral hearing-impaired and asymmetrical hearing-impaired participants had hearing thresholds over 25 dB HL, and therefore, would likely have struggled significantly to perform well on the test. Then, we would not have known if it was due to a weakness in the electrical signal or the participant's hearing loss causing the poor scores

Primary outcome: Speech Intelligibility in Quiet and Noisy Environments

Time frame: Baseline; approximately 2 hours. Mean (Standard Deviation). Unit: percentage of correct MRT scores

Measure	Normal Hearing Subjects n = 30	Bilateral Hearing Impaired n = 0	Asymmetrical Hearing-impaired n = 0
Mastoid-Quiet Environment	93.86 (8.2)	–	–
Wrist-Quiet Environment	93 (9.7)	–	–
Back-Quiet Environment	93.83 (10.2)	–	–
Mastoid-Noisy Environment	85.37 (11.7)	–	–
Wrist-Noisy Environment	86 (12.7)	–	–
Back-Noisy Environment	82.07 (12.5)	–	–

Adverse events

Time frame: Adverse events were collected from the time of informed consent through study completion, approximately 2 hours.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Normal Hearing Subjects	0 of 55 (0%)	0 of 55 (0%)	0 of 55
Bilateral Hearing Impaired	0 of 5 (0%)	0 of 5 (0%)	0 of 5
Asymmetrical Hearing-impaired	0 of 8 (0%)	0 of 8 (0%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40899906Kingsbury SE, Cevette MJ, Stepanek J, Pradhan GN. Investigating Speech Intelligibility Capabilities of Electrical Auditory Stimulation. Mil Med. 2026 Mar 1;191(3-4):e592-e600. doi: 10.1093/milmed/usaf430.
Mayo Clinic Clinical TrialsLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael J Cevette, PhD principal investigator

Mayo Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Cochlear Stimulation System (CSS) in people with Healthy, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change in Electric Current Subjects Indicated They Could Hear a Tone at Certain Frequencies (time frame: Baseline, approximately 2 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05112809, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.