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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal hearing subjects | Experimental | Subjects with normal hearing will have a standard hearing test utilizing the cochlear stimulation system. |
|
| Bilateral hearing impaired | Experimental | Subjects with bilateral hearing impairment will have a standard hearing test utilizing the cochlear stimulation system. |
|
| Asymmetrical hearing-impaired | Experimental | Subjects with asymmetrical hearing-impairment will have a standard hearing test utilizing the cochlear stimulation system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cochlear Stimulation System (CSS) | Device | Cochlear stimulation with surround sound and noise cancellation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 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) |
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Inclusion Criteria:
- Employee of Mayo Clinic.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael J Cevette, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40899906 | Derived | 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. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Normal Hearing Subjects | Subjects with normal hearing will have a standard hearing test utilizing the cochlear stimulation system. Cochlear Stimulation System (CSS): Cochlear stimulation with surround sound and noise cancellation |
| FG001 | Bilateral Hearing Impaired | Subjects with bilateral hearing impairment will have a standard hearing test utilizing the cochlear stimulation system. Cochlear Stimulation System (CSS): Cochlear stimulation with surround sound and noise cancellation |
| FG002 | Asymmetrical Hearing-impaired | Subjects with asymmetrical hearing-impairment will have a standard hearing test utilizing the cochlear stimulation system. Cochlear Stimulation System (CSS): Cochlear stimulation with surround sound and noise cancellation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Normal Hearing Subjects | Subjects with normal hearing will have a standard hearing test utilizing the cochlear stimulation system. Cochlear Stimulation System (CSS): Cochlear stimulation with surround sound and noise cancellation |
| BG001 | Bilateral Hearing Impaired |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | Standard Deviation | mA | Baseline, approximately 2 hours |
|
Adverse events were collected from the time of informed consent through study completion, approximately 2 hours.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Normal Hearing Subjects | Subjects with normal hearing will have a standard hearing test utilizing the cochlear stimulation system. Cochlear Stimulation System (CSS): Cochlear stimulation with surround sound and noise cancellation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Cevette, Ph.D. | Mayo Clinic | 480-301-4380 | mcevette@mayo.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 12, 2024 | Nov 13, 2025 | Prot_000.pdf |
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| Baseline; approximately 2 hours |
Subjects with bilateral hearing impairment will have a standard hearing test utilizing the cochlear stimulation system. Cochlear Stimulation System (CSS): Cochlear stimulation with surround sound and noise cancellation |
| BG002 | Asymmetrical Hearing-impaired | Subjects with asymmetrical hearing-impairment will have a standard hearing test utilizing the cochlear stimulation system. Cochlear Stimulation System (CSS): Cochlear stimulation with surround sound and noise cancellation |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Subjects with bilateral hearing impairment had a standard hearing test utilizing the cochlear stimulation system.
Cochlear Stimulation System (CSS): Cochlear stimulation with surround sound and noise cancellation
| OG002 | Asymmetrical Hearing-impaired | Subjects with asymmetrical hearing-impairment had a standard hearing test utilizing the cochlear stimulation system. Cochlear Stimulation System (CSS): Cochlear stimulation with surround sound and noise cancellation |
|
|
| Primary | 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). | 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 | Posted | Mean | Standard Deviation | percentage of correct scores on MRT | Baseline, approximately 2 hours |
|
|
|
| Primary | 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) | 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 | Posted | Mean | Standard Deviation | percentage of correct MRT scores | Baseline; approximately 2 hours |
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| 55 |
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| 55 |
| EG001 | Bilateral Hearing Impaired | Subjects with bilateral hearing impairment will have a standard hearing test utilizing the cochlear stimulation system. Cochlear Stimulation System (CSS): Cochlear stimulation with surround sound and noise cancellation | 0 | 5 | 0 | 5 | 0 | 5 |
| EG002 | Asymmetrical Hearing-impaired | Subjects with asymmetrical hearing-impairment will have a standard hearing test utilizing the cochlear stimulation system. Cochlear Stimulation System (CSS): Cochlear stimulation with surround sound and noise cancellation | 0 | 8 | 0 | 8 | 0 | 8 |
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Mastoid-Noisy Environment |
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| Wrist-Noisy Environment |
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| Back-Noisy Environment |
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