Healthy
Conditions
Keywords
Normal hearing
Brief 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.
Interventions
DEVICECochlear Stimulation System (CSS)
Cochlear stimulation with surround sound and noise cancellation
Sponsors
Mayo Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Electric Current Subjects Indicated They Could Hear a Tone at Certain Frequencies | 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 | 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 | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 55 |
| 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 | 5 |
| 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 | 8 |
| Total | 68 |
Baseline characteristics
| Characteristic | Total | Normal Hearing Subjects | Bilateral Hearing Impaired | Asymmetrical Hearing-impaired |
|---|---|---|---|---|
| Age, Continuous | 38.51 years STANDARD_DEVIATION 13.84 | 33.78 years STANDARD_DEVIATION 9.33 | 56.8 years STANDARD_DEVIATION 11.39 | 59 years STANDARD_DEVIATION 13.44 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants | 11 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 44 Participants | 37 Participants | 2 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 9 Participants | 7 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 6 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 3 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants | 8 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 49 Participants | 38 Participants | 3 Participants | 8 Participants |
| Region of Enrollment United States | 68 participants | 55 participants | 5 participants | 8 participants |
| Sex: Female, Male Female | 37 Participants | 31 Participants | 3 Participants | 3 Participants |
| Sex: Female, Male Male | 31 Participants | 24 Participants | 2 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 55 | 0 / 5 | 0 / 8 |
| other Total, other adverse events | 0 / 55 | 0 / 5 | 0 / 8 |
| serious Total, serious adverse events | 0 / 55 | 0 / 5 | 0 / 8 |
Outcome results
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).
Time frame: Baseline, approximately 2 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Normal Hearing Subjects | Mean Change in Electric Current Subjects Indicated They Could Hear a Tone at Certain Frequencies | 8,000 Hz | 1.71 mA | Standard Deviation 0.79 |
| Normal Hearing Subjects | Mean Change in Electric Current Subjects Indicated They Could Hear a Tone at Certain Frequencies | 250 Hz | 2.16 mA | Standard Deviation 1.07 |
| Normal Hearing Subjects | Mean Change in Electric Current Subjects Indicated They Could Hear a Tone at Certain Frequencies | 500 Hz | 1.86 mA | Standard Deviation 1.62 |
| Normal Hearing Subjects | Mean Change in Electric Current Subjects Indicated They Could Hear a Tone at Certain Frequencies | 1,000 Hz | 1.09 mA | Standard Deviation 0.42 |
| Normal Hearing Subjects | Mean Change in Electric Current Subjects Indicated They Could Hear a Tone at Certain Frequencies | 2,000 Hz | 1.29 mA | Standard Deviation 0.43 |
| Normal Hearing Subjects | Mean Change in Electric Current Subjects Indicated They Could Hear a Tone at Certain Frequencies | 4,000 Hz | 1.56 mA | Standard Deviation 0.67 |
| Normal Hearing Subjects | Mean Change in Electric Current Subjects Indicated They Could Hear a Tone at Certain Frequencies | 10,000 Hz | 1.97 mA | Standard Deviation 1.06 |
| Normal Hearing Subjects | Mean Change in Electric Current Subjects Indicated They Could Hear a Tone at Certain Frequencies | 12,500 Hz | 2.29 mA | Standard Deviation 1.32 |
| Normal Hearing Subjects | Mean Change in Electric Current Subjects Indicated They Could Hear a Tone at Certain Frequencies | 16,000 Hz | 2.94 mA | Standard Deviation 1.3 |
| Bilateral Hearing Impaired | Mean Change in Electric Current Subjects Indicated They Could Hear a Tone at Certain Frequencies | 4,000 Hz | 3.50 mA | Standard Deviation 2.35 |
| Bilateral Hearing Impaired | Mean Change in Electric Current Subjects Indicated They Could Hear a Tone at Certain Frequencies | 10,000 Hz | 3.25 mA | Standard Deviation 1.06 |
| Bilateral Hearing Impaired | Mean Change in Electric Current Subjects Indicated They Could Hear a Tone at Certain Frequencies | 250 Hz | 2.88 mA | Standard Deviation 1.44 |
| Bilateral Hearing Impaired | Mean Change in Electric Current Subjects Indicated They Could Hear a Tone at Certain Frequencies | 12,500 Hz | 6.00 mA | Standard Deviation 3.46 |
| Bilateral Hearing Impaired | Mean Change in Electric Current Subjects Indicated They Could Hear a Tone at Certain Frequencies | 8,000 Hz | 2.25 mA | Standard Deviation 1.06 |
| Bilateral Hearing Impaired | Mean Change in Electric Current Subjects Indicated They Could Hear a Tone at Certain Frequencies | 500 Hz | 2.93 mA | Standard Deviation 1.42 |
| Bilateral Hearing Impaired | Mean Change in Electric Current Subjects Indicated They Could Hear a Tone at Certain Frequencies | 2,000 Hz | 1.77 mA | Standard Deviation 0.81 |
| Bilateral Hearing Impaired | Mean Change in Electric Current Subjects Indicated They Could Hear a Tone at Certain Frequencies | 16,000 Hz | 5.00 mA | Standard Deviation 0 |
| Bilateral Hearing Impaired | Mean Change in Electric Current Subjects Indicated They Could Hear a Tone at Certain Frequencies | 1,000 Hz | 1.75 mA | Standard Deviation 0.53 |
| Asymmetrical Hearing-impaired | Mean Change in Electric Current Subjects Indicated They Could Hear a Tone at Certain Frequencies | 16,000 Hz | 4.21 mA | Standard Deviation 1.25 |
| Asymmetrical Hearing-impaired | Mean Change in Electric Current Subjects Indicated They Could Hear a Tone at Certain Frequencies | 2,000 Hz | 1.71 mA | Standard Deviation 0.6 |
| Asymmetrical Hearing-impaired | Mean Change in Electric Current Subjects Indicated They Could Hear a Tone at Certain Frequencies | 12,500 Hz | 3.67 mA | Standard Deviation 1.47 |
| Asymmetrical Hearing-impaired | Mean Change in Electric Current Subjects Indicated They Could Hear a Tone at Certain Frequencies | 4,000 Hz | 1.84 mA | Standard Deviation 0.68 |
| Asymmetrical Hearing-impaired | Mean Change in Electric Current Subjects Indicated They Could Hear a Tone at Certain Frequencies | 8,000 Hz | 3.00 mA | Standard Deviation 1.76 |
| Asymmetrical Hearing-impaired | Mean Change in Electric Current Subjects Indicated They Could Hear a Tone at Certain Frequencies | 1,000 Hz | 1.70 mA | Standard Deviation 0.42 |
| Asymmetrical Hearing-impaired | Mean Change in Electric Current Subjects Indicated They Could Hear a Tone at Certain Frequencies | 250 Hz | 2.88 mA | Standard Deviation 0.97 |
| Asymmetrical Hearing-impaired | Mean Change in Electric Current Subjects Indicated They Could Hear a Tone at Certain Frequencies | 10,000 Hz | 3.96 mA | Standard Deviation 2.51 |
| Asymmetrical Hearing-impaired | Mean Change in Electric Current Subjects Indicated They Could Hear a Tone at Certain Frequencies | 500 Hz | 2.40 mA | Standard Deviation 1.14 |
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)
Time frame: Baseline; approximately 2 hours
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Normal Hearing Subjects | Speech Intelligibility in Quiet and Noisy Environments | Mastoid-Quiet Environment | 93.86 percentage of correct MRT scores | Standard Deviation 8.2 |
| Normal Hearing Subjects | Speech Intelligibility in Quiet and Noisy Environments | Wrist-Quiet Environment | 93 percentage of correct MRT scores | Standard Deviation 9.7 |
| Normal Hearing Subjects | Speech Intelligibility in Quiet and Noisy Environments | Back-Quiet Environment | 93.83 percentage of correct MRT scores | Standard Deviation 10.2 |
| Normal Hearing Subjects | Speech Intelligibility in Quiet and Noisy Environments | Mastoid-Noisy Environment | 85.37 percentage of correct MRT scores | Standard Deviation 11.7 |
| Normal Hearing Subjects | Speech Intelligibility in Quiet and Noisy Environments | Wrist-Noisy Environment | 86 percentage of correct MRT scores | Standard Deviation 12.7 |
| Normal Hearing Subjects | Speech Intelligibility in Quiet and Noisy Environments | Back-Noisy Environment | 82.07 percentage of correct MRT scores | Standard Deviation 12.5 |
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).
Time frame: Baseline, approximately 2 hours
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Normal Hearing Subjects | Speech Intelligibility in Quiet Environment | Forehead | 84.38 percentage of correct scores on MRT | Standard Deviation 14.9 |
| Normal Hearing Subjects | Speech Intelligibility in Quiet Environment | Mastoid | 94.06 percentage of correct scores on MRT | Standard Deviation 5.9 |
| Normal Hearing Subjects | Speech Intelligibility in Quiet Environment | Neck | 84.06 percentage of correct scores on MRT | Standard Deviation 11.6 |