Trial Outcomes & Findings for Noninvasive Cochlear Stimulation System (NCT NCT05112809)
NCT ID: NCT05112809
Last Updated: 2025-12-30
Results Overview
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).
COMPLETED
NA
68 participants
Baseline, approximately 2 hours
2025-12-30
Participant Flow
Participant milestones
| Measure |
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
|
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
|
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
55
|
5
|
8
|
|
Overall Study
COMPLETED
|
55
|
5
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Noninvasive Cochlear Stimulation System
Baseline characteristics by cohort
| Measure |
Normal Hearing Subjects
n=55 Participants
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
|
Bilateral Hearing Impaired
n=5 Participants
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
|
Asymmetrical Hearing-impaired
n=8 Participants
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
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
33.78 years
STANDARD_DEVIATION 9.33 • n=174 Participants
|
56.8 years
STANDARD_DEVIATION 11.39 • n=166 Participants
|
59 years
STANDARD_DEVIATION 13.44 • n=167 Participants
|
38.51 years
STANDARD_DEVIATION 13.84 • n=164 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=174 Participants
|
3 Participants
n=166 Participants
|
3 Participants
n=167 Participants
|
37 Participants
n=164 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=174 Participants
|
2 Participants
n=166 Participants
|
5 Participants
n=167 Participants
|
31 Participants
n=164 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=174 Participants
|
2 Participants
n=166 Participants
|
2 Participants
n=167 Participants
|
15 Participants
n=164 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=174 Participants
|
2 Participants
n=166 Participants
|
5 Participants
n=167 Participants
|
44 Participants
n=164 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=174 Participants
|
1 Participants
n=166 Participants
|
1 Participants
n=167 Participants
|
9 Participants
n=164 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
0 Participants
n=164 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
6 Participants
n=164 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
0 Participants
n=164 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=174 Participants
|
1 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
4 Participants
n=164 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=174 Participants
|
3 Participants
n=166 Participants
|
8 Participants
n=167 Participants
|
49 Participants
n=164 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
0 Participants
n=164 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=174 Participants
|
1 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
9 Participants
n=164 Participants
|
|
Region of Enrollment
United States
|
55 participants
n=174 Participants
|
5 participants
n=166 Participants
|
8 participants
n=167 Participants
|
68 participants
n=164 Participants
|
PRIMARY outcome
Timeframe: Baseline, approximately 2 hoursEvaluated 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).
Outcome measures
| Measure |
Normal Hearing Subjects
n=55 Participants
Subjects with normal hearing had a standard hearing test utilizing the cochlear stimulation system.
Cochlear Stimulation System (CSS): Cochlear stimulation with surround sound and noise cancellation
|
Bilateral Hearing Impaired
n=5 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
|
Asymmetrical Hearing-impaired
n=8 Participants
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
|
|---|---|---|---|
|
Mean Change in Electric Current Subjects Indicated They Could Hear a Tone at Certain Frequencies
250 Hz
|
2.16 mA
Standard Deviation 1.07
|
2.88 mA
Standard Deviation 1.44
|
2.88 mA
Standard Deviation 0.97
|
|
Mean Change in Electric Current Subjects Indicated They Could Hear a Tone at Certain Frequencies
500 Hz
|
1.86 mA
Standard Deviation 1.62
|
2.93 mA
Standard Deviation 1.42
|
2.40 mA
Standard Deviation 1.14
|
|
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
|
1.75 mA
Standard Deviation 0.53
|
1.70 mA
Standard Deviation 0.42
|
|
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
|
1.77 mA
Standard Deviation 0.81
|
1.71 mA
Standard Deviation 0.60
|
|
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
|
3.50 mA
Standard Deviation 2.35
|
1.84 mA
Standard Deviation 0.68
|
|
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
|
2.25 mA
Standard Deviation 1.06
|
3.00 mA
Standard Deviation 1.76
|
|
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
|
3.25 mA
Standard Deviation 1.06
|
3.96 mA
Standard Deviation 2.51
|
|
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
|
6.00 mA
Standard Deviation 3.46
|
3.67 mA
Standard Deviation 1.47
|
|
Mean Change in Electric Current Subjects Indicated They Could Hear a Tone at Certain Frequencies
16,000 Hz
|
2.94 mA
Standard Deviation 1.30
|
5.00 mA
Standard Deviation 0.00
|
4.21 mA
Standard Deviation 1.25
|
PRIMARY outcome
Timeframe: Baseline, approximately 2 hoursPopulation: 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
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).
Outcome measures
| Measure |
Normal Hearing Subjects
n=20 Participants
Subjects with normal hearing had a standard hearing test utilizing the cochlear stimulation system.
Cochlear Stimulation System (CSS): Cochlear stimulation with surround sound and noise cancellation
|
Bilateral Hearing Impaired
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
|
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
|
|---|---|---|---|
|
Speech Intelligibility in Quiet Environment
Forehead
|
84.38 percentage of correct scores on MRT
Standard Deviation 14.9
|
—
|
—
|
|
Speech Intelligibility in Quiet Environment
Mastoid
|
94.06 percentage of correct scores on MRT
Standard Deviation 5.9
|
—
|
—
|
|
Speech Intelligibility in Quiet Environment
Neck
|
84.06 percentage of correct scores on MRT
Standard Deviation 11.6
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline; approximately 2 hoursPopulation: 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
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)
Outcome measures
| Measure |
Normal Hearing Subjects
n=30 Participants
Subjects with normal hearing had a standard hearing test utilizing the cochlear stimulation system.
Cochlear Stimulation System (CSS): Cochlear stimulation with surround sound and noise cancellation
|
Bilateral Hearing Impaired
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
|
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
|
|---|---|---|---|
|
Speech Intelligibility in Quiet and Noisy Environments
Mastoid-Quiet Environment
|
93.86 percentage of correct MRT scores
Standard Deviation 8.2
|
—
|
—
|
|
Speech Intelligibility in Quiet and Noisy Environments
Wrist-Quiet Environment
|
93 percentage of correct MRT scores
Standard Deviation 9.7
|
—
|
—
|
|
Speech Intelligibility in Quiet and Noisy Environments
Back-Quiet Environment
|
93.83 percentage of correct MRT scores
Standard Deviation 10.2
|
—
|
—
|
|
Speech Intelligibility in Quiet and Noisy Environments
Mastoid-Noisy Environment
|
85.37 percentage of correct MRT scores
Standard Deviation 11.7
|
—
|
—
|
|
Speech Intelligibility in Quiet and Noisy Environments
Wrist-Noisy Environment
|
86 percentage of correct MRT scores
Standard Deviation 12.7
|
—
|
—
|
|
Speech Intelligibility in Quiet and Noisy Environments
Back-Noisy Environment
|
82.07 percentage of correct MRT scores
Standard Deviation 12.5
|
—
|
—
|
Adverse Events
Normal Hearing Subjects
Bilateral Hearing Impaired
Asymmetrical Hearing-impaired
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place