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| Name | Class |
|---|---|
| The Cleveland Clinic | OTHER |
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The goal of this clinical trial is to learn if short electrical signals can be heard in adult subjects who are otherwise having surgery on their ear.
The main question it aims to answer is:
Can an individual accurately hear different frequencies resulting from the short electrical signals?
The goal of this interventional clinical study is to investigate the feasibility for minimally invasive electrical stimulation of the cochlea as a mechanism for hearing restoration. The main aims of the study are to:
Establish comfortable and tolerable auditory thresholds Investigate the relationship between the position of stimulation, the stimulation parameters and the perceived frequency of any auditory sensation.
This study will enroll patients undergoing middle ear surgery where a brief study procedure will be performed during the course or their surgery. Participants will provide real-time feedback on any auditory sensations and percepts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electrical extracochlear stimulation | Experimental | Electrical extracochlear stimulation and psychoacoustic testing |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrical extracochlear stimulation | Device | Delivery of electrical extracochlear stimulation using electrodes on the middle ear surface. Real-time feedback from subjects on tolerability and auditory percepts |
| Measure | Description | Time Frame |
|---|---|---|
| Stimulation discrimination | Accuracy of comparison of paired stimulation presentations as indicated by subject. This will be measured using a same-different task, where two stimulation paradigms are compared. The participant will be presented two consecutive stimuli, randomized to be the same or different. The participant will verbalize whether they felt the stimuli were the same or different. This will be repeated five times and graded on a percentage scale. | Time of study procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Threshold and most comfortable level | Stimuli will be presented at different positions on the cochlear promontory. For each position the current applied will be gradually increased in small increments from zero. The current threshold at which the stimulus is first detected by the participant will be recorded. The current level will then be increased to a level at which the participant reliably and comfortably detects the stimulus which will be recorded as the Most Comfortable Level (MCL). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| John O'Neill | Contact | 2164458175 | oneillj2@ccf.org | |
| Francis Wong | Contact | clinicalaffairs@auricle.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Recruiting | Cleveland | Ohio | 44195 | United States |
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| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| ID | Term |
|---|---|
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
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| Time of study procedure |
| Stimulation effects | The subject will ask the participant to report any new sensations or discomfort experienced during the stimulation. The investigator will also be monitoring the patient for signs of discomfort or off-target nerve stimulation such as facial twitching. These effects will be recorded with the stimulation parameters and location used. | Time of study procedure |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |