Hearing Disorder
Conditions
Keywords
Hearing, Cochlea
Brief summary
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?
Detailed description
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.
Interventions
DEVICEElectrical extracochlear stimulation
Delivery of electrical extracochlear stimulation using electrodes on the middle ear surface. Real-time feedback from subjects on tolerability and auditory percepts
Sponsors
Auricle Health Inc.
The Cleveland Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Individual is ≥ 18 years old at the time of consent. 2. Individual is scheduled for awake ear surgery that will expose the middle ear (subannular tympanostomy tube placement, tympanoplasty, stapes surgery). 3. Individual is willing to complete intraoperative assessments of promontory stimulation.
Exclusion criteria
1. Individual has had severe-to-profound hearing loss for more than 30 years. 2. Individual has congenital hearing loss (for the purpose of this study, onset prior to 2 years of age) 3. Ear canal will not accommodate a speculum with minimum outer diameter (OD) of 4.0 mm or other anatomic challenges present as determined by the study investigator 4. Hearing loss or auditory processing disorder of neural or central origin 5. Active middle ear infection 6. History of cholesteatoma treated within the past 2 years 7. Ossification of the cochlear or other previously identified cochlear anomaly 8. Prior major head trauma (stroke, hemorrhage, traumatic brain injury) within past 2 years 9. Contralateral presence of cochlear implant 10. Individual is pregnant. 11. Individual is unable or unwilling to complete training for qualitative evaluation of promontory electrical stimulation. 12. A disability that could interfere with intraoperative evaluations as determined by study investigator. 13. Profound tinnitus 14. History of vertigo that would interfere with the planned investigation as determined by the principal investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stimulation discrimination | Time of study procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Threshold and most comfortable level | Time of study procedure | 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). |
| Stimulation effects | Time of study procedure | 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. |
Countries
United States
Contacts
CONTACTJohn O'Neill
CONTACTFrancis Wong
Outcome results
None listed