Evaluation of Cochlear (Promontory) Stimulation During Awake Ear Surgery (TONES Study)
ConditionHearing Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAuricle Health Inc.
About this trial
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?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Individual is ≥ 18 years old at the time of consent.
Individual is scheduled for awake ear surgery that will expose the middle ear (subannular tympanostomy tube placement, tympanoplasty, stapes surgery).
Individual is willing to complete intraoperative assessments of promontory stimulation.
Disqualifiers
Individual has had severe-to-profound hearing loss for more than 30 years.
Individual has congenital hearing loss (for the purpose of this study, onset prior to 2 years of age)
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
Hearing loss or auditory processing disorder of neural or central origin
Trial design
Design model
Single group
Treatments tested in this trial
Electrical extracochlear stimulation
DeviceDelivery of electrical extracochlear stimulation using electrodes on the middle ear surface. Real-time feedback from subjects on tolerability and auditory percepts
Treatment groups
18 Participants
are divided into 1 treatment groupGroup A: Electrical extracochlear stimulationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 frame
Time of study procedureSecondary outcomes
1
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).
Time frame
Time of study procedure2
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 frame
Time of study procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Auricle Health Inc.
Lead sponsor
The Cleveland Clinic
Collaborator
Source ClinicalTrials.gov