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
Qualifiers
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
Treatments tested in this trial
- Electrical extracochlear stimulation
Treatment groups
18 Participants
are divided into 1 treatment groupSponsors and collaborators
Auricle Health Inc.
Lead sponsor
The Cleveland Clinic
Collaborator
Source ClinicalTrials.gov