Evaluation of Cochlear (Promontory) Stimulation During Awake Ear Surgery (TONES Study)
Auricle Health Inc. · with The Cleveland Clinic · NCT07402941
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Not applicable
- Target enrollment
- 18
- US sites recruiting
- 1
- Study start
- June 2, 2025
- Record last updated
- February 11, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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?
Being studied: Electrical extracochlear stimulation
Conditions: Hearing Disorder
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
- Active middle ear infection
- History of cholesteatoma treated within the past 2 years
- Ossification of the cochlear or other previously identified cochlear anomaly
- Prior major head trauma (stroke, hemorrhage, traumatic brain injury) within past 2 years
- Contralateral presence of cochlear implant
- Individual is pregnant.
- Individual is unable or unwilling to complete training for qualitative evaluation of promontory electrical stimulation.
- A disability that could interfere with intraoperative evaluations as determined by study investigator.
- Profound tinnitus
- History of vertigo that would interfere with the planned investigation as determined by the principal investigator
Recruiting US locations
Cleveland Clinic
Cleveland, OH 44195
Site contact: John Research Coordinator · 2164442200 · ONEILLJ2@ccf.org
Study contacts (from the official record)
- John O'Neill · 2164458175 · oneillj2@ccf.org
- Francis Wong · clinicalaffairs@auricle.com