NCT07402941 · Auricle Health Inc.
Evaluation of Cochlear (Promontory) Stimulation During Awake Ear Surgery (TONES Study)
What this 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Cleveland, Ohio
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 11, 2026 · Source of record for eligibility and locations