🔎 Trials Near Me

Home › Hearing Problems in Children › NCT07402941

Evaluation of Cochlear (Promontory) Stimulation During Awake Ear Surgery (TONES Study)

Recruiting

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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

About the study

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?

What is being tested

Sponsor: Auricle Health Inc. · Participants: 18 · Started: Jun 2, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07402941

Locations in the U.S.

OhioCleveland Clinic, Cleveland

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.