Actively Recruiting
Evaluation of Cochlear (Promontory) Stimulation During Awake Ear Surgery (TONES Study)
Led by Auricle Health Inc. · Updated on 2026-02-11
18
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
Sponsors
A
Auricle Health Inc.
Lead Sponsor
T
The Cleveland Clinic
Collaborating Sponsor
AI-Summary
What this Trial 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?
CONDITIONS
Official Title
Evaluation of Cochlear (Promontory) Stimulation During Awake Ear Surgery (TONES Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individual is 18 years old or older at the time of consent
- Individual is scheduled for awake ear surgery exposing the middle ear (such as tympanostomy tube placement, tympanoplasty, or stapes surgery)
- Individual is willing to complete intraoperative assessments of promontory stimulation
You will not qualify if you...
- Severe-to-profound hearing loss lasting more than 30 years
- Congenital hearing loss with onset before 2 years of age
- Ear canal cannot accommodate a speculum with minimum outer diameter of 4.0 mm or has other anatomical challenges
- 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 cochlea or other known cochlear anomalies
- Major head trauma (stroke, hemorrhage, traumatic brain injury) within past 2 years
- Presence of cochlear implant in the opposite ear
- Pregnancy
- Unable or unwilling to complete training for qualitative evaluation of promontory electrical stimulation
- Disability interfering with intraoperative evaluations as determined by the study investigator
- Profound tinnitus
- History of vertigo interfering with the planned investigation as determined by the principal investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
J
John O'Neill
CONTACT
F
Francis Wong
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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