Evaluation of Cochlear (Promontory) Stimulation During Awake Ear Surgery (TONES Study)
NCT07402941 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2026-02-11
Summary
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
- Hearing Disorder
Interventions
- DEVICE
-
Electrical extracochlear stimulation
Delivery of electrical extracochlear stimulation using electrodes on the middle ear surface. Real-time feedback from subjects on tolerability and auditory percepts
Sponsors & Collaborators
-
The Cleveland Clinic
collaborator OTHER -
Auricle Health Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-06-02
- Primary Completion
- 2026-05-31
- Completion
- 2026-07-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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