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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Auricle Health Inc.
Study ID
NCT07402941
Status
Recruiting

Conditions

  • Hearing Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Electrical extracochlear stimulation — DEVICE
    Delivery of electrical extracochlear stimulation using electrodes on the middle ear surface. Real-time feedback from subjects on tolerability and auditory percepts

Study Details

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?

Key Dates

Start date
Jun 2, 2025
Status verified
Feb 2026
Primary completion
May 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Electrical extracochlear stimulation
    Electrical extracochlear stimulation and psychoacoustic testing

Primary Outcome Measure

Stimulation discrimination [ Time Frame: Time of study procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland ClinicClevelandOhio44195
John Research Coordinator
2164442200

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