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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07402941 on ClinicalTrials.gov