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

Study Overview

• Status: Recruiting
• Conditions: Hearing Disorder
• Intervention / Treatment: Device: Electrical extracochlear stimulation

Detailed Description

The goal of this interventional clinical study is to investigate the feasibility for minimally invasive electrical stimulation of the cochlea as a mechanism for hearing restoration. The main aims of the study are to:

Establish comfortable and tolerable auditory thresholds Investigate the relationship between the position of stimulation, the stimulation parameters and the perceived frequency of any auditory sensation.

This study will enroll patients undergoing middle ear surgery where a brief study procedure will be performed during the course or their surgery. Participants will provide real-time feedback on any auditory sensations and percepts.

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: John O'Neill; Phone Number: 2164458175; Email: oneillj2@ccf.org
• Study Contact Backup: Name: Francis Wong; Email: clinicalaffairs@auricle.com

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic
      • Contact: John Research Coordinator; Phone Number: 2164442200; Email: ONEILLJ2@ccf.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electrical extracochlear stimulation; Electrical extracochlear stimulation and psychoacoustic testing	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stimulation discrimination	Accuracy of comparison of paired stimulation presentations as indicated by subject. This will be measured using a same-different task, where two stimulation paradigms are compared. The participant will be presented two consecutive stimuli, randomized to be the same or different. The participant will verbalize whether they felt the stimuli were the same or different. This will be repeated five times and graded on a percentage scale.	Time of study procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Threshold and most comfortable level	Stimuli will be presented at different positions on the cochlear promontory. For each position the current applied will be gradually increased in small increments from zero. The current threshold at which the stimulus is first detected by the participant will be recorded. The current level will then be increased to a level at which the participant reliably and comfortably detects the stimulus which will be recorded as the Most Comfortable Level (MCL).	Time of study procedure
Stimulation effects	The subject will ask the participant to report any new sensations or discomfort experienced during the stimulation. The investigator will also be monitoring the patient for signs of discomfort or off-target nerve stimulation such as facial twitching. These effects will be recorded with the stimulation parameters and location used.	Time of study procedure

Collaborators and Investigators

• Sponsor: Auricle Health Inc.
• Collaborators: The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: August 12, 2025
• First Submitted That Met QC Criteria: February 4, 2026
• First Posted (Actual): February 11, 2026

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Hearing; Cochlea
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hearing Disorders
• Other Study ID Numbers: CLN-0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes