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

NCT07402941 | Recruiting FDA Device

• 1 other identifier: CLN-0001
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Hearing; Cochlea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Threshold and most comfortable level

  Time of study procedure

• Stimulation effects

  Time of study procedure

Study Arms (1)

Electrical extracochlear stimulation

EXPERIMENTAL

Electrical extracochlear stimulation and psychoacoustic testing

Device: Electrical extracochlear stimulation

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

Electrical extracochlear stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individual is ≥ 18 years old at the time of consent.
• Individual is scheduled for awake ear surgery that will expose the middle ear (subannular tympanostomy tube placement, tympanoplasty, stapes surgery).
• Individual is willing to complete intraoperative assessments of promontory stimulation.

You may not qualify if:

• Individual has had severe-to-profound hearing loss for more than 30 years.
• Individual has congenital hearing loss (for the purpose of this study, onset prior to 2 years of age)
• 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
• 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 cochlear or other previously identified cochlear anomaly
• Prior major head trauma (stroke, hemorrhage, traumatic brain injury) within past 2 years
• Contralateral presence of cochlear implant
• Individual is pregnant.
• Individual is unable or unwilling to complete training for qualitative evaluation of promontory electrical stimulation.
• A disability that could interfere with intraoperative evaluations as determined by study investigator.
• Profound tinnitus
• History of vertigo that would interfere with the planned investigation as determined by the principal investigator

Sponsors & Collaborators

• Auricle Health Inc.: lead
• The Cleveland Clinic: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Hearing Disorders

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

John O'Neill

CONTACT

2164458175; oneillj2@ccf.org

Francis Wong

CONTACT

clinicalaffairs@auricle.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: February 11, 2026
• Study Start: June 2, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)