Recruiting

Observational Study

Sponsor:

Auricle Health Inc.

Code:

NCT07402941

Conditions

Hearing Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Electrical extracochlear stimulation

Study Details

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

Study ID

NCT07402941

Start date

Jun 2, 2025

Status verified date

Feb, 2026

Completion date

Jul, 2026

Anticipated

Primary completion date

May, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

18 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Electrical extracochlear stimulation

Electrical extracochlear stimulation and psychoacoustic testing

Interventions

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

Primary outcome measure

  • Stimulation discrimination [ Time Frame: Time of study procedure ]

Central Contacts and Locations

Central contacts

Locations

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

John Research Coordinator

2164442200ONEILLJ2@ccf.org

More Information

Sponsor

Auricle Health Inc.

Last update posted

Feb 11, 2026

Last verified

Feb, 2026

Keywords

  • Hearing
  • Cochlea

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Auricle Health Inc. on 2026-02-11.