NCT07402941 Evaluation of Cochlear (Promontory) Stimulation During Awake Ear Surgery (TONES Study)
| NCT ID | NCT07402941 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Auricle Health Inc. |
| Condition | Hearing Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2025-06-02 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 18 participants in total. It began in 2025-06-02 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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?
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07402941 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hearing Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07402941 currently recruiting?
Yes, NCT07402941 is actively recruiting participants. Contact the research team at oneillj2@ccf.org for enrollment information.
Where is the NCT07402941 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT07402941 clinical trial?
NCT07402941 is sponsored by Auricle Health Inc.. The trial plans to enroll 18 participants.