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

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?

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.

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