Trying brief cochlear (promontory) electrical stimulation during awake ear surgery.

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

This study tries short electrical pulses on the cochlea during awake middle-ear surgery to see if adult patients can hear different pitches.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Auricle Health Inc. (Industry-sponsored)
• Locations: 1 site (Cleveland, Ohio)
• Trial ID: NCT07402941 on ClinicalTrials.gov

What this trial studies

This is a feasibility study of minimally invasive extracochlear (promontory) stimulation performed during awake middle-ear surgery. During a brief intraoperative procedure, investigators will apply short electrical pulses at different positions and stimulation settings while participants report any sounds they perceive in real time. The study aims to establish comfortable and tolerable auditory thresholds and to map how stimulation position and parameters relate to the perceived frequency of sensations. Data will be used to determine whether this approach could inform future hearing-restoration devices or procedures.

Who should consider this trial

Good fit: Ideal candidates are adults (≥18 years) scheduled for awake middle-ear surgery who can tolerate intraoperative testing and are willing to provide real-time feedback on perceived sounds.

Not a fit: Patients with long-standing severe-to-profound or congenital hearing loss, cochlear ossification, central auditory disorders, or active middle-ear infection are unlikely to benefit from the procedure.

Why it matters

Potential benefit: If successful, this approach could point to a less invasive way to restore or supplement hearing by using brief electrical stimulation of the cochlea.

How similar studies have performed: Promontory stimulation has been used diagnostically in the past, but using extracochlear stimulation as a minimally invasive hearing-restoration approach remains largely novel and early-stage.

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

Where this trial is running

Cleveland, Ohio

• Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)

Study contacts

• Study coordinator: John O'Neill

Conditions Hearing Disorder; Hearing; Cochlea