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Recruiting NCT07402941

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

No phase Interventional Hearing Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Electrical extracochlear stimulation.
Who it may be relevant to
Registry conditions: Hearing Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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?

Detailed description

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.

Interventions

  • Device 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 measures

  • Stimulation discrimination [Time frame: Time of study procedure]
Secondary outcome measures (2)
  • Threshold and most comfortable level [Time frame: Time of study procedure]
  • Stimulation effects [Time frame: Time of study procedure]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • Cleveland Clinic — Cleveland

Identifiers

NCT: NCT07402941 · CLN-0001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗