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NCT Number: NCT07402941

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?

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Key information

Conditions

Hearing Disorder Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location status: Recruiting

Location contact

John Research Coordinator

CONTACT

[email protected]

2164442200

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electrical extracochlear stimulation

Device

Delivery of electrical extracochlear stimulation using electrodes on the middle ear surface. Real-time feedback from subjects on tolerability and auditory percepts

Primary outcomes

  1. Stimulation discrimination

    Time frame: Time of study procedure

    Accuracy of comparison of paired stimulation presentations as indicated by subject. This will be measured using a same-different task, where two stimulation paradigms are compared. The participant will be presented two consecutive stimuli, randomized to be the same or different. The participant will verbalize whether they felt the stimuli were the same or different. This will be repeated five times and graded on a percentage scale.

Secondary outcomes

  1. Threshold and most comfortable level

    Time frame: Time of study procedure

    Stimuli will be presented at different positions on the cochlear promontory. For each position the current applied will be gradually increased in small increments from zero. The current threshold at which the stimulus is first detected by the participant will be recorded. The current level will then be increased to a level at which the participant reliably and comfortably detects the stimulus which will be recorded as the Most Comfortable Level (MCL).

  2. Stimulation effects

    Time frame: Time of study procedure

    The subject will ask the participant to report any new sensations or discomfort experienced during the stimulation. The investigator will also be monitoring the patient for signs of discomfort or off-target nerve stimulation such as facial twitching. These effects will be recorded with the stimulation parameters and location used.

Study contacts

Contact information is provided by the study sponsor or research team.

Francis Wong

CONTACT

[email protected]

John O'Neill

CONTACT

[email protected]

2164458175

Sponsors and collaborators

Lead sponsor

Auricle Health Inc.

Industry

Collaborators

  • The Cleveland Clinic

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 11, 2026
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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