NCT07402941

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Auricle Health Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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?

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.

Conditions

• Hearing Disorder

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-06-02
• Primary completion: 2026-05-01
• Completion: 2026-07-01
• First posted: 2026-02-11
• Last updated: 2026-02-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study