Electrical Stimulation for Hearing Loss
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether short electrical signals can be heard during ear surgery, focusing on procedures that expose the middle ear. The study aims to determine if these signals, known as electrical extracochlear stimulation, assist in distinguishing different sounds. Individuals already scheduled for such surgery, without long-term or congenital hearing loss, may qualify. However, those with recent ear infections or major head trauma are not eligible. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research in auditory science.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this electrical stimulation is safe for hearing loss?
Research has shown that electrical extracochlear stimulation, a method tested for hearing loss, is generally safe. Studies have found that this type of electrical stimulation does not worsen hearing over time.
While the specific treatment in this trial is not yet approved, similar electrical methods are safely used in cochlear implants for individuals with severe hearing loss. These implants send electrical signals to the ear to aid hearing. So far, no major safety issues have been reported with this kind of stimulation.
Overall, existing evidence suggests that electrical extracochlear stimulation is well-tolerated by most patients.12345Why are researchers excited about this trial?
Unlike standard treatments for hearing loss, which often involve hearing aids or cochlear implants, electrical extracochlear stimulation offers a novel approach by directly stimulating the ear. This method uses electrical signals to potentially improve hearing without the need for invasive surgery or external devices. Researchers are excited about this technique because it could lead to more natural sound perception and be a less invasive option for patients with hearing loss.
What evidence suggests that electrical extracochlear stimulation is effective for hearing loss?
Research shows that electrical signals stimulating the hearing nerve can help with hearing issues. This trial will investigate electrical extracochlear stimulation, which might alleviate tinnitus, a condition characterized by hearing ringing or noise that isn't present. In some studies, nearly half of the participants experienced reduced ringing loudness after this treatment. Additionally, using electrical signals in the ear has improved speech understanding, especially in noisy environments, suggesting potential benefits for hearing loss. These findings offer hope for using this technique in hearing-related conditions.36789
Are You a Good Fit for This Trial?
Adults over 18 who are already scheduled for awake ear surgery that exposes the middle ear can join this trial. They must be willing to undergo extra tests during their surgery to see if they can hear short electrical signals.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgery and Stimulation
Participants undergo middle ear surgery with electrical stimulation and psychoacoustic testing
Follow-up
Participants are monitored for any new sensations or discomfort experienced during the stimulation
What Are the Treatments Tested in This Trial?
Interventions
- Electrical extracochlear stimulation
Trial Overview
The study is testing whether people can accurately hear different pitches when given short bursts of electrical stimulation in the ear during surgery. This could help understand hearing loss better.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Electrical extracochlear stimulation and psychoacoustic testing
Find a Clinic Near You
Who Is Running the Clinical Trial?
Auricle Health Inc.
Lead Sponsor
The Cleveland Clinic
Collaborator
Citations
Systematic Review on Intra- and Extracochlear Electrical ...
Electrically stimulating neurons of the auditory nerve enables targeting the auditory pathway and thus may counteract tinnitus origins. This can ...
Electrical Ear Canal Stimulation as a Therapeutic ...
Results: After three days of electrical stimulation, tinnitus loudness decreased in 47% of patients, 45.5% reported no change, and 7.6% reported worsening.
Effect of reducing electrical stimulation rate on hearing ...
Reducing the stimulation rate from 900 pps/ch to 500 pps/ch did not compromise the hearing outcomes evaluated in this study.
Electro-vibrational stimulation results in improved speech ...
We demonstrate a statistically significant and clinically relevant improvement for speech perception in noise of 1.9 dB signal-to-noise ratio.
Evaluation of Cochlear (Promontory) Stimulation During ...
The goal of this interventional clinical study is to investigate the feasibility for minimally invasive electrical stimulation of the cochlea as ...
Electrical stimulation of the cochlea for treatment of chronic ...
In other words, isolated chronic electrical stimulation of the cochlea does not appear to accelerate hearing loss compared to the non- ...
Summary of Safety and Effectiveness Data (SSED)
A Cochlear Nucleus Cochlear Implant (CI) is not suitable for individuals with the following conditions: • Absence of cochlea development. • ...
Consequences of chronic extracochlear electrical ...
This investigation examined the consequences of neonatal deafness and chronic electrical stimulation of the cochlea in the developing auditory system.
Nucleus® cochlear implants
These individuals typically have moderate to profound hearing loss in the low frequencies and profound (≥90 dB HL) hearing loss in the mid to high speech ...
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