Vagus Nerve Stimulation for Age-Related Hearing Loss

Overseen By Tracy Centanni, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Must not be taking: Neurotransmitter medications

Disqualifiers: Brain injury, Heart conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to assist individuals with age-related hearing loss, particularly in understanding speech in noisy environments. The study tests a treatment called transcutaneous auricular vagus nerve stimulation, which involves gentle electrical stimulation on the ear, to determine if it can improve speech comprehension amid background noise. Individuals with age-related hearing loss who struggle in noisy settings might find this trial relevant. Participants should not have a history of brain injury or implanted medical devices. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance hearing in challenging environments.

Will I have to stop taking my current medications?

The trial requires that you stop taking medications that affect neurotransmitters (chemicals in the brain) released by vagus nerve stimulation.

What prior data suggests that this technique is safe for improving speech perception in noise for age-related hearing loss?

Research has shown that transcutaneous auricular vagus nerve stimulation (taVNS) is generally safe for people. A review of multiple studies found that taVNS can be safely used in medical settings. In these studies, patients mostly experienced minor side effects, such as mild skin irritation where the device was applied. This indicates that taVNS is well-tolerated for various conditions, including mild memory problems and chronic sleep issues.

Although the FDA has not yet approved taVNS specifically for age-related hearing loss, its safety in other areas suggests potential usefulness in this trial. Researchers are studying this treatment as a way to help with hearing difficulties, especially in noisy environments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for age-related hearing loss, such as hearing aids or cochlear implants, transcutaneous auricular vagus nerve stimulation (taVNS) targets the nervous system directly. Researchers are excited about this treatment because it involves stimulating the vagus nerve through the skin of the ear, potentially enhancing the brain's ability to process sound in noisy environments. This approach is non-invasive and could offer an innovative alternative for improving auditory function without the need for surgery or external devices.

What evidence suggests that transcutaneous auricular vagus nerve stimulation is effective for age-related hearing loss?

Research shows that transcutaneous auricular vagus nerve stimulation (taVNS), a treatment participants in this trial may receive, might help with hearing and related issues. Studies have found that taVNS can assist people with tinnitus, a condition characterized by hearing ringing without external sound. This suggests it might also improve hearing in noisy environments. In older adults, taVNS has been linked to early signs of cognitive decline, often associated with hearing loss. Additionally, taVNS has shown benefits for mood and sleep, enhancing overall quality of life. These findings suggest taVNS could help people with age-related hearing loss understand speech better in noisy settings. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for adults aged 55-80 who have normal hearing or age-related hearing loss, which may include those using hearing aids. It's not suitable for individuals with a history of traumatic brain injury, noise trauma, heart conditions, implanted medical devices like pacemakers, or those on medication affecting neurotransmitters related to vagus nerve stimulation.

Inclusion Criteria

I am between 55 and 80 years old.

My hearing is normal or I have age-related hearing loss.

Exclusion Criteria

History of traumatic brain injury or noise trauma

Implanted medical devices (eg., pacemaker) or ferrous metal

I have a history of heart conditions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive taVNS or control stimulation for improving speech in noise perception

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sham Control
• transcutaneous auricular vagus nerve stimulation

Trial Overview The study tests transcutaneous auricular vagus nerve stimulation (taVNS) against a sham control to see if it can improve the ability to understand speech in noisy environments for people with age-related hearing loss.

How Is the Trial Designed?

Group I: Treatment A Experimental Treatment 1 Intervention

participants will receive low level electrical stimulation to the auricular branch of the vagus nerve during the sound in noise task

Group II: Treatment B Active Control 1 Intervention

Participants will receive stimulation to a control location

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Citations

1. nature.com nature.com/articles/s41598-025-11363-6

Transcutaneous auricular vagus nerve stimulation ... - Nature This study highlighted early markers and intervention points for cognitive decline with a specific emphasis on hearing loss in older adults as a ...

2. frontiersin.org frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2024.1405310/full

Current status of transcutaneous auricular vagus nerve ... taVNS shows promise as a therapy for tinnitus, and treatment protocols should be optimized in future clinical trials.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1935861X22002078

The efficacy and safety of transcutaneous auricular vagus ... This randomized controlled trial involved patients with MCI, aged from 55 to 75 years old. Patients were randomly allocated to transcutaneous auricular vagus ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2828072

Transcutaneous Auricular Vagus Nerve Stimulation for ... This randomized clinical trial investigates the efficacy and safety of transcutaneous auricular vagus nerve stimulation (taVNS) for chronic insomnia.

5. aging-us.com aging-us.com/article/102074/text

Effects of transcutaneous vagus nerve stimulation in ... Two weeks of daily tVNS improved measures of autonomic function, and some aspects of QoL, mood and sleep.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9772204/

Safety of transcutaneous auricular vagus nerve stimulation ... This is the first systematic review and meta-analysis of transcutaneous auricular stimulation safety. Overall, taVNS is a safe and feasible option for clinical ...