An FDA approved device offers a new treatment for ringing in the ears : Shots

An FDA approved device offers a new treatment for ringing in the ears : Shots

Victoria Banks Finds Relief with Lenire Device

Victoria Banks reports a significant improvement in her tinnitus after consistently using the Lenire device for one hour daily over a span of 12 weeks.

Victoria Banks – Image Credit: David Petrelli

Imagine enduring a constant high-pitched buzzing or ringing in your ears, a sensation that just won’t go away.

According to the American Tinnitus Association, over 25 million adults in the United States suffer from tinnitus, a condition that can be distressing, even leading to panic and proving challenging to cope with. Various factors such as hearing loss, exposure to loud noises, or even a viral infection can trigger tinnitus.

While there is no definitive cure for tinnitus, there are treatments available, including the FDA-approved Lenire device.

There exist various approaches to alleviate tinnitus symptoms, such as utilizing hearing aids, practicing mindfulness therapy, and exploring a novel solution – a FDA-approved device that employs electrical stimulation on the tongue.

Victoria Banks, a musician from Nashville, Tennessee, who encountered tinnitus three years back, found relief with the device. Describing the ringing in her ears as reminiscent of cicadas, Banks expressed how distressing it was. The constant buzzing impeded her ability to sing and enjoy music, causing significant challenges.

In an attempt to address her condition, Banks experimented with the FDA-approved tinnitus treatment.

Revolutionizing Tinnitus Treatment with FDA-Approved Device

Victoria Banks tried various dietary supplements and increased her exercise routine to alleviate her tinnitus symptoms, but to no avail. Desperate for relief, she discovered Lenire, an innovative device approved by the FDA in March 2023. This groundbreaking device consists of a plastic mouthpiece equipped with stainless steel electrodes that provide electrical stimulation to the tongue, marking a significant advancement in tinnitus treatment.

Upon learning about the success stories of others, Banks decided to explore this new treatment option. She consulted audiologist Brian Fligor, renowned for treating severe tinnitus cases in Boston. Impressed by the outcomes of a clinical trial revealing that 84% of participants experienced a notable decrease in symptoms after using Lenire, Fligor became an early adopter of the device in the U.S. He also contributed his expertise to an advisory panel established by the device’s developers.

According to Fligor, individuals who have been dealing with tinnitus for a minimum of three months are ideal candidates for the device. He emphasizes the importance of undergoing an evaluation to rule out any underlying medical conditions before commencing treatment.

While tinnitus commonly coexists with hearing loss, Banks, with her intact hearing and absence of other medical issues, was deemed a suitable candidate for the device. She embarked on a treatment journey leveraging the FDA-approved tinnitus treatment, Lenire, to find relief from her symptoms.

### Using FDA Approved Tinnitus Treatment for 1 Hour Daily

In a 12-week period, participants engage in hour-long sessions of electrical stimulation on the tongue, accompanied by soothing tones and ocean-wave sounds through headphones.

The treatment method diverts the brain’s attention from the tinnitus, a natural response to prioritize crucial information. This shift is likened to a spotlight on stage, focusing on the most significant element. When experiencing tinnitus-related emotions like frustration or fear, this spotlight intensifies on the tinnitus itself.

The combined sensory input from the tongue and ears, working in harmony, helps reduce the brain’s fixation on the tinnitus. Clinical trials have shown an 84% success rate in symptom reduction with this FDA approved tinnitus treatment.

Effectiveness of FDA Approved Tinnitus Treatment

In a recent clinical trial, it was discovered that 84% of individuals who utilized the device experienced a notable decrease in symptoms.

According to Brian Fligor, the device “unsticks your spotlight” and aids in desensitizing individuals to the perceived noise caused by their tinnitus.

An example of the device’s impact is seen in Banks’ experience, where the ringing in her ears, although not completely eradicated, has become barely noticeable on most days.

She describes the effect as akin to living near a constant waterfall, where over time, the sound of the waterfall fades into the background of consciousness.

With her brain now focusing on other activities, the buzzing is no longer as distracting, allowing her to engage in music-related pursuits once again.

When the buzzing becomes prominent again, Banks finds that a refresher session with the device proves beneficial.

The clinical trial also revealed that 84% of Lenire users experienced significant enhancements in their condition. Participants reported improvements in sleep quality, sense of control, well-being, and overall quality of life after 12 weeks of device usage.

Fligor emphasizes that while the device is not a universal solution, it has become a preferred option for individuals who have not responded to other tinnitus management methods.

However, one drawback is the cost associated with the device, with Banks personally paying around $4,000 for the Lenire device as insurance does not cover it. She opted to gradually pay off the expense using her credit card.

Fligor remains optimistic that as more evidence of the device’s effectiveness emerges, it will become a more widely accepted FDA approved tinnitus treatment.

Insurers Begin Covering FDA-Approved Tinnitus Treatment

Over 80% of participants in the clinical trial for the FDA-approved tinnitus treatment expressed willingness to recommend the device to friends, despite potential costs.

While the effectiveness of the treatment is promising, its long-term benefits remain uncertain. Clinical trials have only assessed Lenire’s impact over a one-year period, leaving questions about the durability of its effects. According to Marc Fagelson, an audiologist and the chair of the American Tinnitus Association’s scientific advisory committee, ongoing research aims to uncover more about the treatment’s lasting effects.

When evaluating patients with tinnitus, Fagelson emphasizes the importance of assessing hearing loss first. Studies indicate that hearing aids can effectively alleviate tinnitus in individuals with both conditions, a common occurrence among older adults. Approximately one-third of adults aged 65 and above with hearing loss also experience tinnitus.

While hearing aids benefit many patients with tinnitus, Fagelson notes that only about half of them see improvement in their tinnitus symptoms. This suggests that alternative treatments may be necessary for some individuals beyond using hearing aids.

Personal Experience with FDA-Approved Tinnitus Treatment

Bruce Freeman, a researcher at the University of Pittsburgh Medical Center, has found relief from tinnitus through a combination of hearing aids and Lenire. Freeman, who received the device in Ireland before its U.S. release, acknowledges that the ringing associated with tinnitus persists but credits the treatment with helping him manage the condition. He describes the sounds emitted by the device as soothing and almost hypnotic, especially when combined with tongue vibration.

The Impact of FDA Approved Tinnitus Treatment

Research scientist Freeman expresses his admiration for the outcomes of studies, such as one featured in Nature, Scientific Reports, which highlights significant enhancements in tinnitus symptoms among participants in clinical trials.

Upon discontinuing the use of the treatment device, Freeman noticed a resurgence of his tinnitus symptoms. He emphasizes that the absence of the device led to a deterioration in his condition, while its reintroduction resulted in an improvement.

Attributing his tinnitus to prolonged exposure to loud equipment in his research facility and a neck injury from a bicycle accident, Freeman acknowledges the convergence of these factors in contributing to his condition.

Implementing various strategies to manage his tinnitus and maintain overall well-being, Freeman underscores the benefits of swimming, noting the calming effect of the water’s sound in his ears as a form of mindfulness.

Reflecting on his tinnitus journey, Freeman describes the fluctuating nature of the condition, stating that currently, it has receded into the background, bringing him a sense of relief. He credits the past two years of improvement to a combination of the treatment device, hearing aids, and the mindfulness cultivated through swimming.

This article was revised by Jane Greenhalgh

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