United States: Imagine existing in a world where an incessant, piercing hum or ringing dominates every waking moment, and no matter what you do, it’s impossible to silence.
Over 25 million adults across the US endure this condition—tinnitus, as reported by the American Tinnitus Association. This condition not only overwhelms the mind but can also trigger intense anxiety, making it exceedingly difficult to handle. A myriad of causes contribute to the emergence of tinnitus, from auditory damage, noise exposure, or even viral infections, according to npr.org.
Although there is no definitive cure, a variety of techniques exist to mitigate its disruptive presence. From hearing aids to mindfulness therapies, these interventions can ease its grip, and now, a new FDA-sanctioned device is stepping into the spotlight: an apparatus designed to alleviate tinnitus through electrical stimulation of the tongue.
This innovation has notably benefited Victoria Banks, a singer-songwriter based in Nashville, Tennessee, who began grappling with tinnitus approximately three years ago.
“The noise inside my head resembled the constant drone of cicadas,” Banks recounted. “It was utterly terrifying.” The persistent sound disrupted her ability to sing and immerse herself in music. “It can completely paralyze you,” she admitted, according to npr.org.
Banks initially experimented with dietary supplements, to no avail. Upping her exercise routine offered no respite either. Then she stumbled upon Lenire, an FDA-approved device as of March 2023, which employs a mouthpiece outfitted with stainless steel electrodes that deliver electrical pulses to the tongue. Lenire is the first device of its kind cleared for tinnitus therapy.
“This had shown results for others, and by then, I was willing to try anything,” Banks recalls.
She sought the expertise of audiologist Brian Fligor, who specializes in treating severe tinnitus cases in the Boston area. Fligor had been impressed by a clinical study in which 84% of Lenire users experienced marked symptom improvement, which led him to adopt the device as a tool for his own patients. He also served as an advisor to the company that designed the device.
“A prime candidate for Lenire is someone who’s been living with tinnitus for at least three months,” Fligor noted, underscoring the importance of ruling out any underlying medical conditions beforehand, as mentioned by npr.org.
Tinnitus often correlates with hearing loss, yet Banks’ auditory function was intact, and no medical issues surfaced, making her an ideal candidate.
For 12 weeks, Banks utilized the device for an hour daily. During these sessions, the electrical stimulation produces a mild, tickling sensation on the tongue. Along with this, the device’s headphones play an assortment of tonal and ocean wave-like sounds.
Lenire operates by subtly diverting the brain’s attention from the incessant buzz. “Our brains naturally concentrate on critical incoming information,” Fligor explained. “Think of it like a spotlight focused on the most important detail on stage. When you’re distressed by tinnitus, that spotlight becomes intensely fixated on the noise.”
“The blend of neural stimuli on your tongue and auditory input creates a synchronous pattern that shifts this spotlight away from tinnitus,” Fligor elaborated.
“It releases that fixated attention,” he added, helping people become less sensitive to the noise their tinnitus generates, as per npr.org.
For Banks, the ringing hasn’t vanished completely, but it’s now hardly perceptible most days.
“It’s akin to living near a waterfall where the constant rushing sound gradually fades into the background,” she explains. Over time, her brain has adapted to concentrate on other stimuli, leaving the buzzing less intrusive. She’s back to her music—composing, performing, and listening. “I’m doing all of it again,” she proudly stated.
When the ringing resurfaces, a brief refresher session with the device is usually enough to keep it at bay.
A clinical trial showed that 84 percent of Lenire users reported significant improvements. Participants were assessed using a questionnaire that evaluated tinnitus’ impact on their sleep, sense of control, well-being, and overall quality of life. On average, after 12 weeks of use, their scores improved by 14 points.
“Lenire isn’t a silver bullet, but it’s become my go-to option for those unresponsive to other treatment methods,” Fligor admitted.
One downside is the cost. Banks invested around $4,000 in the Lenire device, which isn’t covered by insurance. She financed it using a credit card and gradually paid off the balance.
Fligor is hopeful that as more evidence of the device’s efficacy accumulates, insurance companies will eventually cover it. Despite the price, more than 80 percent of clinical trial participants said they would recommend the device to a friend with tinnitus.
However, questions remain about the duration of the benefits. Lenire’s trials have only tracked effects over one year. “We’re unsure how long the benefits last,” cautioned audiologist Marc Fagelson, who chairs the American Tinnitus Association’s scientific advisory board. While the results are encouraging, he insists more research is needed.
Fagelson always begins by evaluating his patients for hearing loss. Evidence suggests that for those experiencing both hearing loss and tinnitus, hearing aids can be a valuable treatment, particularly among older adults. Approximately one-third of adults aged 65 and older with hearing loss also experience tinnitus, according to npr.org.
“We’ve seen many patients with even mild hearing loss benefit from hearing aids,” Fagelson shared, though he estimates that about half of those cases show tinnitus improvement. Often, patients need to pursue additional treatment avenues.
Bruce Freeman, a research scientist at the University of Pittsburgh Medical Center, has found relief through both hearing aids and Lenire. He was fitted with Lenire in Ireland, where it was first available before it made its way to the US.
Freeman acknowledges that while the ringing never fully disappears, Lenire has helped him cope. The soundscapes delivered through the device are soothing and “almost hypnotic,” he says, and when combined with the tongue stimulation, the device desensitizes him to the ringing.
Freeman, who spent his career in research, is impressed by the positive findings, including a study in Nature Scientific Reports, which highlights significant improvements for trial participants with tinnitus.
Freeman’s symptoms worsened when he stopped using Lenire but improved again after he resumed.
He suspects that prolonged exposure to loud machinery in his lab, along with a neck injury from a cycling accident, contributed to his condition. “All these factors collided,” he said.
Freeman has adopted several lifestyle changes to manage his tinnitus, such as swimming, which he finds remarkably helpful. “The swishing of water in my ears is a form of mindfulness,” he explained, as per npr.org.
When it comes to tinnitus, Freeman acknowledged, “It comes and goes.” For now, the persistent ring has faded into the background, giving him much-needed respite. “The last two years have been fantastic,” he said, thanks to the device, hearing aids, and mindfulness.
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