Clinical FDA considers clearance for neuromodulation device as Tinnitus treatment

FDA considers clearance for neuromodulation device as Tinnitus treatment


The FDA is considering granting de novo clearance for a device aimed at treating tinnitus, a condition characterized by persistent ringing in the ears that affects approximately 15% of the population. The device, developed by Neuromod Devices, is designed to deliver sound patterns through headphones to stimulate specific regions of the brain and reduce the symptoms of tinnitus.

According to a summary of the FDA’s findings, the device has been tested in two randomized clinical trials involving more than 500 participants, with positive results. In one study, 326 patients reported a statistically significant reduction in tinnitus symptoms after using the device for 60 minutes per day for 12 weeks. The second trial, which involved 179 patients, showed that 86% of participants reported a reduction in symptoms.

The FDA is currently soliciting feedback on whether the device should be granted clearance. This process allows novel medical devices to be cleared for sale without a predicate device. If cleared, the device could offer a non-invasive and potentially effective treatment option for tinnitus sufferers.

Tinnitus can be caused by a variety of factors, such as repeated exposure to loud noises, age, or some medications. Currently, there is no cure for tinnitus, and treatment options are limited. Some patients may benefit from hearing aids or cognitive behavioral therapy, but many do not respond to these treatments.

Neuromod’s device represents a new approach to tinnitus treatment, using targeted sound stimulation to modulate activity in the brain. The device is designed to deliver customized sound patterns based on each patient’s individual tinnitus profile, with the goal of reducing the perception of the ringing in the ears.

A neck and head surgery professor, Steven Cheung said, “The otolaryngologist now has access to innovative Lenire technology and can prescribe it to patients who are at least moderately impacted by their tinnitus. The majority of these tinnitus patients are either inadequately relieved or are opting not to pursue existing options, such as hearing aids.”

The device has been available in Europe since 2020, where it has been granted CE Mark certification. If granted de novo clearance in the U.S., it would be the first non-invasive neuromodulation device cleared for the treatment of tinnitus.

In addition to its potential as a treatment for tinnitus, the device could also have broader applications in the field of neuromodulation. Neuromod Devices is currently exploring the use of the device in other neurological conditions, including chronic pain, stroke rehabilitation, and cognitive impairment.

Neuromod Devices’ novel device for tinnitus treatment is currently under consideration for de novo clearance by the FDA, offering a potentially effective and non-invasive treatment option for tinnitus sufferers. 

With positive results in randomized clinical trials that involved more than 500 participants, the device employs targeted sound stimulation to modulate brain activity, presenting a fresh perspective to tinnitus treatment. In addition, this innovative device may have broader implications in the realm of neuromodulation, providing new treatment opportunities for other neurological conditions.

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