Brain Science:
25 million Americans are suffering from ringing in the ears. I have been listening to the ringing for over 25 years. Tinnitus (ringing in the ears) is a complex neurological condition that causes a perception of sound when there is no external source. There is at the present time no known cure for the Tinnitus. However, as of March 7 there is a treatment! The FDA in March approved Lenire's Neuromed Devices as a treatment. It is the first neuromodulation device approved by FDA.
What the heck is neuromodulaion? Well it seems we come up with new words every day . In this case neuromodal means both sound and taste. The device is one that plays sounds into your ears and at the same time delivers a slight electrical impulse to the tongue. right? I saw something on this a year or so ago and felt this was way out. Well evidently not it is not so far out... if the government (FDA) is now approving it. The food and drug administration is a very conservative agency. The FDA approval is based on the success of a large 3rd scale clinical trial. You may recall that there are generally three trials required and at any one the process can stop. 79.4% of study patients experienced a clinically significant improvement. 88.6% responded that they would recommend the tinnitus treatment. The study also differentiated between just the sound treatment and the tongue stimulation. With the bimodal sound and tongue stimulation performing clinically meaningful improvement over sound alone.
There is now a company that makes neuromod devices. The company , Neuromod Devices Limited, is located in Dublin, Ireland. The technology includes three parts: Bluetooth headphones, that play custom sounds to the ear to activate the auditory nerve, a device to attach to the tongue that activates nerves by sending a mild stimulation to the surface of the tongue, and a controller that allows for adjustment of the duration and intensity of treatment. The sound tongue stimulations are worked together to reduce patients tinnitus severity.
The treatment is individually tailored by a audiologist, specialist audiologists called otolaryngologists and ENT surgeons. The studies have used both a six week treatment and 12 week treatment regimen. Both have shown significant improvement. The Lenire tinnitus treatment program is considered completely non invasive. Lenire is the first bimodal neuromodulation device to go through the rigors of the FDA's new process.
Brain Facts:
One of the demographics prone to tinnitus are veterans, 2.7 million former military members are living with tinnitus.
It is estimated that the Department of Veterans Affairs paid out more than $4.9 billion through its Veterans Compensation program for tinnitus alone in 2022.
Approximately 1/3 of adults report some form of tinnitus.
95% of patients that completed 12 weeks of treatment reported improvement in the severity of treatment.
The foundation principle that new treatments for Tinnitus depends on, is that of the placity of the Brain. As we know the brain has the ability to repair itself by creating new pathways of signals associated with sensing and thought. This plasticity makes the brain the most versatile organ in the body.
Tinnitus is a symptom, not a disease. Researchers believe the noises people hear inside the head are the brain’s reaction or way of adapting to some sort of damage in the ear. Tinnitus is sometimes, but not always, accompanied by hearing loss, which is why it is especially common among senior citizens.
So What :
All of this is new in terms of deployment and dissemination of information. Since the approvals on March 7, the companies have been in the process of training, setting up distribution networks and logistical issues through a new network of audiologists, ENT surgeons etc. The treatment plan consists of an assessment first of the suitability of a patient for treatment. After the assessment a portion of the program can be completed at home with monitoring visits with the clinician.
As mentioned, I have had tinnitus for over 30 years. I have sent in a request to be put on a list for possible treatment. A few clinics in Indianapolis have been listed as possible patient centers. I have tried to contact them also. At this point the only response has been the acknowledgement that I am on a list.
There are still, as you would expect, a lot of questions out there. What is the cost? Will the VA cover it? How long will it take to set up treatment networks? What kind and form will there be to quality control? (Remember this is non invasive and therefore may be more susceptible to unscrupulous mimics. I remember the silver belts we were wearing that were going to melt the fat away!)
If you would like I can keep you informed about progress if follow up contacts are accomplished.
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