Bimodal stimulation, or bimodal neuromodulation, is a relatively new treatment for tinnitus that involves combining sound stimulation and somatosensory stimulation (i.e. touch) to alleviate the tinnitus. This treatment is based on the idea that stimulation both the auditory and non-auditory parts of the brain can help reduce the perception of tinnitus.
Tinnitus effects an estimated 10% of the U.S. population – over 25 million Americans. Most people with significant tinnitus report difficulty with sleep, concentration, increased anxiety and depression.
How does bimodal stimulation work?
Bimodal stimulation works by using a device that delivers sound to the ears through headphones while simultaneously delivering mild electrical stimulation to an area of the body. The sound and somatosensory stimulation are synchronized to create a specific pattern of stimulation that is designed to stimulate the brain and reduce the severity of tinnitus.
Why use somatosensory stimulation in the treatment of tinnitus?
Stimulating somatosensory nerves and auditory nerves at the same time to treat tinnitus is based on the idea that stimulation of these two nerve systems (bimodal) encourages more neuroplasticity of the brain. Neuroplasticity is a change or rewiring in the brain and can lead to a reduction in the brain’s attention and sensitivity to the tinnitus sound.
Studies have shown that somatosensory stimulation can have a variety of effects on the brain, including reducing neural activity in certain regions, increasing the release of neurotransmitters, and increasing blood flow to the brain. We already know that delivering auditory sounds, via sound therapy, to the brain can help reduce tinnitus. By also delivering somatosensory stimulation to patients with tinnitus, it is believed that this can help to retrain the brain’s response to the tinnitus sounds and reduce the perception of tinnitus.
There are currently 3 devices that use bimodal stimulation as a treatment for tinnitus.
1. Neuromod’s Lenire Device
As of March 2023, the Lenire device was granted De Novo approval to treat tinnitus in the U.S. by the FDA. This is following the success of a third large scale clinical trial, the TENT-A3 trial, that evaluated the effectiveness of the Lenire device for treating tinnitus. The 112-patient pivotal TENT-A3 clinical trial supported by confirmatory Real-World Evidence from 204 patients confirmed the impressive results of the Lenire device, as shown from their TENT-A1 and TENT-A2 clinical trials.
In the TENT-A3 trial, 79.4% of treatment compliant patients showed a clinically significant improvement in the severity of their tinnitus in only 6 weeks. With this result, Lenire has now been shown to be more effective than sound therapy alone, which is the current method of tinnitus treatment being used.
Overall, the TENT-A3 study provides evidence that the Lenire device can be an effective treatment option for individuals with chronic tinnitus. Lenire will be available for Americans suffering with tinnitus starting in April 2023.
The Lenire device consists of 3 parts:
- Headphones to deliver the auditory stimulus to the ears
- Tonguetip which delivers small electrical impulses to the top of the tongue
- Controller which is used to adjust the treatment intensity and duration
It is recommended that the Lenire device be used 60 minutes per day (in two 30-minute increments).
Here are some important things to know about this device:
- How it works: The Lenire system uses a combination of sound and electrical stimulation to the tongue to treat tinnitus. The device delivers customized sound therapy through headphones and gentle electrical stimulation through electrodes placed on the tongue.
- Clinical trials: The Lenire system has been tested in several clinical trials, and has been shown to be safe and effective in reducing the symptoms of tinnitus.
- Prescription required: The Lenire system is a prescription-only device, which means that patients must see a healthcare provider specializing in tinnitus to use it.
- Cost: The cost of the Lenire system is not yet clear, but it is expected to be in line with other bimodal stimulation devices currently on the market.
- Availability: “Following the FDA’s granting of approval, Neuromod will train audiologists and ENTs specializing in tinnitus care with the intention of treating the first tinnitus patients based in the USA as soon as April 2023.”
- Effectiveness: The Lenire system has shown promise in clinical trials, with confirmation through real-world efficacy studies, in improvement in the severity of the patients’ tinnitus.
Overall, the FDA approval of the Lenire system represents an important step forward in the treatment of tinnitus, and may offer a new and effective option for patients suffering from this condition. However, as with any new treatment, it’s important for patients to work closely with a healthcare provider to determine whether this is the right treatment approach for their specific needs and circumstances.
If you would like to be notified of when the Lenire device is available to you through Dr. Hearing Loss, sign up for the waitlist using the form below to get on my email list.
2. Neosensory Duo
The Neosensory Duo device uses a combination of sound and vibration stimulation delivered through a smartphone app and a wristband. It is currently available for use in the U.S.
A recent study published in the International Tinnitus Journal showed promising results with the Neosensory Duo users who had moderate to severe tinnitus. 94% of the Neosensory Duo users reported improvements in their tinnitus after using the device for 8 weeks. They used a questionnaire called the Tinnitus Functional Index (TFI) showing users of the device (wristband and tones) showed an average reduction of 21.8 points, which is considered to be clinically significant.
Here are some things you should know about the Neosensory Duo:
- How it works: The Neosensory Duo uses a patented wristband that creates specific vibrational patterns on the skin. The wristband is synchronized with tones played in a frequency range individualized to the user’s tinnitus. It is recommended to use the device for at least 10 minutes/day for 8 weeks.
- Clinical trials: The recent study showed that the Neosensory Device was effective in reducing symptoms of tinnitus in users with moderate to severe tinnitus.
- Prescription required: No. You can purchase the Neosensory Duo on the manufacturer’s website or from some local providers.
- Cost: The device is recommended to be rented from the Neosensory website for $249.00 per month for 2 months.
- Availability: The Neosensory Duo device is available for purchase in the U.S.
- Effectiveness: While the Neosensory device has shown promise in clinical trials, it is important to note that not all patients may respond to the treatment in the same way, and the effectiveness of the treatment may depend on factors such as the severity and duration of the tinnitus, as well as the individual’s age and overall health. The Neosensory Duo is not FDA approved for the treatment of tinnitus at this time.
Neosensory Duo may have potential as a treatment option for some patients with chronic tinnitus. However, more research is needed to fully understand the effectiveness of this treatment, and to identify which patients may benefit most from this approach.
If you would like a code for $25 off/month for up to four months ($100 off the cost if you purchase the device), sign up for my email list below.
3. Susan Shore’s Michigan Tinnitus Device from Auricle Inc.
The Michigan Tinnitus Device, said to be marketed as the Auricle when available to the public, delivers auditory stimulation via headphones set around the frequency of the user’s tinnitus, as well as somatosensory stimulation via electrical impulses through electrodes placed on the face or neck.
The device developed by Susan Shore for tinnitus treatment is called the “bimodal auditory-somatosensory stimulation device,” which is also known as the “neuromodulation device.” It is designed to deliver both auditory and somatosensory (touch) stimulation to the patient, with the goal of retraining the brain’s response to tinnitus sounds.
A recent clinical trial looked at the effectiveness of device for those with somatic tinnitus. Somatic tinnitus. Somatic tinnitus is tinnitus that is able to be modified by movements on the neck or jaw. The results showed a clinically significant reduction in Tinnitus Functional Index (TFI) score and a more impressive 75% reduction in tinnitus loudness by 12 weeks. The device has shown promise in studies but more research is needed to fully understand its effectiveness and potential benefits for patients with tinnitus.
Here are some things you should know about the Michigan Tinnitus Device:
- How it works: The treatment utilizes a stimulus protocol consisting of precisely timed sounds delivered through headphones, alternated with weak electrical pulses to the neck or head that activate touch-sensitive nerves.
- Clinical trials: The recent study showed that Susan Shore’s Tinnitus Device was effective at reducing TFI scores and perceived tinnitus loudness in those with somatic tinnitus.
- Prescription required: It is likely going to be distributed through audiologists and health professionals as tinnitus testing is needed prior to use to target the user’s tinnitus frequencies.
- Cost: The potential device cost is unknown.
- Availability: The device is not yet available for purchase. Auricle Inc. is working to get FDA approval but no timeline has been mentioned.
- Effectiveness: Once the device is on the market, there will be more “real-world” studies performed to address its efficacy.
The Pros of Using Bimodal Stimulation as a Treatment for Tinnitus
Bimodal stimulation, or bimodal neuromodulation, has several potential benefits as a treatment for tinnitus, including:
Customization
Bimodal stimulation devices can be customized to each individual’s specific tinnitus symptoms and needs, which may increase the effectiveness of the treatment.
Non-invasive
Bimodal stimulation is a non-invasive treatment that does not require surgery or medication, which may make it more appealing to some people.
Low risk
The risks associated with bimodal stimulation are generally considered to be low, and side effects are usually mild and temporary.
Potential for long-term relief
Some studies suggest that bimodal stimulation may provide long-term relief from tinnitus symptoms.
Combined approach
Bimodal stimulation combines two different types of stimulation (auditory and somatosensory) to target both the auditory and non-auditory parts of the brain that are involved in tinnitus perception.
Overall, bimodal stimulation shows promise as a potential treatment for tinnitus, and may offer several advantages over other treatment options.
Cons of Bimodal Stimulation as a Treatment for Tinnitus
While it has potential benefits, there are also some potential drawbacks or limitations, including:
Cost
Bimodal stimulation devices can be expensive, and may not be covered by insurance.
Limited availability
Bimodal stimulation is not yet widely available, and may only be available in certain areas or through certain healthcare providers.
Lack of long-term data
While some studies suggest that bimodal stimulation may provide long-term relief from tinnitus symptoms, more research is needed to confirm this, and the long-term effects of this treatment are not yet fully understood.
Individual variability
Not all patients may respond to bimodal stimulation in the same way, and the effectiveness of the treatment may depend on factors such as the severity and duration of the tinnitus, as well as the individual’s age, hearing loss and overall health.
Potential side effects
While the risks associated with bimodal stimulation are generally considered to be low, some patients may experience mild side effects such as headaches, dizziness, or tingling sensations.
Overall, while bimodal stimulation shows promise as a potential treatment for tinnitus, it is important for patients to carefully consider the potential benefits and drawbacks of this treatment, and to work closely with a healthcare provider to determine whether this is the right treatment approach for their specific needs and circumstances.
If you experience tinnitus and are seeking out a treatment, the important thing is that you don’t wait. Research in treatment is ongoing and different solutions work for different people. Help is available now through other methods of treatment such as sound therapy and counseling. If you would like to discuss tinnitus treatment options available to you right now, schedule a free tinnitus consult with me using the button below.
Schedule Appointment
Leave a Reply