The more we learn about tinnitus, the more we see the complex ways in which the symptoms can present themselves. These symptoms can impact every part of daily life, whether that’s falling/staying asleep, working, or socializing with your loved ones. Tinnitus can also trigger psychological symptoms such as anxiety and feelings of depression, which for some, can worsen existing mental health problems and feelings of distress.
As the community of tinnitus patients grows, more research is being conducted to bring us one step closer to the cure we all hope for. So far, the market has been flooded with products and devices that promise to stop the ringing in the ears, with some showing promise, and others, where the science is lacking.
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"As a recent graduate who’s achieved stage four habituation, I cannot thank Treble Health enough for getting me to the finish line."
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Sound Pharmaceutics hopes to produce the world’s first tinnitus drug approved by the Food and Drug Administration (FDA). Could this be the ray of hope the millions of Americans who have tinnitus hope for? We’ll explore the science behind SPI-1005 to see what this drug could potentially mean for the future of treating tinnitus. We’ll also explore some other experimental treatment options that could have a meaningful impact on the phantom sounds in the ears.
What is SPI 1005?
SPI-1005 was originally developed to treat Ménière’s disease, a condition characterized by fluctuating hearing loss, tinnitus (ringing/buzzing in the ears), ear fullness and episodic vertigo. Typically affecting those between 40 and 65 years old, the condition involves abnormal fluid buildup in the inner ear related to inflammation and oxidative stress in the auditory system. This buildup can disrupt the delicate cochlea, an inner ear structure responsible for translating sound vibrations into nerve signals for the brain to interpret. The result is the brain receiving faulty or excessive signals.
SPI-1005 is an oral pill developed by Sound Pharmaceuticals to target inflammation and oxidative stress in the inner ear. It is the first investigational drug designed to treat inner ear disorders by targeting the glutathione pathway. It is also the longest treatment trial involving an investigational drug for hearing loss and tinnitus.
The drug contains the active ingredient, ebselen, a synthetic compound that mimics and induces glutathione peroxidase (GPx), an enzyme with anti-inflammatory and antioxidant properties. This compound has also been found to be very effective in reducing neuroinflammation across the Central and Peripheral nervous system.
SPI-1005’s ingredients are critical for several cell types and tissues such as those found in the inner ear, retina, and lungs. This can potentially help to protect the hair cells and nerve structures in the cochlea. It is also believed to be able to treat patients with hearing loss, specifically noise-related hearing loss, and hearing-loss due to ototoxicity.
Following the promising results of the earlier Phase 1b and 2b clinical trials, Phase 3 trials began in August 2022 and ended in July 2024. It involved 221 eligible patients who received either SPI-1005 or a placebo. According to the press release, the Phase 3 study demonstrated that SPI-1005 had significantly reduced vertigo frequency, improved patient-reported outcomes for hearing and tinnitus in individuals with Ménière’s disease. The U.S. FDA has also granted Fast Track Designation to SPI-1005, meaning a faster development and review process to get it to patients sooner.
SPI 1005 and Tinnitus
Tinnitus is one of the hallmark symptoms of Ménière’s disease. Oxidative stress has also been known to lead to tinnitus symptoms. The research suggests that SPI-1005’s antioxidant and anti-inflammatory properties could potentially benefit those with tinnitus patients, even those that don’t have Ménière’s disease.
There’s still a lot left to learn about tinnitus and its mechanism. Some research suggests tinnitus is caused by hyperactivity along the auditory pathway. This can be caused by factors such as hearing loss, trauma, and inflammation. By addressing both neural activity and reducing the stress within auditory pathways, SPI-1005 may help regulate the way the brain processes sound. But, further funding into tinnitus research is needed to give us more answers.
SPI-1005 offers hope to patients who deal with chronic tinnitus symptoms. However, it should be noted that while this drug may work for Meniere’s disease, it is not guaranteed to treat all cases of tinnitus. Tinnitus symptoms have many root causes, and will require different treatment approaches. For example, SPI-1005 wouldn’t be able to cure tinnitus caused by ear blockage, or a vestibular schwannoma (also known as an acoustic neuroma) which would require physical intervention.
Reducing oxidative stress
SPI-1005 isn’t available for patients yet. Luckily, there are ways to reduce oxidative stress as part of a tinnitus treatment plan, outside of this potential pharmaceutical intervention. Some ways we can minimize our exposure to factors that increase oxidative stress include:
- Reducing/quitting smoking- Most people smoke to relax and relieve stress, but there’s another equally harmful type of stress that often goes unnoticed. Tobacco is a major source of free radicals, which can lead to oxidative stress.
- Limiting alcohol consumption- Excessive alcohol consumption has been known to increase oxidative stress and reduce liver function. Drinking in moderation can significantly reduce oxidative stress and contribute to overall well-being.
- Eating less processed foods- Processed food is a huge culprit of oxidative stress in the body, especially those containing trans fats, artificial additives, and certain preservatives. People are encouraged to stay hydrated, and eat whole foods to help flush out toxins and waste, and support the body’s defense against oxidative stress.
- Avoiding loud noise exposure- Wearing ear plugs or ear muffs in environments with loud noises over 85 decibels is recommended to reduce oxidative damage that may occur in the inner ear.
Other experimental/alternative treatments
Tinnitus Retraining Therapy (TRT) is considered the gold standard treatment for tinnitus. It combines Cognitive Behavioral Therapy (CBT) and Sound Therapy, and can help to manage both the phantom sound and the psychological effects of tinnitus.
As research continues, more theories emerge, as well as possible treatments for tinnitus. We’ll explore some of these experimental/alternative treatments, and what they can mean for tinnitus relief:
Red Light Therapy
Red light therapy, or low-level light therapy (LLLT) uses electromagnetic waves to address symptoms of tinnitus. In a process known as photobiomodulation, the red/near-infrared light energy uses a precise laser to target specific areas of the body, such as the auditory cortex.
In one study, using animal models, researchers were able to activate the potassium ion KCNQ2 channels. These regulate neuron excitability in the auditory brain, and have the potential to reduce tinnitus in patients with noise-induced hearing loss.
Electrical stimulation
The American Tinnitus Association already recognizes electrical stimulation as a viable treatment approach for tinnitus. Many of these treatment approaches are still in the experimental phase, while others are not yet as widely available to the tinnitus community. These include:
- Repetitive Transcranial Magnetic Stimulation (rTMS) is a non-invasive stimulation method already in use for various mental and neurological conditions such as depression, bipolar disorder, and OCD. It uses electromagnetic coils placed on the head, targeting specific brain areas, and sending pulses to the auditory cortex.
- Transcranial Direct Current Stimulation (tDCS) also uses a non-invasive approach to address tinnitus. This treatment uses a series of electrodes that send electromagnetic pulses through the skull, to the parts of the brain responsible for interpreting sound.
- Unlike rTMS and tDCS, Deep Brain Stimulation (DBS) is an invasive approach to electrical stimulation for conditions such as Parkinson’s disease, essential tremor, and dystonia. It involves surgical implanting of electrodes directly into the brain, which can then modulate the abnormal firing patterns of neurons that cause tinnitus.
- Vagus Nerve Stimulation (VNS) involves using a mild electrical current to the vagus nerve, typically through an implantable device, for the treatment of conditions such as epilepsy and depression. Researchers aren’t exactly sure why stimulating the vagus nerve has the effect of reducing tinnitus, but it has shown promise where other treatments have failed.
Bimodal stimulation
Bimodal stimulation describes using two modes of sensory stimulation at the same time. The purpose of this is to retrain the brain to respond differently to the tinnitus perception. It is also meant to reduce distress in patients, and teach them to live alongside their tinnitus symptoms.
When treating tinnitus, the auditory nervous system is stimulated at the same time as the somatosensory neural pathways. The auditory system contains all structures and processes responsible for detecting, transmitting, and interpreting sound. This includes the outer, middle, and inner ear, as well as parts of the brain. The somatosensory system involves all the nerves that allow us to perceive touch, temperature, body position, pressure, and pain. These systems intersect at the base of the spine, where auditory information is sent to the same place as information from somatosensory nerves in the face, tongue, jaw, and spinal column.
Research has found that using sound stimulation at the same time as stimulating the somatosensory nerves can influence the way they are interpreted in the brain. In other words, they can reduce the spontaneous firing of nerves, which may, in turn, reduce the tinnitus. Bimodal stimulation devices can take many forms, whether as a wristband, as Neosensory’s Duo Device, or a headset with a mouthpiece, like Neuromod’s Lenire Device.
SSRIs
SSRIs, or Selective Serotonin Reuptake Inhibitors, are designed to increase the amount of serotonin within the brain, making it a staple when treating depression. This class of drug also has other uses, such as managing symptoms of anxiety, insomnia, as well as mood swings. This is not a primary treatment for ringing in the ears, but it can be helpful for those with severe symptoms by easing the emotional distress associated with tinnitus. In many cases, this is accompanied by talk therapy, or Cognitive Behavioral Therapy (CBT) for best results.
Lidocaine Patches
While lidocaine patches aren’t a direct cure for tinnitus symptoms, they can be useful when managing its symptoms. Lidocaine patches contain lidocaine, a local anesthetic, which numbs the area where the patch is applied. This is especially useful for people with minor pains, as well as nerve pain.
Lidocaine is already considered a treatment for tinnitus caused by an arrhythmia, or irregular heartbeat, which can make the ear sensitive to changes in blood flow. Besides lifestyle changes for general well-being, lidocaine is injected directly to the inner ear, or placed in an IV. This is also a current treatment for Ménière’s disease. When used as a patch, the lidocaine can be slowly released into the body, as well as reduce any additional symptoms caused by rapid absorption of the anesthesia.
Treat Tinnitus with Help from Treble Health
Struggling with tinnitus? Treble Health offers personalized solutions for patients who deal with chronic ringing in the ears. You don’t have to face it alone. We are a community of thousands of tinnitus patients and providers who work together to find a range of solutions, even in the most complex cases.
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