Frequently asked questions

It’s difficult to know if your use of earbuds or headphones is damaging your hearing. Consumer tech for sound level monitoring is just starting to appear on phones, which helps if you happen to be using earbuds or headphones calibrated with a phone. Otherwise, it’s virtually impossible to know if the combination of listening time and volume are within safe limits. 

Consider using Soundbites if you’re concerned about avoiding potential hearing injury from any personal listening devices used for long periods or at loud volumes, including earbuds, headphones, or even hearing aids. But please think of Soundbites as preventive care insurance, and not as a free pass to take risks by turning up the volume.

Noise cancellation technology works well to reduce the loudness of noise entering the ear, making it easier for the brain to separate wanted signals from unwanted ones, which reduces strain on the auditory cortex. However, you’re right to be concerned. World noise is a major contributor to hearing loss, and the problem is increasing rapidly. Noise cancellation technologies can be very effective at reducing or blocking damaging noise levels, but it’s impractical to keep your ears plugged all the time with any kind of noise protection device. We encourage using hearing protection devices in addition to Soundbites because Soundbites works when not you’re not wearing hearing protection, and it provides an extra cushion of safety when you are. Soundbites is not intended to replace hearing protection devices, nor is it intended as a free pass to take risks with your hearing.

Unfortunately, it is increasingly normal to suffer hearing loss earlier in life today. So-called age-related hearing loss (ARHL) and noise-induced hearing loss, or NIHL, are biologically related, and it’s often difficult to tease the two apart. The evidence is clear: listening to loud music clearly contributes to NIHL, and increases the risk that ARHL will start at an earlier age. 

But listening to loud music is not the only cause of NIHL. A majority of the world’s population now lives in cities, and cities are noisy, adding to the noise burden, so hearing loss is happening to many more people earlier in life. The U.S. is 80% urban, and it’s expected that 70 percent of the estimated world population of 10 billion will be urban by 2050. If trends continue without interventions like Soundbites, it's estimated that 25% of the world’s population will be hearing impaired, and 10%, or 1 billion people, will be functionally deaf within the next three decades.

That’s likely, according to numerous anecdotal case reports and independent clinical assessments, but there is no way to know in advance. Hearing function is affected by a wide variety of factors including your age, genetics, lifestyle, life quality, and nutrition. With certainty, we can say that at any age, Soundbites helps your hearing cells work the way they’re supposed to work, free of oxidative stress that compromises normal auditory function and damages hearing. 

Independent clinical evidence indicates that improvement in hearing can be measured objectively by an audiologist within three months of taking Soundbites daily. You may perceive differences that accompany reduction of oxidative stress in a shorter time if your ears are under a high degree of oxidative stress, but we cannot predict that you will perceive any differences in your hearing or tinnitus symptoms, or improvement in your hearing sensitivity; there are too many variables. 

Noise exposure is the most common cause of tinnitus. Tinnitus often starts with exposure to high intensity noise. Common examples are loud music for a few hours at a live concert, or in your earbuds all day. 

Hearing loss from any cause is highly connected to tinnitus. Tinnitus is brain noise. The root cause is biologic injury or death of inner ear hearing nerve cells resulting in cognitive dysfunction within the brain’s auditory cortex. 

Anyone can get tinnitus at any age.

You’re hardly alone if you have tinnitus. The US Centers for Disease Control and Prevention (CDC) estimates that about a third of the US population, or about 105 million people, suffer from tinnitus.

The CDC also estimates that 70% and 85% of people with hearing loss have tinnitus. Hearing loss often increases with age, so does the prevalence of tinnitus. But hearing loss data is far from perfect because historically, hearing loss has been viewed as an inevitable fact of aging, so collecting hearing data hasn’t been considered a health care priority. Consequently, we can’t rely on hearing loss data to give us an accurate picture of tinnitus, either.

The scientific evidence clearly indicates that the best way to reduce the risk of tinnitus is to prevent the hearing loss that often causes it. So although our roots are in biomedical research, which typically focuses on developing drugs for disease treatment, our focus is preventive care.

Soundbites is specifically designed to preserve hearing by preventing inner ear injury, especially from noise. Soundbites works by blocking the biochemical triggers that damage inner ear nerves and initiate tinnitus. We know of no other safe product of medical research designed to do what Soundbites does.

Coping with tinnitus symptoms is a separate issue. There are no prescription pharmaceuticals for preventing tinnitus, and no drugs for treating its symptoms, but doctors can prescribe anti-anxiety drugs, antidepressants, or sleeping aids that can help manage the psychological impacts of  tinnitus.

It turns out Soundbites can help manage tinnitus symptoms too, but in a different way. By blocking the biochemical triggers that damage hearing, Soundbites helps maintain or even improve inner ear health even when inner ear function has been previously compromised. For those with tinnitus, the way Soundbites works to preserve hearing also results in less intrusive levels of phantom sounds – the brain noise generated by the auditory cortex, called tinnitus.

Yes. Age-related hearing loss, called ARHL, and noise-induced hearing loss, called NIHL, are the two most common types of sensorineural hearing loss (SNHL), which is hearing loss caused by the death of inner ear nerve cells. Noise is such a dominant form of SNHL that we just call it hearing loss. 

Conventional wisdom is that age-related hearing loss happens to older people, but that is no longer accurate. Age-related hearing loss is rising quickly among children and young adults,  mainly because of more routine and frequent exposure to intense levels of sound and noise.

The root cause of NIHL and ARHL is oxidative stress and restricted inner ear blood flow caused by excess inner ear free radicals. Hearing cells tend to produce additional free radicals as they age, moreso when they are damaged, and noise is the dominant source of that damage. NIHL accelerates ARHL, and the root cause of NIHL and ARHL is the same. 

ARHL now frequently starts in adolescence. According to the US Centers for Disease Control and Prevention (CDC), an estimated 12.5% of children and adolescents aged 6–19 years (approximately 5.2 million) have already suffered permanent damage to their hearing from excessive exposure to noise. So to describe the reality accurately, it may be appropriate to combine NIHL with ARHl into noise accelerated hearing loss, or NAHL.

No prescription drugs are available for preventing hearing loss. Given what we know about the biology of its root cause, a hearing preservation vaccine is extremely unlikely. Drug development is focused instead on hearing regeneration. Several pharmaceutical candidates are in development, but none are close to being approved.

Yes. Soundbites helps maintain the normal auditory function of hearing cells, regardless of how sound gets to your inner ear, regardless of  the level of your hearing loss. Independent clinical evidence indicates that Soundbites can improve hearing sensitivity within three months of daily use. If you rely on hearing aids, the amplification level of your hearing aids may seem to increase, which indicates improvement in hearing sensitivity. If you are under the care of an audiologist, you may wish to compare the data from your audiograms and distortion product otoacoustic emissions (DPOAE) tests from before and after taking Soundbites.

Independent evidence suggests it’s likely to notice changes in hearing sensitivity within three months of taking Soundbites daily, but keep in mind that hearing function is affected by a wide variety of factors including your age, genetics, lifestyle and life quality like nutrition, so individual predictions are not possible. But whether or not you notice, you can be certain that Soundbites is doing what we say it does,  helping your hearing cells work the way they’re supposed to work, free of oxidative stress that compromises normal auditory function and damages hearing. 

Soundbites starts working within thirty minutes, so you may notice a difference quickly if your ears are under a high level of oxidative stress and able to recover quickly. For example, one customer who lives in a quiet, remote location takes Soundbites before using her riding mower, because she used to experience muffled hearing from the noise even though she wore earmuffs, and she notices that doesn’t happen when she uses Soundbites. 

DPOAE tests performed by an audiologist confirm objective improvements in hearing sensitivity among patients taking Soundbites, but Soundbites cannot claim you will perceive any differences in your hearing or tinnitus symptoms, or improvement in your hearing sensitivity.

Tinnitus is a neurological disorder – incurable brain noise. The perceived sounds are generated in the auditory cortex, not in the inner ear. Although some who suffer tinnitus have normal hearing, the scientific consensus is that hearing loss is the main contributor to tinnitus.

Reducing spontaneous noise generation in the central auditory cortex in the brain is the hypothesis driving electromagnetic stimulation therapies including repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS). These therapies aim to reduce brain cell activity by delivering tiny amounts of electricity to the skin. There is no convincing evidence that this works.

Another approach to reducing noise generation in the brain is to use sound therapies to mask the noise of tinnitus, typically by using wearable or external devices that distract overactive brain cells. Masker therapies are safe, typically require long-term time commitments and are somewhat effective.

Our hypothesis is that spontaneous noise generation in the central system can be reduced by decreasing the level of over-excitation of afferent neurons in the peripheral system (the inner ear). We extend that hypothesis to include stereocilia cells (so-called hair cells, the cells that transform soundwaves into electrical signals).

Our approach to accomplishing the reduction in central auditory cortex sound-generating activity is to administer the Soundbites micronutrient formula orally. The formula provides the mitochondria of afferent nerve cells and stereocilia cells with the precise micronutrient supplementation they require to continue functioning normally, especially when these cells would otherwise be under hypoxia-generated stress that causes irreversible, lifelong downstream auditory problems including, but not limited to tinnitus.

Many hearing aid and cochlear implant studies appear to support the view that restoring signal output from the cochlea to the brain should also abolish tinnitus. 

The current view, therefore, is that tinnitus is a neurological disorder encompassing the peripheral and central auditory system, and that maintaining normal function in the auditory system is the route to avoiding tinnitus. Those who suffer tinnitus as a result of auditory system disorder tend to experience relief from tinnitus symptoms, because Soundbites ameliorates auditory function.

No. Pharmaceutical companies discover, patent, and test novel drugs and vaccines for management and treatment of various diseases.

Soundbites PBC makes only one product, a novel formulation of micronutrients discovered, patented, and tested to preserve hearing. 

All pharmaceutical products must be approved by the FDA before they can be manufactured for sale. Because all drugs have side effects, which must be monitored, approved drugs and vaccines can only be prescribed by physicians or offered by public health authorities, as in the recent case of covid vaccines.

In contrast, the active ingredients in Soundbites are classified by the FDA as “Generally Regarded as Safe” (GRAS). Soundbites does not have side effects requiring physician monitoring, and is safe for all ages.

There are no drugs specifically approved for hearing preservation, but because inflammation causes most inner ear disorders, doctors often prescribe corticosteroids, a class of drug that reduces inflammation.

No. Soundbites is a nutraceutical – a safe nutritional medicine. The inherent safety of Soundbites and lack of side effects allows it to be classified by the FDA as a dietary supplement – a food, not a pharmaceutical.

Soundbites is a product of biomedical R&D funded by government grants from the US National Institutes of Health and the European Commission spanning three decades.

It’s likely, but caution is warranted. Perceived changes may take time to notice, but precise forecasts are not possible. 

Hearing function is affected by a wide variety of factors including your age, genetics, lifestyle and life quality like nutrition. At any age, Soundbites helps hearing cells work the way they’re supposed to work, free of oxidative stress that can compromise normal auditory function, disrupt mitochondrial DNA, and damage hearing. 

An ongoing independent clinical study of Soundbites has been testing participants every three months since late 2019. Objective changes are typically detected within that time. 

You may perceive differences that accompany reduction of oxidative stress in a shorter time if your ears are under a high degree of oxidative stress, but we cannot claim you will perceive any differences in your hearing or tinnitus symptoms, or improvement in your hearing sensitivity.

We suggest following the clinical study protocol. Take Soundbites daily for three months. If you perceive changes during that time, you’ll know it’s working. If not, stop taking Soundbites and see if you notice regression, because differences, if any, will likely be gradual, and you may not notice them until after you stop.

Soundbites can be an important complement to hearing aids and cochlear implants, which are fundamentally devices that amplify sound, because Soundbites protects and preserves hearing cells, and maintains normal auditory function, especially when sound is above a safe level. 

Your hearing doctor likely administers subjective and objective hearing tests in order to accurately  program your hearing aid device to compensate for your hearing loss if you rely on hearing assistance devices.

If you are using Soundbites, we suggest informing your doctor or audiologist. Hearing test data will provide evidence of measurable effects of Soundbites over time.

To be clear, there are no approved drugs to regenerate hearing, and Soundbites is not a drug. 

However, by maintaining normal hearing function, Soundbites can improve hearing sensitivity over time. That improvement can be perceived and measured objectively by audiologists with the distortion product otoacoustic emissions test (DPOAE). 

Perception may include improved hearing acuity – sharpness or keenness – which, for example, makes it easier to separate speech from background ‘babble’. If you wear hearing aids, you may notice that they sound louder, maybe even too loud.

In some cases, clinical data indicates improvement in middle frequencies (the speech frequencies) of up to 30dB or more within three months.

Yes. An attack of sudden hearing loss is called sudden sensorineural hearing loss, or SSNHL. Typically, the cause of an SSNHL attack is considered idiopathic, meaning it arises spontaneously without a known cause. However, if the cause of the SSNHL attack  is biological inner ear trauma, Soundbites can and has aided recovery. We urge you to start taking Soundbites immediately, and contact your medical provider.

As a general rule,the micronutrients in Soundbites don’t interfere with prescription drugs. 

Specifically, with respect to blood pressure and heartbeat medications, it’s all good news. Fast heartbeat medications are beta blockers. Soundbites is safe to take with beta blockers. 

With respect to blood pressure medications, a comprehensive review of human studies of Magnesium (Mg) therapy for hypertension (HT) in demonstrated that supplemental Mg may enhance the blood-pressure (BP) lowering effect of anti-hypertensive medications.

This means the Magnesium in Soundbites may potentiate the effectiveness (increase the power or effect) of some anti-hypertensive medications. Consultation with your prescriber is recommended.

First, flavonoids are often marketed as antioxidants, but research by the European Food Safety Authority (EFSA) and others suggests that flavonoids have negligible (5%) antioxidant absorption.

Second, one of the most-well known flavonoid products marketed for tinnitus dates from 1961. It contains flavonoid, principally; and also vitamin C; B-complex vitamins 1, 3, 6 and 12; choline bitartrate and inositol. Aside from vitamin C, we can find no demonstrated evidence that any of the other ingredients are beneficial for maintaining the structure and normal function of inner ear nerve cells.

Soundbites is medically validated and clinically proven to protect and preserve hearing by eliminating excess inner ear free radicals, the root cause of auditory system inflammation. Since tinnitus is often a consequence of neuroinflammation and hearing loss. reducing auditory system inflammation helps relieve tinnitus symptoms.

Yes. The ingredients in Soundbites are classified by the FDA as Generally Regarded as Safe (GRAS). 

There is no indication that Soundbites interacts with pharmaceuticals, and there are no side effects from taking Soundbites.

The safety of micronutrient supplements – vitamins and minerals – has been researched since the first vitamins were discovered about 100 years ago. Soundbites softgel capsules are suitable for ages 9 and up.

The amount of each micronutrient in Soundbites is higher than the RDI (recommended daily intake) but lower than the UL (upper limit).

Cigarette smokers and those with lung cancer are encouraged to consult a doctor before taking supplemental vitamin A. 

Children under 9 years of age require a smaller dose than contained in one Soundbites softgel capsule for adults.

A low-dose form of Soundbites for children has been developed. Availability in 2022 is expected. 

Please contact hello@soundbites.com for a dosing chart and instructions for administering Soundbites to young children, especially those with clinical indications of free radical-induced hearing impairment including GJB2/connexin 26 genetic mutation; aminoglycoside ototoxicity; and congenital cytomegalovirus (cCMV).

No, Soundbites is not a drug. Soundbites is a nutritional medicine marketed in compliance with FDA dietary supplement (DSHEA) law.

Soundbites is available without a prescription because it is safe. Side effect monitoring by a physician is not required.

Yes, quite safe. Beta carotene is provitamin A, which the body converts into vitamin A as needed, avoiding the risk of vitamin A toxicity. That’s the reason there’s no need to set an upper limit on daily intake of beta carotene.. 

Studies of beta carotene have used daily doses up to 180 mg (that’s 180,000 mcg, or 20 times the amount in Soundbites) with no adverse effects. Further, there is no difference between naturally occurring or chemically synthesized beta carotene.

Beta carotene is particularly useful for neutralizing inner ear free radicals, the oxidative molecules released in the metabolic process which, in excess, cause neuroinflammation that damage mitochondrial DNA, resulting in cell death. So beta carotene helps keep hearing cells alive.

There is no cure and no prescription pharmaceuticals for treating tinnitus, so tinnitus therapies are focused on managing symptoms. Doctors prescribe anti-anxiety drugs, antidepressants or steroids to help cope  with the psychological impacts. 

Soundbites was developed to preserve hearing, not to treat tinnitus. However, because hearing loss is related to tinnitus, preserving hearing also helps avoid temporary tinnitus and relieve tinnitus symptoms. 

Soundbites may not work for everyone with tinnitus.  Results vary, and changes typically happen gradually.  Some customers who use Soundbites to manage tinnitus symptoms perceive relief after several months, others within a month, some even sooner, and some not at all. Some report being unaware that Soundbites is helping until after they stop using it, and notice that their tinnitus symptoms get worse.

It depends on your situation. Soundbites starts working within 30 minutes after taking it. So for example, taking Soundbites before you’re planning to attend a live concert or arena sporting event is a good way to get extra hearing protection quickly, and protect your ears from traumatic injury and its symptoms, ringing in your ears and muffled hearing. 

The time it takes to damage hearing changes quickly with loudness and time. Sound levels above 80 or 85 dB become unsafe, and time your ears can tolerate increasing sound levels drops fast. Hearing damage starts within two minutes when sound reaches 110 or 115 dB.

Research indicates the biological damage resulting from damaging levels of sound from any environmental source typically happens over  several days. So if Soundbites is ‘on board’ ahead of time, you may not experience temporary tinnitus or muffled hearing. Or the symptoms may be milder and resolve faster. Continuing to take Soundbites for several days afterward helps recovery. 

What we’ve covered so far is temporary threshold shift (TTS) or temporary hearing loss. TTS can cause tinnitus that can last from a few hours up to six months, called temporary tinnitus. 

Tinnitus that lasts longer than six months is called permanent tinnitus, which is incurable. Symptom management is the best care available, and Soundbites has been demonstrated to help relieve symptoms of permanent tinnitus. 

For some with permanent tinnitus, Soundbites works within a few days or weeks. Others take Soundbites for 6 weeks or longer before they perceive relief. 

Those who take Soundbites to relieve permanent  tinnitus symptoms typically report slow improvement in symptoms over time, and fast resurgence of symptoms if they stop taking Soundbites. Some with permanent tinnitus perceive no relief within three months, or episodic relief.

There is much more to learn about tinnitus, and Soundbites customers are teaching us and others about its varied forms. Here’s an example.

A Soundbites customer has been suffering with metallosis-induced tinnitus for about a decade. The tinnitus was caused by free-floating Chromium (Cr) and Cobalt (Co) cations from a failed joint replacement. Thousands of others also suffer as she does. She reports that Soundbites really helps her. “The ringing is softer and easier to ignore,” she says.

A cation ( "cat eye on") is a positively charged ion. Metallosis is the accumulation of cations from metal debris in the soft tissues of the body. Our review of the research indicates that Co and Cr metallosis toxicity is due at least in part to the ability of Co to stabilize hypoxia inducible factor (HIF) and mimic hypoxia, a condition where tissues and cells are deprived of adequate oxygen supply. Hypoxia is a root cause of sensorineural hearing loss (SNHL), and SNHL is highly correlated with tinnitus. Co and especially Cr are divalent cations, as is Magnesium (Mg), so it could be that Mg is displacing the Cr or Co in hair cells, or blocking their action in some other way. Research in rats shows damage to both hair cells and the spiral ganglion cochlear nerve cells, especially from Co.

It is perfectly logical to think that Soundbites would be helpful in mitigating divalent cation poisoning, but that can only be proved in real world evidence studies of people who suffer this troubling variant of tinnitus. So far we have one case report.

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