NEW Treatments RESTORE LOST HEARING

Over 20 treatments for hearing loss and tinnitus are currently being tested in clinical trials.

Treatments that regenerate hearing

Last month, Frequency Therapeutics announced that its regenerative therapy for hearing loss had progressed to Phase I/II of clinical trials. Frequency Therapeutics is a US-based company developing a drug called FX-322. This drug has the potential to repair the damaged inner ear by regenerating the Inner Ear hair cells and restoring hearing.

Hair cells transform sound into electric signals that the brain understands and are frequently damaged or lost in sensorineural hearing loss. At the end of 2017, Frequency “Therapeutics” finished an initial test in a small group of people showing that the drug was safe. They are now progressing to test how well the drug restores hearing, and how safe it is, in a larger number of people.

The REGAIN consortium, an international consortium supported by EU funding is also testing a drug that works as a chemical ‘switch’ to produce new hair cells from other cells in the inner ear, called ‘supporting cells’. Their Phase I clinical trial is taking place in the UK, at the UCL Ear Institute and Royal National Throat Nose and Ear Hospital. Read details about this study.

Novartis, one of the biggest global pharmaceutical companies, is also undergoing a Phase I/II trial with a gene therapy, CGF166, which aims to activate supporting cells to generate new hair cells and restore hearing.

If these treatments prove to be effective, they will have the potential to be used in several different types of sensorineural hearing loss.

Treatments that prevent hearing loss

Sensorion, a French company that is developing several treatments for inner ear disorders, vertigo and tinnitus, has finished a Phase I trial for sudden sensorineural hearing loss and will soon progress to a Phase II clinical trial.

Sudden sensorineural hearing loss, also known as sudden deafness, is characterized by a rapid loss of hearing that can happen at once or over a period of several days. Most of the time the cause is unknown, but infectious diseases, head injury, or other disorders can trigger this condition.

Sensorion’s drug will be tested in hundreds of people in different regions of the world. Their drug (SENS-401) aims to stop the progression of hearing loss by preventing damage to the Inner Ear hair cells and nerve cells that connect the ear to the brain.

An increasing number of treatments that have not yet reached clinical trials are also under development. Both private and public investors have been increasing their financial support to these treatments, which will help to make them available to patients faster.

For instance, Decibel Therapeutics, a US-based company dedicated to the discovery and development of medicines for hearing loss, raised $55 million in June 2018 from private investors to develop treatments for hearing disorders.

 Otomagnetics is a US-based company that is developing a more efficient way of delivering treatments to the hard-to-reach inner ear by using a magnetic injection system. At the end of last year, Otomagnetics was awarded a $2.3 million grant from the National Institutes of Health.

Prior to this, in 2013, we awarded Otomagnetics a Translational Research Grant of £300,000. Our funding was crucial in enabling the company to carry out initial testing of their magnetic injection system. This was necessary for them to obtain the larger follow-on funding, which will be essential to progress their system to be used in people.

The concerted effort of researchers, industry, funding bodies like Action on Hearing Loss, and private investors has been crucial for increasing the number of treatments currently being tested for hearing loss and tinnitus. The future looks promising and we are all eagerly waiting to see these treatments pass the different phases of clinical trials and bring everyone the opportunity to protect and restore their hearing.

The clinical trial stage comes after these medicines are shown to protect or restore hearing in animal models. Being in clinical trials means that they are now being tested in people to assess how effective and safe they are. All treatments have to be tested in three phases of clinical trials before being approved and made available to everyone.

  • Phase I makes sure that the medicine is safe to be used in people.
  • Phase II tests if the medicine is effective, meaning that it prevents or treats the condition, and establishes the dose at which it needs to be given to people to be effective.
  • Phase III is usually a trial that involves a larger number of people, confirms the effectiveness and safety of the medicine, identifies any side effects, and compares its benefits in relation to its risks.

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New information for age-related hearing loss

A new study published in the American Journal of Clinical Nutrition found a strong connection between eating two or more servings of some fish per week and a decreased risk of hearing loss.

Researchers analyzed almost two decades’ of data from 65,215 women enrolled in the Nurses’ Health Study II. In the study, women self-reported on their diet, as well as about hearing loss, among many other things.

In this prospective study among 65,215 US women, we observed a lower risk of hearing loss among women who consumed 2 or more servings of fish per week. Consumption of any specific type of fish (tuna, dark-meat fish, light-meat fish, or shellfish) tended to be associated with lower risk. In addition, higher intake of long-chain omega-3 (fatty acids) PUFAs was inversely associated with risk. These findings suggest that diet may be important in the pathogenesis of preventing or reducing hearing loss.

Evidence suggests regular fish consumption (1–2 servings per week) may protect against several diseases, such as coronary artery disease (40), sudden cardiac death (41), ischemic stroke (21), atrial fibrillation (42), cognitive decline (43), and dementia (44). The proposed benefits of fish intake may be attributable in large part to the long-chain omega-3 fatty acids that fish provide. Finfish and shellfish are the chief dietary sources of the major long-chain omega-3 PUFAs, EPA (20:5n−3) and DHA (22:6n−3), often referred to as “marine” fatty acids. Intake is particularly essential for DHA, because it cannot be synthesized appreciably after infancy (45). DHA appears to be important during auditory neuro-development, and higher dietary intake of DHA in breast milk or supplemented formula during early infancy is associated with accelerated maturation of auditory brainstem response latencies (4647).

To read  the entire study click here  http://ajcn.nutrition.org/content/100/5/1371.full

Hormone deficiency could be destroying your hearing,

Dennis Trune, Ph.D., of Oregon Health Sciences University, pioneered the research showing that the naturally occurring adrenal steroid hormone aldosterone can often reverse hearing loss in animals.

Bio-identical aldosterone: what is it?

A bio-identical version of the hormone aldosterone is increasing in popularity as an experimental treatment for age-related hearing loss and some other forms of hearing loss. In addition to regulating kidney function, aldosterone plays a role in controlling levels of two crucial signaling chemicals in the nervous system: potassium and sodium. The proportion of sodium and potassium is particularly important in the inner ear, where potassium-rich fluid plays a central role in converting sounds into signals that the nervous system recognizes.

Research on aldosterone for hearing loss

In 2005, a team from the International Center for Hearing and Speech Research, a leading group from the University of Rochester, found that the more aldosterone older people have in their bloodstreams, the better their hearing.[1] They discovered that people with severe hearing loss have an average of half as much aldosterone in their bloodstreams as those with normal hearing. The researchers also linked lower aldosterone levels with difficulty discriminating sounds against a noisy background, another hallmark of age-related hearing loss. The authors of the landmark study concluded “that aldosterone hormone may have a protective effect on hearing in old age.”

Around the same time, another research team from Oregon Health Sciences University was investigating the role of aldosterone in other forms of hearing loss caused by autoimmune processes. They confirmed that boosting levels of aldosterone effectively restores hearing in mice with autoimmune hearing loss.[2,3]

Current use of aldosterone for hearing loss

Aldosterone is currently available in both natural (bio-identical) and synthetic forms. Unfortunately, despite the encouraging preliminary research findings, the safety and efficacy of aldosterone for hearing loss have not been evaluated in humans.[4] That hasn’t stopped some natural and integrative physicians from prescribing it, however, and reporting promising results. For instance, Dr. Jonathan Wright, MD, a leading physician in bioidentical hormone replacement therapy, is currently prescribing low doses of bioidentical aldosterone to patients with hearing loss who also have low baseline levels of aldosterone in their blood or urine.

Based on Dr. Trune’s work, I’ve had aldosterone levels tested in many individuals with hearing loss (most of them “older”), and a significant number turned out to have low or “low normal” measurements. But after taking bio-identical aldosterone in “physiologic” quantities—amounts that would normally be present in adult human bodies—more than half of these individuals have regained a significant proportion of their “lost” hearing.

I’ve been surprised by two aspects of bio-identical aldosterone treatment for hearing loss. First, when it works, it works relatively rapidly, restoring a significant degree of hearing within the first two months. In fact, a few of the people I’ve worked with have literally heard improvement within just two to three weeks.

The other thing that surprised me about aldosterone therapy is that it’s capable of restoring a significant degree of hearing even years after the hearing loss initially occurred. So far, the longest interval I’ve witnessed was in an 87-year-old man who’d lost his hearing 13 years prior to regaining a significant degree of it using aldosterone.

None of the people I’ve worked with have had any adverse effects from aldosterone therapy, likely because the use of bio-identical, physiologic-dose aldosterone restores levels to those that would be found in the body anyway.

I’ve focused this treatment on individuals with hearing loss and low or low-normal aldosterone levels,

hormone deficiency that could be destroying your hearing Dennis Trune, Ph.D., of Oregon Health Sciences University, pioneered the research showing that the naturally occurring adrenal steroid hormone aldosterone can often reverse hearing loss in animals.

Based on Dr. Trune’s work, I (Dr. Wright, MD) have had aldosterone levels tested in many individuals with hearing loss (most of them “older”), and a significant number turned out to have low or “low normal” measurements. But after taking bio-identical aldosterone in “physiologic” quantities—amounts that would normally be present in adult human bodies—more than half of these individuals have regained a significant proportion of their “lost” hearing.

I’ve been surprised by two aspects of bio-identical aldosterone treatment for hearing loss. First, when it works, it works relatively rapidly, restoring a significant degree of hearing within the first two months. In fact, a few of the people I’ve worked with have literally heard improvement within just two to three weeks.

The other thing that surprised me about aldosterone therapy is that it’s capable of restoring a significant degree of hearing even years after the hearing loss initially occurred. So far, the longest interval I’ve witnessed was in an 87-year-old man who’d lost his hearing 13 years prior to regaining a significant degree of it using aldosterone.

None of the people I’ve worked with have had any adverse effects from aldosterone therapy, likely because the use of bio-identical, physiologic-dose aldosterone restores levels to those that would be found in the body anyway.

I’ve focused this treatment on individuals with hearing loss and low or low-normal aldosterone levels,

Aldosterone’s benefits might not end with “autoimmune” hearing loss-it also gives
hope to those with age-related hearing loss.

Until recently, the available evidence
(research and clinical use) had shown that prednisone (and the very closely related
prednisolone)  could usually reverse autoimmune hearing loss, but it had never been
used in humans for age-related hearing loss (technically known as presbycusis).
But last November, researchers reported an association between low blood levels of
aldosterone and hearing loss in older individuals. Simply put, the more aldosterone in
the bloodstream, the better the hearing.9 In the study, 47 healthy men and women
between 58 and 84 years old were given several types of hearing tests in addition to
having their blood levels of aldosterone measured. Individuals with severe hearing loss
had approximately half as much aldosterone in their bloodstreams as those with normal
hearing, which is a highly significant difference. The researchers concluded that
“aldosterone hormone may have a protective effect on hearing in old age.”
One of the researchers said, “The inner ear is especially sensitive to any disruption in
potassium levels…We know that potassium levels in the inner ear seem to decrease as
we age and that these falling potassium levels play a role in age-related hearing loss,
and we also know that blood levels of aldosterone generally decrease with age.
“We found a direct link between blood levels of aldosterone and the ability of people to
hear normally as they age. Depressed hormone levels may hurt hearing both in the
inner ear and the part of the brain used for hearing.”10 That’s a very strong statement
and one that for the first time offers real hope for people suffering from age-related
hearing loss.
But the researcher concluded by saying, “More research is needed… to understand whether aldosterone is a cause of the failed hearing, or whether it’s symptomatic.

Before we understand the issue more fully, people should not worry about their aldosterone levels or look to boost the amount in their bloodstream.”
I can’t disagree more with this point of view. While it’s absolutely true that more research is always needed until a scientific point is proven beyond doubt, it’s also true that hundreds of thousands-if not millions-of us will lose part or all of our hearing while we wait for those definite conclusions.
Of course, it’s possible that the situation could be more complicated than “just” aldosterone regulation of potassium and sodium levels. The problem can sometimes occur when potassium channels in the inner ear malfunction. In other recent research,
mice were genetically altered to have malfunctioning potassium channels in their inner ears, and this led to hearing loss. It’s possible that some mice or humans are predisposed to age-related hearing loss because their potassium channels don’t work properly. In that case, they’d need extra aldosterone and potassium to compensate for the problem.
So, yes, additional research is needed. But whether research finds the problem is fairly simple-low aldosterone causes low hearing-or is more complicated-malfunctioning potassium channels require more help from aldosterone and potassium-the net effect is the same: It’s a potential solution for age-related hearing loss.
It is, of course, also possible that even though all the research I’ve noted points in these directions, it may not work when applied in practice. It’s happened more than once with other promising research findings. But since aldosterone is a safe, natural substance, Ithink it’s worth a try.

Dr. Wright, MD
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Tahoma Clinic physicians are currently treating hearing loss. Contact the location
closest to you for more information. http://www.TahomaClinic.com

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