Fighting iPod Deafness, Sound Pharma Focuses on Teens Cranking up the Volume

6/22/11Follow @xconomy

The iPod made tiny earbuds supercool. But the digital music revolution has created some damaging consequences, as millions of young people listen to songs for hours every day at sometimes deafening volumes.

Most of them won’t turn down the noise anytime soon, and as millions develop early forms of hearing loss, it is creating a big new opportunity for a Seattle-based biotech company, Sound Pharmaceuticals.

“I’ve talked with a lot of people who say things like, ‘I was in the elevator the other day, and I could hear that guy’s iPod playing, so I can only imagine what he’s exposing himself to,’” says Jonathan Kil, Sound Pharma’s CEO. “A lot of parents of teens are obviously concerned.”

Hearing loss is one of the most common health ailments in the U.S., and one of the last unexplored frontiers of the pharma and biotechnology industry. An estimated 30 million Americans have debilitating hearing loss and balance disorders. Scientists say the ailment comes from an accumulation of exposure to high-decibel environments—noisy factory workplaces, repeated gunfire if you’re a military veteran, old-fashioned age-related hearing loss, or, yes, excessive cranking of the iPod at any age. About one in five adolescents is now affected by hearing loss, according to a national health survey. Yet there are still no drugs specifically approved by the FDA, and scientists are still very much in the dark about what’s going wrong biologically in the ear, and how to go about treating the condition.

Sound Pharmaceuticals has been around since 2002, and has no approved drugs on the market. It has raised about $10 million in government funding, and another $10 million in investment capital to develop treatments for hearing loss, Kil says. The company spent much of the last three years trying, unsuccessfully, to recruit active military servicemen and women into a clinical trial that would test its lead compound. That trial struggled to enroll enough volunteers, partly because the military is stretched thin fighting overseas wars, and line commanders are unwilling to let their people join an eight-week clinical study, Kil says.

Jonathan Kil

So Sound Pharma has switched gears, and is focusing now on a new patient population—those 18- to 31-year-olds who are blasting their ears on a daily basis with music.

This test is still in the very early stages, so it has a long way to go before it can be proven worthy of a spot on the market. Sound Pharma has shown that it can consistently protect mice, rats, and guinea pigs from temporary and permanent hearing loss, and has published its findings, Kil says. The next step is a clinical trial, led by Colleen Le Prell at the University of Florida. Her Florida research team will recruit 80 young people who will be randomly assigned to a placebo or a low, medium, or high dose of the Sound Pharma drug two days before they are exposed to four hours of loud music—which Le Prell has shown can induce a temporary hearing loss.

Like many experimental drugs, scientists have some ideas about how the new treatment might be working, but much of its action is unknown. The new drug is … Next Page »

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  • Saumitra

    Thanks Luke – good article. It did focus on how and why Sound Pharma changed gears to focus on different , quickly gettable patient population. Would also help Sound Pharma expand their potential market !

  • http://www.xconomy.com/author/ltimmerman/ Luke Timmerman

    Here’s a comment just in from Collen Le Prell at the University of Florida, the lead investigator on this new hearing loss trial in young adults:

    “Ebselen has been very effective in pre-clinical animal models, with respect to both temporary changes in hearing immediately after noise, as well as prevention of permanent noise-induced hearing loss. In this clinical trial, we hope to show that SPI-1005 reduces the changes in hearing that can occur after use of a digital music player.”

  • http://depts.washington.edu/rubelab/ Edwin W Rubel

    I have worked in the area of hearing and hearing loss for the past 35 years, and have carefully followed the work on Ebselen and other antioxidants. I have also carefully read the work published by this group and other groups on Ebselin.

    The published papers are very difficult to understand because there are numerous important technical flaws as well as strange interpretations of the data. Furthermore, this work , like much of the other work in this field suffers from the fact that a very small number of subjects are tested, the statistical analyses are performed incorrectly. FIt is also well accepted that pharmacological analyses, responses as a function of dosages must be evaluated for a broad range of “doses” of the challenge (noise exposure in this case, and a wide range of the proposed therapeutic agent (Ebselin in this case). Such data have not been present in any of the publications.

    Finally, as a hearing scientist, it is hard for me to understand why anyone would want to take a drug to protect against Temporary threshold shifts from iPod usage. If TTS is experienced, one can merely turn don the volume, and if the Sound Pharma people are suggesting that a drug that protects from TTS will protect from permanent threshold shift, they are probably mistaken. Ear plugs will protect from both, but it is clear that the cellular pathways resulting in permanent hearing loss involve processes independent of those related to the temporary shift.

  • http://www.noisehelp.com/ Sarinne Fox

    In reply to Dr Rubel: Although it’s true that hearing damage from iPod use can be avoided by simply controlling the volume, there are other causes of hearing damage, cases for which a prophylactic drug might offer the most feasible way to avoid hearing damage. In active military service (where the company originally tried to recruit clinical trial subjects), hearing protection measures take a back seat to the vital necessity of hearing events in the environment and orders to be followed. And there is a long list of ototoxic drugs, some of which are lifesaving; if a way can be found to reduce their damaging effects, that would be a good thing.

    Even in the case of iPod use, what’s wrong with having more than one way to avoid hearing damage? Surely the more options we have for preventing hearing damage, the better.

    If this particular experimental drug turns out not be be a good solution, perhaps a different drug or other approach will be found. That’s the point of research.

    I am interested in seeing the data on the independent cellular pathways for permanent hearing loss vs temporary threshold shift. If you can point me to a link it would be much appreciated. Thanks!

  • http://depts.washington.edu/rubelab/ Edwin Rubel

    Dear Ms Fox

    You are entirely correct that there are many situations in which hearing loss due to excessive noise exposure, treatment with therapeutic drugs or exposure to environmental conditions can not be avoided, there are many high quality groups throughout the world publishing excellent research on this topic, and other experimental drugs are being developed and tested. This is an active field of research and should be supported.

    The problems here are the approach taken and the quality of the research published by this and other groups examining the effects of Ebselin. But let me repeat: this area of research is enormously important, especially when one considers that the great majority of people suffer serious hearing loss as they age, people are living longer and therefore a greater and greater percentage of our population is seriously hearing impaired.

    I have already commented on the technical difficulties of the work on Ebselen. They are sufficiently extensive and technical that I will not elaborate on the details here. More important for the lay public is “does it work and can it work to prevent hearing loss in a large number of people”. As a scientist, I would never say something CAN NOT work, but the available evidence to date suggests that it does not work, and there are good reasons. First, consider the fact that the first papers on Ebselen and hearing loss were published over a decade ago and the use of antioxidants to prevent hearing loss is several decades old. One would think that if this therapy was broadly effective, then work on Ebselen would be widespread and the therapeutic advantages would be widely developed by the pharmaceutical industry. In fact, other laboratories have not generally found robust protection by Ebselen or other antioxidants; animal research has generally shown they protect over a very small dosage range; and clinical use has not expanded. The reasons for their lack of effectiveness over a broad range are well known and relate to the mechanisms of cell death and injury. My views are not unique in the scientific community. For example, Dr. Keiko Hirose, a clinician and highly respected authority in this field, who is a professor at Washington University in St. Louis, states a similar view in a recent review and concludes, “clinical trials have been disappointing.” The fact is that most people that eat a good diet get plenty of antioxidants and my bet is that this is generally true in military diets.

    Finally, you ask for a link to a site showing that the pathways leading to temporary threshold shift (recoverable damage due to excessive exposure to loud noise like high volume iPod use) are different than those leading to permanent hearing loss. I’m sorry, but I can not provide you a single “link”. Full knowledge of these pathways is not nearly understood at this time. If it were, we’d be able to solve the problem wouldn’t we? It is clear, that the vast majority of permanent hearing loss from these causes is due to the actual death of the inner ear receptor cells, the tiny hair cells, alone or in combination with a nearby structure called the stria vascularis. Temporary threshold shifts do not involve actual death of the hair cells. Furthermore, the most prevalent views of the cellular basis of temporary threshold shifts are that in involves damage and recovery of the the tiny hair-like structures in the hair cells, or a temporary break in the connection between the hair cells and the nerve leading to the brain. However the actual death of hair cells has been shown to be independent of these events.

    I can not take the time to respond at this length to each inquiry posted at this site. But, if any reader wishes to find out more about this topic, I invite you to contact the Virginia Merrill Bloedel Hearing Research Center at the University of Washington, Seattle, WA. We will be more than happy to provide much more information.

  • http://www.soundpharma.com Jonathan Kil

    Hi Sarinne,

    Thanks for your comments. In response to Ed’s responses I must say that his comments on antioxidants are somewhat correct in that the n-acetylcysteine (NAC) clinical studies have been disappointing and may be due to the high injected animal doses required to achieve poc vs the lower oral doses used in the marine recruit studies that did not achieve significant poc. Additionally, it is unclear whether the exact mechanisms involved in the induction of temporary hearing loss are the same as those responsible for permanent hearing loss. What is very clear is that they both involve sensori-neural structures within the cochlea and that the human cochlea shows injury or loss of hair cells, neuronal cells, and strial cells. Ebselen is a synthetic molecule that has some antioxidant activities but works more potently as a Gpx mimic and inducer and has significant anti-inflammatory and anti-apoptotic or anti-cell death properties. It has been shown to be effective with low oral and injected dosing in several animal models of noise and chemotherapy induced hearing loss, both at temporary and permanent time points. The ability of ebselen to protect auditory hair cells, auditory neurons and the stria vascualris in the cochlea at TTS and PTS, and its demonstrated oral safety and bioavailability, makes it unique in the literature. This work has been independently published by several groups in the US, Japan, Korea, Germany, and France. I am the inventor on several patents including some that involve ebselen and hearing loss as well as the cofounder and ceo of Sound Pharma which is developing this molecule in three Ph-II human clinical trials. Unfortunately, I think Ed’s comments are driven more by personal bias than by scientific objectivety at least when it comes to ebselen.

  • http://www.noisehelp.com/ Sarinne Fox

    Thank you, Dr Rubel and Dr Kil, for your thoughtful and informative (and prompt!) responses. I am excited and encouraged by the research activity in this area and certainly want to see the most promising avenues encouraged and supported. As we know, even “negative” findings can be tremendously useful in guiding future efforts.

    I hope that the competing views can be a healthy springboard for further study, discussion, and creative work, not only to investigate new approaches but also to do the important development work needed to make safe and effective products available to the market.

    Dr Kil, the technological overview on your company’s website is very helpful; thanks.
    http://www.soundpharmaceuticals.com/technology.html
    I’ll be watching this work with interest.

  • http://depts.washington.edu/rubelab/ Edwin W Rubel

    Dear Readers

    Dr Kil is correct that ebselen has many other targets than just free radicals. In fact we do not know all the targets, but some can be effective in reducing toxicity under some circumstances. That is not the issue here. The issues are: 1) this drug and others with similar properties protects hair cells from degeneration over a very narrow dose range, one that is not robust enough to be useful for clinical use; 2) to date the studies done by this group on protection from permanent noise damage by ebselin are enormously technically flawed in several respects, such that the results can not be interpreted with any confidence.

    Dr Kll goes on to list his credentials: These include being “the inventor” of several patents, and being the ceo of Sound Pharma. I believe he is one of several inventors on several US patent APPLICATIONS. Indeed he is the co-founder and ceo of sound Pharma. He fails to mention that he is an MD who has never had even an internship, and has never practiced medicine. He does not have a PhD and has minimal training in science. The little work he has done in a hearing science laboratory did not include actually testing hearing in animals. Dr Kil does appear to be a practiced entrepreneur.

    Finally, he makes the outlandish claim that my opinions are “driven by personal bias “when it comes to ebselen”. While I have published over 300 articles on various aspects of hearing science, hold an endowed chair at the University or Washington, and was the founding Director of the Virginia Merrill Bloedel Research Center at the University of Washington, I have never worked with ebselen or any of its close relatives. I have no reason to have a “personal bias” on this matter. My only objective is to use my long experience in this field to provide a truthful and valid perspective to the public, particularly those members of our community interested in hearing loss and its remediation.

  • http://www.jprdirect.com peter garcia

    Im going to have to agree that the only solution is to just turn the volume down. I know it’s not as easy as it seems.Maybe a obvious warning label to remind them will also help.