Ann Arbor, Mich. (PRWEB) June 26, 2012
Soundbites, the breakthrough hearing preservation supplement developed in response to scientific discoveries at the University of Michigan Medical School, announced its clinical and real-world epidemiological studies last week at the 47th Audio Engineering Society Conference on Music Induced Hearing Disorders in Chicago.
A persistent and growing health risk in today’s world – from portable listening devices to military combat operations, from factory floors to concert halls – hearing loss is a fast-trending public health concern.
Soundbites applies the important scientific discovery that noise trauma releases excessive levels of free radicals into the delicate and complex cellular structures of the inner ear, creating cell trauma and ultimately triggering cell death that causes permanent hearing loss. Soundbites is a new, biological approach to hearing conservation – a high potency formulation of four powerful antioxidant micronutrients, precisely formulated to act in different compartments of inner ear cells to eliminate oxidative stress and improve inner ear blood flow. Soundbites is manufactured to pharmaceutical standards, and includes amounts well above standard multivitamins.
Soundbites is patented by the University of Michigan. Hearing Health Science, Inc. is the exclusive worldwide licensee. As a new therapeutic, Soundbites has already passed extensive first-level pre-clinical pilot tests. Clinical trials are ongoing in the U.S and Europe funded by the U.S. National Institutes of Health and the European Commission Public Health Research Programme.
The U.S. National Institutes of Health is supporting a University of Florida trial to assess efficacy of these four key nutrients to reduce or prevent temporary hearing loss from noise trauma. The European Commission Public Health Research Programme is supporting clinical studies at the University of Hannover, Germany to assess the ability of Soundbites to protect delicate inner ear structures and preserve natural hearing in patients receiving cochlear implants.
The EC grant also supports laboratory studies of Soundbites to improve understanding of inner ear cell death mechanisms underlying age-related hearing loss, and test the efficacy of Soundbites to reduce this risk. Laboratory studies have also demonstrated Soundbites efficacy to reduce ototoxicity associated with some pharmaceuticals, potentially reducing the risk of permanent hearing loss from these drugs.
Hearing Health Science is also assessing the real world efficacy of Soundbites to conserve hearing and reduce the risk of hearing impairment from noise in invitation-only, epidemiological beta studies with music professionals, audio engineers, working musicians and avid music fans. The Soundbites beta is a second level, external pilot test under normal, everyday conditions. User participation will provide detailed feedback on real world performance prior to commercial launch.
“Preventable hearing loss is a large and growing global problem. Hearing protection devices are impractical or insufficient for many. Soundbites is a potential major breakthrough – a safe and effective micronutrient therapeutic, complementary to hearing protection and amplification devices,” said Barry Seifer, CEO of Hearing Health Science Inc. “The Soundbites clinical studies and beta tests represents important milestones after more than 25 years of research. Soundbites is starting its transition from the lab and the clinic to the general market.”
The Soundbites beta with professional musicians and audio engineers will be supervised by Michael Santucci, AuD, renowned audiologist and inventor of the Sensaphonics in-ear monitors used by the world’s top performing artists.
“Musicians, audio engineers and sound professionals have the keenest sense of hearing and a high risk of hearing loss, making for an ideal beta test group,” said Dr. Santucci. “Soundbites is one of the most exciting developments I’ve seen in my entire career in audiology. This product represents an entirely new approach to hearing health, and the preliminary research results are very promising. I am delighted to be working with Hearing Health Science to bring this new technology to the music industry.”
Noted University of Florida researcher Dr. Colleen Le Prell, a co-inventor on the University of Michigan patent, is leading Soundbites clinical studies and advising on the design of epidemiological studies to ensure valid baselines and control data against which valid comparisons can be made.
“The scope of the problem of hearing loss is beyond dispute,” said Dr. Le Prell. “The scientific evidence is also clear. Excessive unpaired electrons – so-call ‘free radicals’ – lead to irreparable damage within the delicate inner ear cellular structures, ultimately triggering cell death pathways that kill outer hair cells and cause permanent hearing loss. Antioxidant-based hearing preservation is a promising new therapeutic direction. I am delighted to be participating in the translational clinical and epidemiological research aimed at evaluating efficacy of this new therapeutic.”
The prominent University of Michigan public health researcher, physician and epidemiologist Dr. Howard Hu is collaborating with Dr. Le Prell, Hearing Health Science and Dr. Santucci to design and supervise those epidemiological studies. Up to 300 professional touring and performing musicians, audio engineers and avid music consumers will be invited to participate in the 90-day study.
“I am very pleased to be involved with Hearing Health Science and Soundbites, said Dr. Hu. “Hearing loss is a specific, prevalent and growing public health concern. Hearing therapeutics is a new area. The benefits of Soundbites are potentially global. Applying our epidemiologic research methods to Soundbites is an exciting opportunity.”
Dr. Josef M. Miller, among the top international hearing impairment research scientists, is the lead scientist responsible for Soundbites' groundbreaking research. Soundbites is the product of Dr. Miller’s career-long passion to eliminate preventable hearing loss, and two of Dr. Miller’s landmark discoveries provide the basis of the Soundbites patents and the Soundbites product line.
The first discovery was that hearing loss is caused by oxidative stress and decreased blood flow to the inner ear, similar to what happens in a heart attack or stroke. This was counter to conventional wisdom surrounding hearing loss, and a new way of understanding the problem.
The second breakthrough was laboratory studies demonstrating that high-potency dosing of vitamins A, C, E combined with magnesium prevented more than 80% of noise induced hearing loss.
Soundbites, directly derived from this science, is targeted at reducing noise-induced, drug-related, and age-related hearing loss. Soundbites is a safe, patented, pharmaceutical-grade hearing conservation supplement utilizing a precisely formulated blend of the antioxidant vitamins A, C and E, combined with the vasodilator mineral magnesium. Preclinical data suggest Soundbites users may be able to expect faster and more complete recovery from environmental noise trauma, conservation and preservation of healthy natural hearing, and less risk of permanent hearing loss and deafness caused by certain drugs. Clinical and epidemiological studies will also assess whether less severe symptoms like muffled hearing and ringing in the ears are also reduced.
Soundbites is licensed and produced by Hearing Health Science, Inc. a privately funded company headquartered in Ann Arbor, Mich. Ongoing research grant support for laboratory and clinical studies is provided by the Company, the U.S. National Institutes of Health and the European Commission Public Health Research Programme. More information is available at soundbites.org.