LEGAL

ACEMg is not a pharmaceutical. ACEMg is a nutritional supplement comprised of the antioxidant micronutrients vitamins A, C, E and the mineral Magnesium. These ingredients are classified Generally Regarded As Safe (GRAS) by drug agencies in the EU and USA and others. Hearing Health Science makes no claim that ACEMg will prevent, treat or cure hearing loss, tinnitus or any other disease or disorder. These statements have not been evaluated by drug agencies.

Mechanism of Action
Disclaimer

Each of the antioxidant micronutrients and the mineral in the ACEMg formulation acts within cells to supplement endogenous antioxidant systems to help maintain normal cell function and metabolism, reduce oxidative stress and subsequent metabolic disorder, cell damage and cell death. This mechanism of action happens throughout cells of the body. In replicated lab studies published in peer reviewed medical journals, ACEMg has been shown to stop excess inner ear free radicals from forming and prevent vasoconstriction and dilation to help maintain normal functioning of inner ear hearing cells (including but not limited to hearing sensory cells, auditory nerve cells, afferent and supporting cells) and help maintain normal inner ear blood flow. Specifically, ACEMg has been demonstrated to block the release of the vasoconstrictor isoprostane 8-iso prostaglandin F2a, thus reducing the ischemia/reperfusion “choke-and-release” response this isoprostane, further reducing excess inner ear free radicals and inner ear oxidative stress. Lab studies demonstrate ACEMg can provide more than 30dB of protection to inner ear hearing cells when they are exposed to damaging levels of intense sound and noise.

Patents
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Soundbites is the brand for the micronutrient formula ACMg. ACEMg hearing preservation and tinnitus patents are owned by the University of Michigan and licensed exclusively to Hearing Health Science. ACEMg covered by US Patents:

  • 8,927,528, a composition consisting essentially of antioxidant micronutrient vitamins A, C, and E, and the vasodilator mineral Magnesium (Mg) – together, the composition ACEMg –  for treating hearing loss;
     

  • 7,951,845, method of treatment for hearing loss; 
     

  • 8,338,397, method of treatment for hearing loss side effects of aminoglycoside antibiotics;
     

  • 8,338,398, method of treatment for hearing loss after mechanically-induced metabolic trauma, stress trauma or stress-induced damage originating in the environment (exogenous) or within the ears (endogenous)’
     

  • 9,144,565, method of treating hearing loss from certain genetic mutations including Connexin 26 (Cx26), after peroxyl radical formation, lipid peroxidation, vasoconstriction or formation of lipid peroxyl radicals within a lipophilic compartment of a mitochondrial membrane;
     

  • 15/272,981, method of treating Age-Related Hearing Loss (ARHL);
     

  • 15/272,973, method of treating Noise-Induced Hearing Loss (NIHL) from ongoing, repeated exposure to intense sound or noise;
     

  • 9,770,433, method of treating temporary and permanent tinnitus

Funding &
Investors
FDA Information

Dietary Guidance
The recommended daily dose is two softgel capsules swallowed daily. Do not chew the capsules. Follow these instructions if you cannot swallow capsules. Open the end of the capsule with a knife or scissors.  Squeeze the contents into yogurt; the formula will mix easily. The formula will not mix into water-based liquids.

 

Structure/function claims
Soundbites is a nutritional supplement subject to the Food and Drug Administration (FDA) regulatory claim statutes of the Dietary Supplement Health and Education Act (DSHEA). 

 

Soundbites is the pure, high-potency multi-patented formula ACEMg comprised of antioxidant micronutrient vitamins A, C, and E, and the vasodilator mineral Magnesium (Mg). ACMg helps maintain normal healthy structures and functions of the inner ear. are considered to be structure/function claims. 
 

Soundbites helps preserve hearing by eliminating excess inner ear free radicals that cause oxidative stress, maintaining the healthy structure and function of inner ear cells and promoting inner ear blood flow. 
 

These dietary guidance and structure/function claims have not been evaluated by the FDA. Soundbites is not intended to diagnose, prevent or treat any disease.

Basic research and ACEMg R&D was developed over three decades with about $25 million in government grants from the US National Institutes of Health and the European Commission. Hearing Health Science, Inc. (HHS), founded in 2010, is a for-profit company with a social impact mission to bring ACEMg to the world market,  HHS is funded by accredited American and European investors. For more information, contact investors@hearinghealthscience.com.