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CLINICAL INDICATIONS

Free radicals function as triggers to upregulate necrotic and apoptotic pathways to cell death. The scientific rationale underlying Soundbites is that free radical formation defines a final common cell death pathway inducing pathology from a variety of etiological factors amplified by reduced organ circulation, which is a dramatic feature of noise-induced stress and a significant feature of the cellular aging process in nonsyndromic hearing impairment etiologies including genetic hearing loss, the ototoxic side effect of certain drugs, and certain viruses.

GJB2/connexin 26

Hearing impairment is the most common congenital sensory impairment. Mutations in one gene, GJB2, which encodes the connexin 26 protein and is involved in inner ear homeostasis, are found in up to 50% of patients with autosomal recessive nonsyndromic hearing loss. (American Journal of Human Genetics, 2005).

Dr. Glenn Green, a pediatric otolaryngology physician and research scientist at the University of Michigan Medical School, used the Soundbites formula, known as ACEMg in scholarly medical literature, to treat a boy with GJB2 connexin 26 genetic hearing loss. The case report was published in the International Journal of Pediatric Otorhinolaryngology in 2014. From the abstract: 

“Antioxidants have been associated with attenuation of hearing loss from other insults. One antioxidant regimen consists of beta-carotene (metabolized to vitamin A), vitamin C, vitamin E, and magnesium (ACEMg). We present a child with Connexin 26 related hearing loss who experienced progressive hearing loss over 7 years of observation. He was given ACEMg daily for 3 years, during which time his progressive hearing loss was ameliorated.”

Dr. Green and several others published a preclinical study on GJB2 connexin 26 titled ACEMg Diet Supplement Modifies Progression of Hereditary Deafness in Nature/Scientific Reports (April, 2016; PMID 26965868). Their results indicated that the “ACEMg supplementation can influence the progression of genetic hearing loss.”

Soundbites holds US Patent No. 9,144,565, a method of treating genetic hearing loss caused by Connexin 26 mutations and upregulation of free radicals that cause hearing loss after peroxyl radical formation, lipid peroxidation, vasoconstriction or formation of lipid peroxyl radicals within a lipophilic compartment of a mitochondrial membrane.

Hearing loss induced by certain drugs

ACEMg has been demonstrated to be beneficial for reducing hearing loss due to aminoglycoside antibiotics that upregulate inner ear free radicals [Assessment of Nutrient Supplement to Reduce Gentamicin-Induced Ototoxicity, J Assoc Res Otolaryngol. (JARO) 2014 Jun; 15(3): 375–393]. ACEMg holds US Patent No. 8,338,397 as a method of treating the ototoxic side effects of aminoglycoside treatment.