ANN ARBOR, MICH – Soundbites, a Public Benefit Corporation dedicated to hearing preservation for everyone, today announces that the United States Patent and Trademark Office (USPTO) has issued patent 12,329,775. The patent covers a nutraceutical, known as ACEMg® in medical literature and sold under the Soundbites® brand as softgel capsules, designed to preserve or restore hearing in people who have already experienced hearing loss unrelated to viral infection.

“I have found ACEMg to be of clear benefit for patients. These real changes are clinically important. The significance of this achievement cannot be overstated,” says Dr. Glenn Green, M.D., Kresge Hearing Research Institute at the University of Michigan.

According to the allowed claims, daily dosing over at least three months can improve hearing thresholds by 15% or more, measurable through distortion-product otoacoustic (OAE) emissions across frequencies from 1 kHz to 10 kHz. Additional claims extend the use of the ACEMg formulation to lowering the severity or risk of dementia and Alzheimer’s disease in at-risk individuals with, or likely to develop, sensorineural hearing loss (SNHL).

“The new patent is more than a legal milestone—it’s a big step forward for hearing health,” says Barry Seifer, Founder and CEO. “Soundbites has translated 20 years of auditory research into a daily supplement, and this patent safeguards our ability to continue advancing clinically-backed innovation to protect and preserve the ability to hear.”

Explanation of the science behind Soundbites from the Keep Hearing initiative which sponsors and manages the OTIS study.

SNHL, or inner ear hearing loss, is one of the most common and incurable chronic health disabilities worldwide, impacting about 1.5 billion people. Another 1.4 billion young adults ages 12-35 are considered at risk, mainly from exposure to loud music at bars, clubs, festivals, and from personal music players. Common consequences of SNHL include tinnitus, hyperacusis, and hidden hearing loss, and hearing preservation is now understood to be the major risk mitigating factor for dementia.

Clinical findings from a two-year, real-world study are the basis for the follow-on, IRB-approved OTIS Study now underway. This 24-week, Phase IV, open-label, post-marketing real-world evidence/real-world data (RWE/RWD) study on ACEMg is being conducted by participants at home, testing the ACEMg impact on synaptopathy, tinnitus, and hyperacusis.

For more information on hearing health and preservation, the ACEMg supplement, or to participate in the OTIS study (limited initially to 200 adults aged 18 and older, residing in the U.S.) please visit Soundbites.com.

Source: Soundbites

Related studies

Alvarado JC, Fuentes-Santamaría V, Melgar-Rojas P, Gabaldón-Ull MC, Cabanes-Sanchis JJ, Juiz JM. Oral Antioxidant Vitamins and Magnesium Limit Noise-Induced Hearing Loss by Promoting Sensory Hair Cell Survival: Role of Antioxidant Enzymes and Apoptosis GenesAntioxidants. 2020; 9(12):1177.

Le Prell CG, Hughes LF, Miller JM. Free radical scavengers vitamins A, C, and E plus magnesium reduce noise trauma. Free Radic Biol Med. 2007 May 1;42(9):1454-63. doi: 10.1016/j.freeradbiomed.2007.02.008. Epub 2007 Feb 20. PMID: 17395018; PMCID: PMC1950331

About Soundbites

Soundbites is a Public Benefit Corporation dedicated to hearing preservation for everyone, changing the convention that hearing loss is inevitable with the world’s first clinically proven, affordable, preventive care biomedicine for hearing. Grounded in decades of research from Dr. Josef Miller at the University of Michigan Medical School, Soundbites offers the first scientifically backed antioxidant supplement, ACEMg, for hearing preservation. Soundbites’ mission is to make lifelong hearing preservation accessible to everyone, reducing the personal, social, and economic burdens of hearing loss.