The antioxidant formula of beta-carotene (metabolized to vitamin A), vitamin C, vitamin E and magnesium is known as ACEMg and is sold under the Soundbites brand as softgel capsules.
Beta carotene scavenges singlet oxygen, vitamin C scavenges free radicals that escape scavenging by beta carotene and vitamin E, and vitamin E acts as an 8-iso prostaglandin F2 alpha antagonist—all of which have been implicated in hearing loss.
Background
SoundBites’ origin dates back to the late 1980s with auditory neuroscience research by Dr. Josef Miller at the University of Michigan Medical School. Shortly after, he became director at the Kresge Hearing Research Institute. Dr. Miller hypothesized that hearing loss could be explained biologically, and decades later, he was able to prove his theory through extensive research.
In 2010, Barry Seifer joined Soundbites Public Benefit Corporation (PBC), which holds the exclusive patent license to the ACEMg hearing preservation biomedicine developed at the University of Michigan Medical School. Since 2010, Seifer has been working in translational research to bring ACEMg out of Dr. Miller’s laboratory and into the market.
Patent no. 12,329,775
This marks the 10th patent for the Public Benefit Corporation dedicated to hearing preservation.
Seifer, co-founder and CEO of Soundbites PBC, told NutraIngredients that the newest addition to the company’s patent portfolio is the most significant to date and the result of 15 years of translational research.
“It is based on data from a 2-year, Phase IV (open label, post-marketing, non-randomized clinical study [N=193]) that found ACEMg (Soundbites) preserved or improved hearing for 75.3% of participants within 6 months of daily use,” he said. “Results were durable with ongoing use. These findings are unprecedented in hearing clinical research. In addition to patent claims for hearing preservation and hearing restoration, the patent contains additional claims for reducing dementia risk.”
He added that the patent safeguards Soundbites’ ability to continue advancing clinically-backed innovation to protect and preserve the ability to hear.
“The patent represents the starting line for executing the public health mission Dr. Joe Miller and I wrote in 2010: Measurably reduce the worldwide social and economic burdens of hearing loss and its related neurological consequences (tinnitus, hyperacusis, hidden hearing loss, and dementia),” Seifer added. "The patent gives us 20 years to get that done.”
Sound science
According to the allowed claims, daily dosing over at least three months of ACEmg (Soundbites) may improve hearing thresholds by at least 15%, measurable through distortion-product otoacoustic (OAE) emissions across frequencies from 1 kHz to 10 kHz.
Common consequences of SNHL include tinnitus, hyperacusis and hidden hearing loss.
SNHL, or inner ear hearing loss, impacts about 1.5 billion people across the globe and is one of the most common and incurable chronic health disabilities in the world, according to the World Health Organization (WHO). Additionally, 1.4 billion young people ranging from ages 12 to 35 are also considered at risk, mostly due to exposure to loud music.
‘The biggest advance in audiology since the hearing aid’
Seifer told NI that for over two centuries, it has been widely accepted that hearing loss is inevitable and the main solution to manage it after it occurs is with hearing aids.
“Soundbites (ACEMg) challenges that idea,” he said. “Instead of accepting hearing loss as something to treat after the fact, Soundbites shifts the focus to prevention, protection and long-term hearing health.
“Soundbites (ACEMg) is a clinically proven way to preserve hearing before loss occurs, or slow down or even modestly reverse the loss after it occurs. Significantly, hearing preservation is now understood to be the best way to reduce the risk of dementia, which means Soundbites is also preventive care for cognitive health.”
Soundbites’ research team has developed the Otology Intervention Study (OTIS), a 24-week remote trial that opened enrollment in December 2024 (ClinicalTrial.gov).
For anyone interested, participation is free and all new Soundbites customers can participate using the OTIS Study protocol by purchasing test kits at a discount.
Soundbites also has four more patents in the pipeline, according to Seifer.
“Ultimately, we believe Soundbites will become the biggest advance in audiology since the hearing aid,” he said.
