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ANN ARBOR, MICH — A two-year real-world evidence study evaluating ACEMg, a patented antioxidant formula developed through 36 years of NIH-funded research at the University of Michigan’s Kresge Hearing Research Institute, has been published in Global Advances in Integrative Medicine and Health and is now indexed on PubMed Central (PMC13010025).
The study analyzed distortion-product otoacoustic emission (DPOAE) data from 190 adults with diagnosed sensorineural hearing loss. Among 93 daily ACEMg users, 75.3% maintained or improved objective cochlear function over the study period, compared with 26.8% in the untreated historical control group of 97 patients (chi-square = 55.94, p < .001). Most measurable benefit emerged within the first six months of daily use and was sustained through 24 months of follow-up.
Barry S. Seifer, Soundbites CEOFor clinicians whose patients ask about nutritional approaches to hearing preservation, this study provides a peer-reviewed evidence base for informed conversation. We are not claiming ACEMg is a treatment for hearing loss. We are presenting the first published real-world evidence in this category, and we are inviting independent replication.
The research used DPOAE testing administered by credentialed audiologists. Unlike standard audiometric tests that depend on patient self-report, DPOAE provides an objective physiological measurement of outer hair cell function in the cochlea.
“For decades, the standard clinical position has been that age-related and noise-induced hearing loss is irreversible,” said Barry S. Seifer, corresponding author and CEO of Soundbites PBC. “This study does not contradict that position for severe damage. What it does suggest is that in patients with established sensorineural hearing loss who took daily ACEMg supplementation, objective cochlear function was preserved or improved more often than in untreated controls.”
ACEMg combines provitamin A (beta-carotene), vitamins C and E, and magnesium in a patented formulation designed to support the inner ear’s antioxidant defenses against oxidative stress. The formulation emerged from more than three decades of preclinical research at the University of Michigan led by the late Professor Josef M. Miller, the inventor of ACEMg, to whom the published paper is dedicated.
More than 25 peer-reviewed publications have characterized the mechanism in animal and cellular models, demonstrating that ACEMg supplementation is associated with reduced cochlear oxidative damage following noise exposure and during age-related decline. The newly published real-world evidence study extends this body of work into routine clinical practice with adult patients.
The authors selected a real-world evidence design rather than a randomized controlled trial because ACEMg is already commercially available as a dietary supplement under DSHEA and can be purchased without prescription. A placebo-controlled trial of an over-the-counter product available to any participant raises ethical and practical questions about adherence and access.
The real-world design captures effectiveness under actual clinical conditions: real patients, real adherence patterns, and routine audiological follow-up. The authors fully disclose the limitations inherent to this design, including the absence of randomization and the potential for healthy-user bias. They note that future randomized controlled trials are warranted to confirm these findings.
The full anonymized dataset is publicly available on the Open Science Framework, an unusual standard of transparency for the dietary supplement category.
Sensorineural hearing loss affects approximately 466 million people worldwide and has been identified by the Lancet Commission as the leading modifiable risk factor for dementia. No pharmacological interventions are currently approved for treatment or prevention of age-related or noise-induced sensorineural hearing loss. A series of high-profile drug development programs targeting hair cell regeneration have terminated in late-stage failure over the past five years.
“For clinicians whose patients ask about nutritional approaches to hearing preservation, this study provides a peer-reviewed evidence base for informed conversation,” said Seifer. “We are not claiming ACEMg is a treatment for hearing loss. We are presenting the first published real-world evidence in this category, and we are inviting independent replication.”
ACEMg is regulated as a dietary supplement under the Dietary Supplement Health and Education Act (DSHEA). Barry S. Seifer is co-founder and CEO of Soundbites PBC, which holds the exclusive commercial license to ACEMg. This conflict of interest is disclosed in the published study. The research was supported by Keep Hearing Initiative, the affiliated 501©(3) nonprofit.
Soundbites is a Public Benefit Corporation legally bound to balance commercial objectives with its public health mission: to measurably reduce the global burden of sensorineural hearing loss. ACEMg is the first commercial product translation of more than three decades of academic hearing preservation research at the University of Michigan.
SOURCE: Soundbites
