For Clinicians
ACEMg and Hearing Preservation
A peer-reviewed evidence base for clinical conversations about nutritional approaches to sensorineural hearing loss
This page is for audiologists, otolaryngologists, primary care physicians, and other licensed practitioners who want to evaluate the published evidence on ACEMg before discussing it with patients or integrating it into clinical workflows.
The published data, the raw dataset, and the patient handout are all freely available. We built this page so you can review the evidence on your own terms.
The clinical gap
Adults with early or mild sensorineural hearing loss (SNHL) who do not yet meet candidacy criteria for amplification currently have limited clinical options. The standard recommendation, annual monitoring plus noise avoidance, leaves a gap between diagnosis and intervention that can span years or decades.
ACEMg is a patented nutritional formula studied for its association with preserved cochlear function in adults with diagnosed SNHL. It is the subject of a peer-reviewed real-world evidence study published in March 2026.
ACEMg was developed at the University of Michigan Michigan Medical School Kresge Hearing Research Institute, supported by over three decades of preclinical and translational research funded by NIH and EU medical innovation grants.
Published evidence
Real-world evidence study (2026)
Design: Retrospective observational cohort study conducted within a single audiology practice. This is a real-world evidence study measuring effectiveness in routine clinical conditions, not a randomized controlled trial measuring efficacy under controlled conditions. This distinction matters for interpreting the findings.
Population: 190 adults with audiometrically confirmed SNHL. The ACEMg group (n=93) comprised patients who chose to take ACEMg daily and maintained adherence over the study period. The comparison group (n=97) comprised patients receiving standard audiological care without ACEMg supplementation.
Primary outcome measure: Distortion product otoacoustic emissions (DPOAEs), an objective measure of outer hair cell function that does not depend on patient self-report.
Key finding: 75.3% of daily ACEMg users maintained or improved DPOAE scores over a two-year follow-up period, compared to 26.8% of untreated controls.
Limitations acknowledged by the authors: Absence of randomization, potential for healthy-user bias, single-practice setting limiting generalizability, retrospective design. These limitations are inherent to the study’s real-world evidence methodology and are fully disclosed in the published paper.
Open access: The full text is freely available at pubmed.ncbi.nlm.nih.gov/41884353/
Raw data: The complete anonymized dataset is publicly available at osf.io/9xm4j, enabling independent verification and secondary analysis by any researcher or clinician.
Preclinical and translational research
The ACEMg formulation emerged from 36 years of NIH-funded and European Commission-funded research at the Kresge Hearing Research Institute, led by the late Dr. Josef M. Miller. The preclinical evidence base includes studies demonstrating that the combination of provitamin A (beta-carotene), vitamins C and E, and magnesium produces a synergistic effect on oxidative stress reduction in cochlear tissues that exceeds the effect of any individual component.
Relevant published preclinical work includes studies on noise-induced and drug-induced cochlear damage models demonstrating that ACEMg supports metabolic rescue of oxidatively stressed but structurally intact outer hair cells. The mechanism involves buffering free radical damage and supporting cochlear blood flow during and after metabolic insult.
A 2016 publication in Scientific Reports (Nature Publishing Group) by Green et al. demonstrated the formula’s relevance in a GJB2/Connexin 26 hereditary hearing loss model, extending the evidence base beyond acquired hearing loss.
For the full timeline of the underlying research program, see Research History.
Why real-world evidence, not an RCT
This is a question clinicians reasonably ask. The answer is straightforward.
ACEMg is a dietary supplement regulated under DSHEA. It has been commercially available to consumers throughout the study period. Any adult can purchase and take it without a prescription. In this context, the research team chose a real-world evidence design to answer the question most directly relevant to clinical practice: among adults with diagnosed SNHL who choose to take ACEMg daily in a routine clinical setting, does objective cochlear function change over time compared to those receiving standard audiological care alone?
This approach measures effectiveness, not efficacy. The distinction matters. Efficacy data from RCTs tell you whether an intervention can work under ideal, controlled conditions. Effectiveness data from RWE studies tell you whether it does work in the conditions your patients actually experience, with real-world adherence patterns and population variability.
The published effectiveness data provide a peer-reviewed evidence base for informed clinical conversations. The research program is committed to expanding this evidence through prospective observational data collection across a growing network of clinical sites and end users, with analysis and reporting to clinicians and the public by Keep Hearing Initiative under an IRB exemption.
Formulation
ACEMg contains four nutrients in a specific, patented combination and ratio:
| Ingredient | Role in the formulation |
|---|---|
| Provitamin A (beta-carotene) | Antioxidant; converted to vitamin A as needed. Studied for inner ear oxidative stress support. |
| Vitamin C | Water-soluble antioxidant supporting cellular defense in cochlear tissues. |
| Vitamin E | Fat-soluble antioxidant working synergistically with vitamin C. |
| Magnesium | Mineral supporting cochlear blood flow and nerve cell function under acoustic stress. |
The formulation is protected by two recent Soundbites patents: U.S. Patent No. 12,329,775 (Preserve or Improve Hearing and Reduce Dementia Risk) and U.S. Patent No. 12,472,203 (Composition and Method for Treating Hearing Loss, covering enhancement of auditory sensitivity associated with damaged auditory-nerve myelin). For the full patent portfolio and abstracts, see Patents.
Safety and contraindications
All four ingredients in ACEMg are common nutrients with established safety profiles at typical supplement doses. One consideration warrants specific clinical attention:
Beta-carotene and smoking risk: Research has demonstrated an increased lung cancer risk in current and recent smokers taking supplemental beta-carotene. The ACEMg daily dose delivers 10.8 mg of beta-carotene, which is below EFSA’s 15 mg reference point. However, current or recent smokers should discuss this specifically with their prescribing clinician before initiating ACEMg.
What ACEMg is and is not
ACEMg is a nutritional formula associated with preserved or improved objective hearing measures in a published, peer-reviewed real-world evidence study of adults with diagnosed SNHL.
ACEMg is not a drug. It does not treat, cure, reverse, or prevent disease. It does not replace hearing aids for patients who need amplification. It does not reverse existing structural damage to inner ear hair cells.
The appropriate clinical framing is as a nutritional adjunct to hearing preservation counseling for patients with diagnosed SNHL and ongoing noise exposure or age-related risk, used alongside noise reduction strategies and periodic audiometric monitoring.
Patient handout
We have prepared a patient-facing handout that you can download, print, and provide to patients. The handout is written in plain language and includes the published finding, an explanation of what the study did and did not show, the study limitations, common patient questions (including cost, insurance, safety, and the smoker warning), and links to the full open-access paper and raw dataset.
The handout includes a section for your practice name, visit date, and personalized notes.
You may reproduce this handout for clinical use without modification.
Wholesale practitioner pricing
Licensed practitioners can access wholesale pricing for in-office dispensing. Professional accounts include volume pricing, patient education materials, and access to clinical support resources.
Direct consumer purchase
Patients may also purchase ACEMg directly at shop.soundbites.com. The current subscription price is $33.99 per four-week supply (two softgels daily).
Clinical resources
The following materials are available for practitioners evaluating or recommending ACEMg:
- Patient Handout (PDF): Downloadable, printable, includes clinician notes section
- Published study (open access): PMID 41884353
- Raw dataset (open access): osf.io/9xm4j
- Practitioner evidence dossier: Available on request (clinicians@soundbites.com)
Additional clinical resources, including dosing protocols and follow-up monitoring recommendations, are in development and will be available in 2026.
Conflict of interest disclosure
Soundbites PBC is the commercial entity that produces and sells ACEMg. Barry S. Seifer, MFA, corresponding author on the published study, is CEO and co-founder of Soundbites PBC. All three study authors (Barry S. Seifer; Louise A. Minor, PhD, MD; and Richard A. Detweiler, PhD) are affiliated with the Research Department of Keep Hearing Initiative, the affiliated 501(c)(3) nonprofit that supports research on ACEMg.
The clinical data analyzed in the study were obtained from Lake Forest Hearing Professionals, a private audiology clinic in Lake Forest, Illinois. Records were extracted from the clinic’s electronic medical records and deidentified by licensed audiologist L.A. Halvorson before analysis. The original research program underpinning ACEMg was supported over a 36-year period by U.S. National Institutes of Health grants (NIDCD) to the late Dr. Josef M. Miller at the University of Michigan’s Kresge Hearing Research Institute, with additional funding from the European Commission.
Full funding sources, author affiliations, and conflicts of interest are disclosed in the published paper.
We disclose this prominently because we believe transparency about commercial relationships is essential to earning clinical trust. The data, the dataset, and the methods are public. We invite independent scrutiny.
Contact
For clinical questions, evidence requests, or practitioner account inquiries:
Email: clinicians@soundbites.com
Soundbites PBC is a Public Benefit Corporation. The affiliated Keep Hearing Initiative is a 501(c)(3) nonprofit supporting research, education, and global access to hearing preservation.
These statements have not been evaluated by the Food and Drug Administration. ACEMg is a dietary supplement and is not intended to diagnose, treat, cure, or prevent any disease.