Background: Hearing loss is a chronic disability that affects the lives and livelihoods for over 1.5 billion people worldwide. Hearing aids are the predominant treatment; however, their impact is modest, and they are less available in low- and middle-income countries where the need is greatest. Moreover, hearing loss is the #1 mid-life risk factor for dementia. Sensorineural hearing loss (SNHL), the most common form of hearing loss, is a metabolic stress disorder.
Objective: The micronutrient formula ACEMg was developed to block SNHL and successfully tested on animal models. We report real-world data (RWD) from a real-world evidence (RWE) study (N = 190) conducted to assess whether ACEMg impacts SNHL in humans.
Methods: This was a retrospective observational cohort study design with a historical comparison group. RWD from distortion product otoacoustic emissions (OAE) examinations were collected from patients previously diagnosed with SNHL. OAE testing is a recognized marker of cochlear health, producing objective measures of the auditory function of outer hair cells (OHC) in the cochlea.
Results: Analyses of RWD from OAE examinations in the treatment group (N = 93), who used ACEMg as softgel capsules, compared with OAE RWD from the untreated group (N = 97) suggest that ACEMg is significantly associated with the preservation and improvement of auditory function. Overall, OAE scores remained unchanged or improved for 75.3% of those in the ACEMg treatment group, as contrasted with 26.8% in the no ACEMg group. OAE scores over 2 years remained unchanged for 37.6% and improved for 37.7%. OAE scores decreased for 73.2% of those in the untreated group (X 2 2,190 = 55.94, P < .001).
Conclusion: This study yielded statistically reliable, objective, real-world clinical data suggesting a potential association between ACEMg supplementation and higher OAE scores over time, although alternative explanations cannot be excluded. These findings warrant additional investigation, given the widespread incidence of SNHL.
Keywords: ACEMg; antioxidants; dietary supplements; health promotion; hearing preservation; nutritional intervention; preventative care; sensorineural hearing loss.
© The Author(s) 2026.