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 (X²_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.

Search results

Impact of the ACEMg Biomedicine on Sensorineural Hearing Loss and Auditory Function: Analysis of Real-World Clinical Data