Our Sensorineural Hearing Loss Program

Sensorineural hearing loss, or SNHL, is the most common form of hearing loss and results from damage to the hair cells in the inner ear or problems with the nerve pathways that convert sound waves from the inner ear to the brain. These hair cells can be lost due to chronic noise exposure, aging, certain viral infections or exposure to drugs that are toxic to the ear.

The human ear does not spontaneously restore lost or damaged hair cells, making hearing loss a permanent condition. Today, there are no FDA-approved therapeutic options for SNHL.

FX-322 is designed to treat the underlying cause of sensorineural hearing loss (SNHL) by regenerating hair cells through activation of progenitor cells already present in the cochlea.

Two clinical studies in which a single dose of FX-322 was administered have shown statistically significant and clinically meaningful improvements in speech intelligibility. In addition, FX-322 was observed to be well-tolerated with no serious adverse effects. We continue to study FX-322 across a broad range of etiologies and populations so we can better understand the individuals our therapeutic candidate may treat.

Frequency’s Approach to Regenerating Lost Cochlear Hair Cells

World Health Organization (WHO) estimates show that approximately 1.5 billion people have hearing loss globally and has reported that today more than a billion young people are at risk of hearing loss. According to the US National Institutes of Health, approximately 90 percent of those with hearing loss are affected by sensorineural hearing loss. Noise exposure is difficult to avoid in modern society and, based on our estimates, we believe that 41 million people in the United States alone may have SNHL, based on numbers of diagnosed and undiagnosed.

There are also further direct and indirect impacts on individuals suffering from SNHL. Hearing loss can profoundly effect an individual’s ability to participate in social interactions, which can lead to feelings of loneliness, isolation, and frustration. Untreated hearing loss is also correlated with dementia and depression.