About Hearing Loss
Humans are born with about 15,000 hair cells in the cochlea of each ear. Hair cells are commonly lost due to noise exposure in work settings or as a result of aging, certain viral infections or exposure to medicines that are toxic to ears.
Lost Sensory Hair Cells and Hearing
These lost hair cells do not spontaneously regenerate, leading to progressive degrees of hearing loss. This condition is called sensorineural hearing loss (SNHL), which impacts more than 90 percent of all people with hearing loss.
While hearing loss is often thought to be caused by aging, the condition is strongly correlated with living in an industrialized society and associated noise exposure and other environmental factors.
A Growing Public Health Problem
Fifteen percent of adults globally have some degree of hearing loss, and that number is expected to rise to 22% by 2060.1 Another 1.1 billion people between the ages of 12 and 35 are at risk of hearing loss,2 as exposure to recreational noise increases.
Hearing loss also comes at a cost. Recent research has linked the condition to increased risk of social isolation, depression and cognitive decline.3 It is also associated with poor health care outcomes, higher health care costs and higher unemployment rates.4
Our Approach to Regenerating Lost Cochlear Hair Cells
Frequency’s lead program, FX-322, is designed to activate progenitor cells in the inner ear to regenerate damaged auditory cells and repair hearing loss. A Phase 1/2 study has demonstrated a statistically significant and clinically meaningful improvement in key measures of hearing loss, including clarity of sound and word recognition, and a favorable safety profile.
FX-322 is designed to be a disease-modifying therapy that repairs the underlying biology that causes hearing loss.
FX-322 is administered through the eardrum (intratympanically) and into the middle ear in a procedure that takes approximately 10 to 15 minutes, and is a routine, office-based procedure for ear, nose and throat specialists.
Addressing Sound Clarity and Word Recognition
The two primary ways to measure hearing are intelligibility, or the ability to understand spoken words, and the audibility, or loudness, of sound.
Today, there are no FDA-approved medical therapies for the treatment of hearing loss. While amplifying devices such as hearing aids can make sounds louder, they have limited ability to improve intelligibility, particularly in noisy environments. Intelligibility is particularly important to understand speech in social settings such as in meetings or at restaurants, where filtering sound is critical for communication.
- Goman, A, et al. Addressing Estimated Hearing Loss in 2060. JAMA Otolaryngol Head Neck Surg. 2017 Jul; 143(7): 733–734.
- World Health Organization (WHO). Deafing and Hearing Loss. (epub/last updated March 1, 2020)
- The Hearing Review. Hearing Loss and Associated Comorbidities: What Do We Know? (epub Nov. 30, 2017)
- Reed, N, et al. Trends in Health Care Costs and Utilization Associated With Untreated Hearing Loss Over 10 Years. JAMA Otolaryngol Head Neck Surg 145(1): 27–34 (2019)