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, suddenly, 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.

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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

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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. Three clinical studies in which a single dose of FX-322 was administered have shown hearing improvements in measures of speech perception. In addition, FX-322 was observed to be well-tolerated with no serious adverse effects.

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.

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Addressing Sound Clarity and Speech Perception

The two primary ways to measure hearing are speech perception, or the ability to understand spoken words, and 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 speech perception, particularly in noisy environments. Speech perception is particularly important in social settings such as in meetings or at restaurants, where filtering sound is critical for communication.

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  1. Goman, A, et al. Addressing Estimated Hearing Loss in 2060. JAMA Otolaryngol Head Neck Surg. 2017 Jul; 143(7): 733–734.
  2. World Health Organization (WHO). Deafness and Hearing Loss. (epub/last updated March 1, 2020)
  3. The Hearing Review. Hearing Loss and Associated Comorbidities: What Do We Know? (epub Nov. 30, 2017)
  4. 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)