Whether it be a breathtaking symphony or heartfelt conversation across the dinner table with family and friends, sound plays a pivotal role in our everyday lives. Without this aspect of life, study after study concludes our quality of life, happiness, and relationships can greatly suffer. Unfortunately, this is the reality for over 48 million Americans suffering from mild to moderate hearing loss on a daily basis. With that population projected to grow exponentially by 2050 due to lack of access to hearing loss treatment options, the need for new treatments has become dire, a need the pharmaceutical company has quickly realized. Despite the projected growth by the CDC, not one FDA-approved drug is available for the treatment or prevention of inner ear disorders, leading to a swell of new hearing loss companies dedicated to this very problem and paving the way for a revolution in hearing loss treatment.

Why Has It Taken This Long?

Although the deaf or hard of hearing population is expected to grow in the coming decades, targeting the inner ear has been a complex problem for medical professionals due to a lack of previous experience. Hugo Peris, the founder and CEO of Spiral Therapeutics, laments “The lack of previous clinical experience in the inner ear field represents a big challenge for companies developing drugs in this space.” Despite the lack of previous clinical history, Peris sees this as an incredible opportunity. 43 companies are now developing inner ear therapies and drug delivery systems, and that number is growing. Ranging from hair-cell regeneration to combatting ototoxicity, these companies are revolutionizing inner ear treatment with products already in pre-clinical and clinical trials and a timeline of release within the next few years.

Drug Delivery Systems and The Inner Ear

Though this progress is promising, another highly important factor is impacting the speed of how quickly these drugs are developed. “The drug delivery system, specifically, determining the appropriate delivery system that will most safely and effectively transport the medication in the desired manner, while also prioritizing patient comfort,” notes Sueanne Phan, a member of the Student Academy of Audiology Communications Committee, “For inner ear drugs, this task is not as simple as transdermal delivery for a flu shot or oral drug delivery for cough syrup.”
Notable challenges face researchers when choosing the proper drug delivery system for the inner ear, particularly when translating pre-clinical trial results, where animal models are used, into human-friendly treatments. “The challenge is in translating positive results of preclinical settings into the clinic. The inner ear is an extremely complicated and sensitive organ that is hidden in the skull and presents great differences in size among different species,” said Peris. “What has worked in a rat can’t be expected to correlate fully in humans in pharmacokinetic terms.”
These among many other complications can present roadblocks for new innovative inner ear drugs, though companies remain hopeful about the positive change they can bring to the hearing loss community. Charles Pudrith, AuD, PhD, assistant professor of Audiology at Northern Illinois University explains, “patients may be more willing to seek treatment for hearing loss if there were pharmaceutical treatment options.”