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Hearing restoration drug FX 322 - A new drug said to reverse hearing loss

By: Paul Harrison Updated: 16th June 2022 in: Flash Audiology News, Latest News, Articles, Hearing Loss Awareness
Could the FX 322 drug cure hearing loss?

Could the FX 322 drug cure hearing loss?

The science, the trials and the reality


A new drug, the FX 322, is said to reverse hearing loss

Research is currently being undertaken, by Frequency Therapeutics, on a new gel-based drug that is injected into your ear designed to promote stem cell growth.  This will regenerate and develop hair-like stereocilia cells said to reverse hearing loss

A procedure that hopes to be performed in ENT clinics in the future.  Let's take a look at the science, trials, and reality behind this new drug for hearing loss. Is this really a cure?


How does it work?

The drug, named FX-322, is an injection that is said to work by stimulating the dormant stem cells inside your ear to grow new healthy auditory cells that send sounds to your brain for you to process and understand.  It is said to be delivered into the middle ear and absorbed by the inner ear.


What are stem cells?

Throughout your body, you have stem cells that are incomplete and usually have the ability to develop into any form of tissue. This particular drug encourages them to grow into stereocilia, which are hair-like cells in your ears that detect sound.  Hearing loss is when these hair cells are irreversibly damaged, as they cannot repair themselves.

Today, hearing aids are the most successful form of treatment for amplifying sound.  These early studies hope to restore sensorineural hearing loss (SNHL).   Sensorineural hearing loss is the most common type of loss caused by aging, genetics and prolonged exposure to loud sounds.  However, it is one thing to grow hair cells, getting them to work is another thing entirely.


Simplifying the science

The FX 322 gel contains drugs that early studies indicate helped to aid new hair cell formation.  These are called progenitor cells, which are unable to evolve into any body tissue.  Instead, they are usually more inclined to develop into cells near where they are found in the body. 

So the progenitor cells in the ear will more than likely turn into tiny hearing cells.  In short, this drug is designed to assist in helping molecules activate these cells to regrow the lost sensory cells.  These cells are needed to filter and tune sounds.  


FX 322 drug testing and trials

The research is still in its infancy with a lot of 'ifs', 'buts', and various hoops to jump through before this drug will be signed off for larger-scale human trials.  There have been only small trials (around five clinical studies) so far with researchers stating that this new drug may help hearing, such as the clarification of sound, speech perception, and understanding with hair cell regeneration.

With each study undertaken, the scientists behind this research add to their overall understanding of the FX 322 drug with some speech perception improvements which was published in Otology & Neurotology.  However, from our understanding of the studies that followed, the drug showed no signs of improvement when compared to the placebo - rendering the evidence inconclusive.


 Is there a cure for hearing loss

The FX 322 Drug

The reality


No hearing loss cure yet - To summarise

There are talks of an evolved version of the FX 322 drug, called  FX 345, and that these clinical studies may roll out towards the end of this year.  How valid these rumours are is hard to say, as trials have been disappointing so far and investors are actively trying to sue them for false claims about the clinical trials.

Currently, there is no drug or treatment to repair the sensory system and in reality, the full restoration of hearing is not just debatable, but unlikely.  FX 322 is a novel and experimental drug that is still in the developmental phase, therefore this does mean that if you think your hearing has worsened - hearing aids are still the most successful treatment for the foreseeable future.

What is clear is that the more we research the causes and treatments of hearing loss - the more we understand it.  However disappointing, trials are still a very important part of audiology research.  Such research ultimately influences the evolution of hearing aid technology in the future.  Making them better, more efficient, more personable, more powerful.


Think your hearing has changed?

If you think your hearing has worsened - book a free hearing healthcare consultation with one of our audiologists to check how well you're hearing today.  Call us free on 0800 567 7621


FX 322 drug developed by Frequency Therapeutics and the Massachusetts Institute of Technology in the U.S


Read Next:  The genes that link to hearing loss

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This article was written by audiology expert Paul Harrison

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Managing Director & founder of Hearing Aid UK, with over 20 years of audiology experience and a member of the British Society of Hearing Aid Audiologists Council (BSHAA) between 2015-2020.

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