- In this video, I'm talking about
the first possible cure for hearing loss, coming up.
(funky music)
Hi guys, Cliff Olson, doctor of audiology,
and founder of Applied Hearing Solutions,
in Phoenix, Arizona.
And on this channel,
I cover a bunch of hearing related information
to help make you a better informed consumer.
So if you're into that,
make sure you hit that subscribe button.
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Hearing loss is one of the most
common disabilities in the world.
In fact, the World Health Organization estimates
that about 5% of the entire world's population
has disabling hearing loss.
That equals about 466 million individuals.
Furthermore, they estimate that in 30 years from now,
that number's gonna rise to 900 million individuals.
Currently, hearing treatment
for sensorineural hearing loss,
which is the most common form of hearing loss,
can only be treated with devices like hearing aids,
and cochlear implants.
Sensorineural hearing loss is caused
when the inner or outer hair cells inside of the cochlea
become damaged, usually as a result of aging,
noise exposure or ototoxic medications.
This makes finding a cure for sensorineural hearing loss
something that is really high on the priority list,
especially for individuals who have hearing loss,
and any individual that communicates regularly
with someone else who has hearing loss.
Over the past several years,
a biotech company called Frequency Therapeutics
has been hard at work trying to develop a drug
to actually treat sensorineural hearing loss.
And that drug that they've been developing
is called FX-322.
Now according to Frequency Therapeutics,
"FX-322 is designed to treat the underlying cause
"of sensorineural hearing loss by regenerating hair cells
"through activation of progenitor cells
"already present in the cochlea."
The way that FX-322 is designed to work
is to use small molecules
designed to stimulate the dormant progenitor cells
already inside of the cochlea.
The drug is injected through the eardrum,
where the gel-like material
contacts the round window membrane,
allowing the molecular compound to diffuse into the cochlea,
and stimulate these progenitor cells.
In time, these progenitor cells
may be able to actually regenerate hair cells
that have been lost,
ultimately restoring the normal function of an ear.
Frequency Therapeutics is already completed
two phases of FDA trials.
The phase I safety trial was completed in early 2018,
and it was shown to not have
any adverse side effects of this drug,
on individuals who had already committed
to undergo cochlear implantation.
And their phase I, phase II trial
that was completed in April of 2019,
they tested the FX-322 drug
to see if it was safe in comparison to a placebo,
on individuals who had sudden sensorineural hearing loss,
or who had noise induced hearing loss.
And again, they found
that there was no serious adverse side effects.
The more exciting news
is that they actually showed improvement
in hearing function, in relation to word recognition scores,
where they showed about a 30% improvement
over the course of a 90 day window,
in the group of individuals
that was actually treated with the FX-322 drug.
The placebo group had no improvement
over that same period of time.
The other exciting news is that the treatment group
actually saw an improvement
in their word understanding in noise,
that would be more indicative of a social situation.
They saw an improvement of 20%,
verses only a 5% improvement in the placebo group.
The not-so-exciting news
is that there was significant improvement
in pure-tone thresholds.
So think the Xs and the Os on an audiogram,
there was no significant improvement in those Xs and Os,
meaning that their hearing sensitivity
had not really improved.
There were a few individuals in the study
that saw about a 10 decibel improvement at 8000 Hertz,
so that upper frequency range that we typically test,
but other than that it had really no big impact
on pure-tone thresholds.
This means that as of right now,
based on my interpretation of these results
is that this FX-322 drug shows promise
for regenerating the progenitor cells
that would stimulate inner hair cell growth,
but maybe not necessarily outer hair cell growth.
Inner hair cells are what control
the word recognition ability of an individual,
so your percentage correct on word scores,
whereas the outer hair cells typically are indicative
of what you would actually show on an audiogram,
with the Xs and the Os, and the pure-tone threshholds.
Now this information bodes really well
for individuals who already use hearing aids,
or who are willing to start using hearing aids,
but have bad word recognition.
But it doesn't bode so well for individuals
who are either putting off hearing treatment,
or who refuse to do hearing treatment,
because their waiting for some kind of a miracle cure.
Until we see improvements in the hearing sensitivity
of individuals, so think the Xs and the Os on the audiogram,
then you're still gonna have to utilize hearing aids
in order to gain audibility.
But if you're someone who has bad word recognition ability,
this drug could be a godsend,
meaning that your hearing aids
could actually be more effective for you.
The other good news coming out of this
is that the FDA has fast-tracked Frequency Therapeutics
phase II A clinical trials,
that will be exploring the ethicacy of FX-322,
verses the placebo,
for individuals with sensorineural hearing loss,
noise induced hearing loss,
and sudden sensorineural hearing loss.
The estimated completion date of this 96 participant,
210 day clinical trial, will be September 30th of 2020,
so go ahead and mark your calendars,
because we should be able to hear some exciting news
by the end of the year.
That's it for this video, if you have any questions,
leave them in the comments section below.
If you like the video, please share it,
and if you wanna see other videos just like this one,
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Also feel free to check out my website, drcliffaud.com.
(funky music)