Covid-19 Vaccine Side-Effects on Tinnitus | Dr. Robert DiSogra

(upbeat music) – Hello and welcome, this is episode 16 of the Pure Tinnitus and Hearing Podcast. Today we are with Dr. Bob DiSogra. Dr. DiSogra is a former Adjunct Professor and lecturer of Pharmacology
at University of Pacific, Salus University and Kean University. We are here today to talk about
over-the-counter medications and herbal supplements
for tinnitus, side effects of COVID-19 and side effects
of the COVID-19 vaccine, how that affects tinnitus. Additionally, we're going to
talk about the relationship between antidepressant,
prescription medications, their effect on tinnitus
and last but not least, the drugs FX-322, OTO-313 and other drugs that are being researched
to help treat hearing loss, which could improve tinnitus. Dr. DiSogra, tell us how you're doing, where you're coming from and how you serve the audiology community. – Well, thank you Ben for
inviting me this afternoon, I really appreciate this
a great opportunity for me to put some good solid
information out to your viewers about tinnitus and the
different causes and management.

I'm in Millstone, New Jersey. I'm in Central New Jersey, I've had a private practice
in Freehold for over 30 years and I think this is my
43rd year in audiology. So, I've had some clinical
work, research work, industrial work, I've had a
wide variety of audiology, different backgrounds and
different jobs in audiology. But the private practice
was my bread and butter for 30 years in Freehold and the teaching opportunities came along.

So, I've been blessed, I really have. So, I'm really here to help
your audience with any answers to the questions that they
might have through you about over-the-counter
tinnitus relief products and dietary supplements. So, let's get the party started. – Yeah, let's get started by talking about over-the-counter
medications and herbal supplements that are marketed, labeled
for helping tinnitus. I'm very active in the
online tinnitus community and one of the common posts people make in the Facebook groups are a
picture of an advertisement and saying, hey, has anyone
tried this, does this work? You are an expert in
the prescription drugs, you're an expert in medications and classifying their validity on tinnitus as well as hearing loss.

So, give us the quick overview on, what are the takeaway points
you want someone to know about over-the-counter medications and herbal supplements for tinnitus? – Well, the first
takeaway is the fact that the food and drug
administration classifies, dietary supplements as food. And as food, it does
not have to go through the rigorous evidence-based research, that pharmaceuticals have to go through to get approval by the FDA
for safety and efficacy, or does it work, okay? So what happens is that
you have a food product and there are a lot of
gray areas in the law when it comes to marketing these products for whatever the manufacturer is intending the product to be used for. So according to federal law, if I'm a manufacturer
of a dietary supplement, in order for me to sell this
product in the United States, I have to notify the FDA,
fill out some documentation and register my company. So when I get the approval
to sell the product, my company is FDA registered,
not the product for tinnitus. What happens is that, when I get that okay to sell the product, technically I'm cleared
to sell the product.

So I have the green
light and the blessings of the FDA to sell the product. Now, so here I am I want
to sell this product, I don't have to provide any proof at all to the FDA about safety and efficacy. So, I want to attract
people to buy the product, so I will use words like, well,
my product is FDA registered and my product is FDA
approved, so prove for sale. The company is registered with the FDA, it's not approved for tinnitus.

There are over 80 products available on the market right now, from my research that are FDA registered,
but none of them, zero, none of them are FDA
approved for tinnitus. So, when you purchase a
product that's marketed and it's pretty slick marketed, when you purchase a
product that's marketed for tinnitus relief, keep
in mind several things. It may not be a safe product, there may be ingredients in that product, that may be harmful,
harmful for pregnant women, may be harmful for patients that have cardiovascular disease, there is no system of checks and balances. So, the good news here is that if there is an adverse reaction
to a dietary supplement, whether it's for tinnitus or whatever else it's being used for, including any essential oils, the FDA has a special program
called the MedWatch program, M E D, MedWatch program. And you can go online to the FDA website, they know, just key in, MedWatch, and I think it's 1-800-MedWatch
is the phone number. And you can report this any adverse event that you have to the FDA and hopefully they will follow through.

Now, given the fact that of
all of the different issues that we have in this country right now, where is tinnitus on
the list of importance? So, there may be some delay
in getting a response to that. So, there is a system of checks
and balances to consumers, if they're not satisfied with the product or they have an adverse reaction
to the dietary supplement. And what's even more
interesting here, Ben is that, the MedWatch program is the same program that you voluntarily
report an adverse reaction to a pharmaceutical, to an
FDA approved pharmaceutical. So the MedWatch program
covers prescription drugs and over-the-counter supplements. – Okay so, when we're walking this through for someone who is online
looking for tinnitus help, we have to remember that
when they search on Google for anything related to tinnitus, typically the first few posts that show up on the
feed are advertisements.

And I've of course searched
tinnitus may times, many of the people looking
for help are then hit with these advertisements
for herbal supplements. So Bob, how would you advise
someone who is interested in taking a pill for tinnitus, if they come into your
clinic and they say, hey doc, are there any pills
I can take for tinnitus? Is there anything I can eat or any kind of herbal
supplement that might work? How do you counsel them? – First thing I let them
know is what I just said in the beginning, there are no FDA approved
products for tinnitus relief.

So, really at that point I
try to empower my patients to make an informed decision, how they want to spend their money. I counsel my patients that your tinnitus is a side effect, okay? To you it's a complaint,
but to me and to you Ben, tinnitus is a side effect,
something is causing that. And I think that's the road
patients have to look at. They'll go right after the
complaint and overlook the cause, it's like having pain in your hand, you don't take an aspirin for the pain, you try and get the nail
out of your hand, okay? If I can use that analogy, okay? So, I counsel my patients about a cause.

Now, again we know tinnitus
can be a side effect with certain types of hearing loss. We know what's a side effect of a lot of cardiovascular medications. We know that tinnitus could occur in patients with diabetes,
especially younger patients because there are studies that show that patients that have some hearing loss, that are under the age of 60, there's about a 50 to 60%
chance it could be prediabetic. So, there's a lot of new information, very exciting information
that's coming out as far as tinnitus as a cause from diabetes and other
underlying clinically silent, were a very clinically active disease. – And you touched on
something interesting there that sometimes tinnitus can be caused by certain medications. What are the common conditions, you mentioned, high blood pressure, what are the common situations that someone will get
tinnitus as a side effect, and can you touch on how common it is for a prescription drug to
list tinnitus as a side effect? – Well, first of all, the
food and drug administration, when a manufacturer, when
a pharmaceutical company, is doing ethical clinical trials, they have to establish safety and efficacy very early
on in the research.

We saw that with the
COVID-19 vaccines last fall, they have to establish
the safety parameters. At what point, you know, at
what dosage do more than 50% of the people get sick? And during the course of that trial, they have to report the side effects. Now, there's 500 people in the study, and one person says, my ears are ringing, the manufacturer by law has to report, the chief investigator
has to report tinnitus as a side-effect, okay? If one person reports hearing loss, they have to report hearing
loss as a side effect. So, it's important to know how many people in the study reported that problem. Now, if 100% of the people, 500 people out of 500 report tinnitus, that's going to be a red flag, okay? One out of 500, not so much a red flag because it's only one out of 500. So we use the adverse reactions
or the side effects listing that appears on the drug
manufacturer's website or on certain commercial websites. And there are two that I use
regularly, I don't endorse them so I have no vested interest in them but it's rxlist.com and drugs.com.

These are great commercial websites, they get the information from the drug manufacturers
and from the FDA, but, you know, you'll see
information about tinnitus, which you'll also see an advertisement for buying land in New
Zealand at the same time. So, you know, again
it's a commercial site, but the reliability is quite good. And some of these websites
even have advisory boards. So, you have to take a look at where this information is coming from. So, it's important to remember that the FDA does have a handle
on prescription medications, and the manufacturer has
legal responsibility. I don't know if you're aware of this, but when the drug is approved by the FDA, that manufacturer has a 10-year window to keep all of the future
side effects that might occur, that didn't occur during
the clinical trials.

Because clinical trials you're dealing with a small population,
maybe two or 3,000 people, but now when you have 2 million people, using the drug now
after it's FDA approved, there may be some new side
effects that may emerge. So, the FDA has a 10-year
requirement for drug manufacturers to continually report back
on any new side effects that consumers report, and that's that MedWatch
program that I told you about. So, if that happens with an
over-the-counter prescription or an over-the-counter supplement, they need to know that, they need to know. – Yeah, that's pretty big
Bob because in my community, I'm interfacing one-on-one
with a lot of people with tinnitus who have
hit the end of the road. They've gone to different doctors, they're still left feeling like there's something they can do, but they're not sure how, those are a lot of
people that I work with.

There's a lot of sensitivity
for someone with tinnitus. Part of that comes from confusion and the medical system at large, not always directing
them on the safest path. There's oftentimes a
lot of anxiety, stress and sometimes depression
that can coincide with it as you know being an audiologist yourself. So, for someone who is trying
to be as safe as possible, 'cause the last thing they want, is for their tinnitus to get worse. But of course, most of
us throughout our lives, we end up using some pharmaceutical drugs to help manage certain health conditions. And for someone who is trying
to be as safe as possible, they look to see the
potential side effects of a certain drug.

And I get asked that question a lot, Dr. Ben, should I take this drug, 'cause it listed tinnitus
as a side effect? How would you respond to that? I mean, you just basically laid it out, but overall what is the
risk, if a few people out of a large sample size had
the side effect of tinnitus, is that something to be worried about or is that worth the risk? – I don't think it
should be worried about, I think that the patient, should have a really good relationship with their pharmacist.

Because the pharmacist
has the same database that you and I have access to
and consumers have access to. And the pharmacist
becomes your best friend, their computer systems, their counseling, their counseling skills like ours, are there to guide the patient. Now as audiologists, you
and I are going to make sure that there's no impairment in hearing, that could also be the
cause of the tinnitus. But, going back to what
you initially said, as far as the stress
and anxiety, you know, you have a cancer diagnosis, I mean, that's terribly stressful, I can only imagine what that's like. And if there's pre-existing tinnitus, it could exacerbate, make it worse and now it becomes more pronounced. I'm a firm believer in
professional counseling, I'm a firm believer in
mindfulness therapy, any type of relaxation
techniques that you can learn, even sometimes changing your diet, changing your sleep,
exercise, it's a process.

Ben, I think you know
this from your experience that the therapy or the help that you get outside of a pharmaceutical
or a supplement is a process. It's like oral rehabilitation
when you're working with persons with hearing loss or getting fitted with hearing
aids for the first time, it's a process and it can take months, and the patient has to be ready to make that commitment to the process. And I think once they make
that commitment to the process, again, like anything else, you know, you drop a big rock in the
water, there's the waves, and over a period of time,
those waves will settle down. And sometimes the waves are still there, but it's just not as pronounced
as it was in the beginning. Sometimes just letting people know that they don't have any
major pathological condition, you know, drops their blood pressure, a couple of points also.

But yeah, I'm a firm
believer in outside help, outside of just take the magic
pill and make it go away, and that doesn't exist right now. There's a research out there, okay? Looks very exciting, but
it's still too early. Just like what we're working
with COVID-19 and the vaccines, it's still too early to put
your finger on whether or not, a vaccine might be the
cause of your tinnitus. And I can talk about the Vaccine Adverse
Event Reporting System, we could talk about that
when we talk about COVID-19. So I'll follow your lead, on what you said about the
relaxation and the therapy. – Thank you so much
because that is important to recognize that there is some risk, there's some risk of potentially
having tinnitus spike by taking a certain medication. However, it can be really scary if you're trying to figure
it out all by yourself. So like you said, great advice,
reach out to pharmacists, have a good solid local
pharmacist on your team. Would you recommend
working with a pharmacist for managing the medications
over the primary care doctor? Because sometimes this can
be confusing to a consumer or someone who's trying
to figure this out.

So, who has more time,
who's going to counsel the person better about
the adverse drug effects? – With all due respect to the physicians, the pharmacist is, I think
more accessible, okay? Pharmacists don't close
between 12:00 and 1:30, okay? Seriously, and I don't say
that time in (indistinct) because accessibility and
most pharmacies have two or three pharmacists
working for them, you know, late at night and on the weekends, so there's always accessibility. First of all I'd get a good relationship with the pharmacist and the
pharmacist has a relationship with that primary care
referring physician.

The pharmacist has a computer
program that won't see whether or not there's any
drug-drug interactions, or any drug or dietary
supplement interactions that may be causing the ringing
or any type of ear noise that you have whether it's
one ear or both ears, okay? Now again, to the people that
are watching this right now, keep in mind that, you know, The worst tinnitus I had was
four days after a concert. I had lousy seats with this concert, so I didn't wear my hearing protection. I was like, in like the 50th row way in the back in this outdoor arena.

It was a Saturday night and my ringing didn't
stop until Wednesday. And I can only imagine
what it must be like to have it all day all night. So, I can relate, but mine went away, I don't have it all the time. And I know, and I appreciate it, understand as best I can the frustration, when my patients are in front of me and they say, doc, listen, and they bring their ear
to my ear, (chuckling) You know, they want me hear, the tinnitus is a one way event. The sound only goes up, it
doesn't really come out. So, I just want people that
are watching this to know that the audiology profession,
we understand this, we understand this.

And you know, it frustrates us, it ties our hands up too when, you know, we can only go so far, but
we want you in the process. And that the process means
a better relationship with the pharmacist to
better understand the drugs from a pharmaceutical side, that's fine. When it comes to any hearing impairment or anything related to
dietary supplements, your audiologist is just
going to come back in here. When it comes to counseling, okay? There's nothing wrong with reaching out and asking a counselor, do you counsel patients for
anxiety Who have tinnitus? And some of them will say, no, some of them will say, yes, okay? And then you have to feel
comfortable in that first session or that second session with them to say, yeah, okay, that's fine. And sometimes just
knowing that there's help, I think can really lessen the tinnitus because it's got to reduce
the vasoconstriction, okay? It's going to bring more oxygen up, this is where exercise
comes into play here, but some people don't, they
can't get out because of COVID and they can't get to a gym.

So, maybe there's something
they could do in-house with some of the guidance
from an exercise physiologist for that matter. So, there are ways in
which you can manage it, it's just a matter of just
like, where do you go, okay? And I'm hoping that this conversation that we're having today Ben,
is going to help people to say, well okay, you know, I
never thought of that, all right, I'm going to try that. But if you try don't
make it a one-shot deal. I mean again, it's like
anything else you've got to, it's the process of staying with it, okay? And keeping your audiologist
informed of your tinnitus, talking to the pharmacist, I mean, that's what they're there for.

Pharmacists are trained like audiologists, to do the same type of counseling work, to guide you through the maze. That's what we went to school for, our job now is to get
you through this maze. So just ask the questions
and now you know, who you can ask the questions to. I hope that that helps. – I really appreciate that, it does help, it's a team collaborative effort. You had mentioned
earlier the COVID vaccine as well as COVID-19 itself. I've had a few patients come to me, who developed a tinnitus
seemingly out of nowhere around the time that they got COVID-19, and those are always hard to parse out because it's multifactorial, there's the COVID virus itself, there's the stress that goes with it and then there's something physiological that could be happening as well. And then we have the COVID vaccine and how tinnitus could be, and I want to ask you on the data on this, on whether tinnitus is a side effect of the COVID vaccine and
does that vary by a vaccine? So take the floor on this, I know you've been doing
some research on this, why don't you go ahead and
update us on what's going on? – First of all, when the virus
gets in the system, okay? When it gets in the system, and if it gets into the auditory system, if it gets into the inner
ear, into the cochlea, and that seems to really
be the point of entry, through the blood supply
going into the inner ear, very microscopic blood supply.

The first thing that's going to
go away is your hearing, okay? Not go away completely but the first thing that will be affected, are the hair cells that
transmit sound to the brain. And when they become effected by the virus because of the change in the blood supply or the viruses attacking the system, the hearing loss is going to
be, number one predominant, because you're just going to have trouble, understanding what people are saying. It's not a (indistinct) issue, it's more of a clarity issue. Number two is that we know
that tinnitus is a side effect of the hearing loss. And we also know that you
can function very well with hearing loss without
wearing hearing aids, depending on the degree of the loss. So in the early stages, you might not see a major
communication problem, but the tinnitus might
be presenting symptoms. So, what would happen is that, you would complain about the tinnitus. So, we'll point the finger
at the tinnitus as the cause as a result of the vaccine
or result of the virus.

But it's probably more
hearing loss related than the tinnitus of directly
the result of the virus. So the virus is causing hearing loss and the tinnitus is a
side effect of that, okay? That's my opinion as far as the etiology where it's coming from, okay? As far as the vaccines
are concerned, you know, before we had this vaccine developed in less than a year, the record, okay? For the fastest, the fastest path, from proof of concept, clinical
trials, the FDA approval, the fastest on record is four years, okay? We did this in nine months, so you take a look in less than 25%, there's still things
that we just don't know, there's still things
that will just emerge.

The manufacturers give
you a number to call, you call them if you have any
type of adverse reactions. Usually the adverse reactions are pain at the site of the
injection, fatigue, headache. Well, that's good news, I mean, it means the vaccine is working, okay? But when there's tinnitus that shows up, and usually it will show
up from my experience and the emails I'm getting from my website and what I'm hearing from you,
Ben and from my colleagues, usually two or three days later, okay? And sometimes it's pretty loud, everybody's reaction is
going to be different. And again there it's
added stress and anxiety, so there's more oil on the fire.

But the U.S. Department of
Health and Human Services, HHS, has established a Vaccine
Adverse Event Reporting System, V A E R S, Vaccine Adverse
Event Reporting System, and it's vaers.org, okay? Or you can go to the Department
of Health and Human Services on the website and this type in, Vaccine Adverse Event Reporting System. And then they're now
pulling in information about people's experiences
with any of the vaccines. Whether it's the new J&J
or the Moderna, Pfizer or AstraZeneca which coming
down the pipe in the UK. So they're collecting all this data and right now it's very early, we just don't have
access to these numbers. So, we're letting our
patients know that, report it. Don't just say, oh, my
ringing in the ears, I got it from the
vaccine, report it, okay? It's going somewhere.

And if you go to the Vaccine
Adverse Event Reporting System for the Department of
Health and Human Services, it's going into a database. Now I've already been in touch with them, and I'm waiting for a
response to my inquiry as far as that particular data for tinnitus and hearing
loss and balance problems. So, ladies and gentlemen,
people who are watching this, we don't know either, it's still early on. So we understand, okay, we feel for you our empathy is there, we're concerned, but right now, it's still new.

Remember, the mumps and
measles rubella, the MMR back, took four years and that was the fastest before COVID-19, these new vaccines, that was the fastest beginning to end from proof of concept to FDA approval. That was four years, that was the record. We just said the record now
with less than 12 months. So, it's still early, okay? So just work with the symptom
and work with what we know about tinnitus that we
knew before COVID-19, and that basically is just stay in touch with your audiologist, stay in touch with your pharmacist.

Remember that it's a symptom, that something's causing that to occur. Let's rule out the organic stuff, okay? And then we go up to the non-organic and non-organic would be
the stress and anxiety. The organic would be whether
it's slacks in the ear or some fluid infection or
just a change in hearing just because of a couple more birthdays, okay? So, I hope that helps and
kind of focus our viewers on the whole vaccine situation or what you can do in the interim, 'cause it's going to add
to the body of knowledge and the researcher, you
are part of the solution to help other people maybe a year or two down the road from now. So please, the Vaccine Adverse
Event Reporting System, and of course the vaccine manufacturer, just let them know what's
going on, call them up. – Thank you for that Bob, yeah, I'll do my best to help
relay that information when you get that data to
my audience here as well. – It takes a couple more months but yeah, we'll come back
in a couple of months, okay? We'll do this again,
I'll give you an update.

– Sounds good and as with
anything health-related, there's sometimes some inherent risk in taking on a treatment. So, one has to ask, what is the upside of
getting the COVID vaccine, well, quite obviously not dying from COVID and not passing it onto
your family and community? If there is a chance that
your tinnitus could spike or change that may be a risk right now, but it's unclear, it's
too early to really say that tinnitus is a consistent side effect, would you agree with that? – There's no question about it.

It's only two months since we
had the vaccines in the arms, and I'm just hoping
that all of these people that have their first shots, that are experiencing this
and it's my understanding, I haven't had my first shot yet, I'm still on a wait list over here. We have a lot of people here in New Jersey and there's a lot more
people that are on the ladder that are in front of me
that have a higher risk, so I'm just laying low right now. But, I just hope that, you know, I know that the manufacturers
are giving you information to call the number if you
experience any side effects. So, the manufacturers are still, so this is an emergency
user authorization, which are also part of the clinical trial, technically speaking, okay? So we have millions of people now and if they find out that 100,000 people, out of 5 million are
getting tinnitus, okay? They're not going to say that
tinnitus is a major problem, but to those 100,000 people,
it's a major problem, that's 200,000 ears that
are not working right.

So, maybe you've to keep
a record or keep a log or some type of diary of sorts
of when the ringing occurs. Is it louder in the daytime,
is it louder at night when the room is quieter,
have you had a hearing test? We know that hearing loss can be part of the COVID diagnosis and
it can happen later on.

It doesn't happen immediately, we call that, the phrase
that they're using now Ben, is called long-haulers, okay? Persons that have the diagnosis, whether they were hospitalized or not, but three or four months later, now their ears are ringing or
they develop balance problems or this other gastroenterological
problem's going on. So, years ago we used
to call it late onset. Now with COVID, they're
calling it long-haulers. There's about 10 different
diagnosis for the same COVID-19. You know, from COVID-19
syndrome, it goes long-haulers. So, the effects of the virus
are still with people even after they've cleared and
become, (muffled speaking) symptoms or they're asymptomatic.

So, these patients should stay in touch with their
primary care physicians, or their treating doctor
or their pharmacist, because we're still
learning a lot about this. This week I think is the
one-year anniversary. There's still a lot more
to go to learn about this. So, we ask everybody's patients, we've all been patient for the past year, but from the medical
issues and the concerns, the tinnitus, and so on, the hearing loss, we're still in the infant
stages of understanding this. So, just keep your audiologist informed, Keep the vaccine manufacturer informed, the Vaccine Adverse
Event Reporting System, keep them informed. Even if your tinnitus is tolerable now but you get your second
shot and it spikes, you got to let them
know 'cause we're trying to see if there's some
type of common denominator or some type of pattern here that we can learn from this, you know, as other viruses find their
way out into the atmosphere. – Yeah, thank you for explaining Bob. – It's one big experiment. – Yeah, and another topic
here that comes up a lot in this kinds of discussion
not related to COVID but per prescription
medications and tinnitus, is antidepressant
anti-anxiety medications.

I'm going to make a
separate dedicated video, maybe we can or I can reach
out to a different doctor or a pharmacist themselves or
a physician to go really deep into that subject 'cause
it's rather complex. But I just wanted to bring that in, that is a common conversation
for tinnitus and medications, are those antidepressant
anti-anxiety meds and how the meds themselves are
treating depression and anxiety. So, when depression and
anxiety are managed, sometimes tinnitus can reduce in volume. What happens when you reduce
or taper off your meds, the tinnitus increases in volume. I work with a lot of people
who are balancing that, and there's some interesting topics of, can someone still have
healthy neuroplasticity to go through proper training
and auditory retraining and tinnitus retraining therapy? Is therapy effective when I'm on such high
anti-anxiety antidepressant meds? This is a team effort, it's
a collaborative effort.

As an audiologist, I try
to counsel effectively about how there is that
link between stress, depression, anxiety and tinnitus. And we're not trying to go cold turkey, taking off the antidepressant meds in a short period of time,
it's a slow gradual process. And during that process,
we want to build up the internal resources
for health and wellness, so that at some point if you
choose to, maybe the individual or the patient doesn't
have to rely on those drugs to live well, to live
healthy, even with tinnitus. So that's a complex issue, do you have anything to add to this? – I think the point, what
you're saying is spot on. I think the viewers are seeing right now about what you and I
are talking about here.

Is that this whole thing
with tinnitus and anxiety and the medications, reaching
a goal there's a process. That it's not a medication
magic pill situation. And I think a lot of
people understand that, but a lot of people might
not, that this is a process. You know, the prescription is
coming from your primary care or the psychologist, a
psychiatrist i should say. And again, it's the
relationship that you have, it's a process, it can
take several months, it can take several years, it's a process.

So, what's causing the
anxiety and the depression? The magic pill is there to kind of, get the rough edges smoothed out, and the tinnitus becomes a side effect of either the medication or the anxiety. Well, which one is it? Sometimes it's difficult to really put your finger on which one. I mean, we would like to say, it's this, it's this, it's this, but sometimes we just can't. And that's got to be frustrating, and there goes to tinnitus,
so it's a cycle here. So, I think the persons that
are taking antidepressants, and have tinnitus because
of the antidepressants, stay with your counselor,
stay with the psychiatrist, stay with the person who's ordering it. It's not just get a script and it's going to go away
and get better and, you know, no, it's not that at all, it's a process. And if they recognize the process and they work and blend into the process, then I think the prognosis
for success is much better. – Thank you, Bob, thank you for that. And too, it's been a
pleasure to have you so far.

To wrap it up we're going to talk about the newest research developments. Recently released two videos
on my YouTube channel, which has gained a lot of popularity, talking about frequency, therapeutics, FX-322 and Otonomy OTO-313, and how those are two new solutions that are being researched
in clinical trials, the level of the inner ear,
the cochlea, the hearing organ, to try to change the structure in an effort to improve hearing outcomes and potentially improve tinnitus. What is your take on these kinds of drugs? You've been following them
closely, that's correct? – It's exciting, it's very exciting that these companies are doing this. From what I'm reading, a lot
of these clinical trials, require that the medication
that they're trying is a gel, that is injected through the
eardrum into the middle ear, and it's absorbed into the cochlea through an area called the round window.

And so, it is an invasive technique, it's not something that's oral. And you know, what I've
seen is that those companies that are moving along in their research, are the ones that are using
invasive injectable procedures to get the drug into the system. So, you can find out more
from these manufacturers. You could also go to a
website called clinicaltrials, all one word, clinicaltrials.gov, okay? And you can type in, tinnitus, and on the left-hand side you
can set the different criteria or other words that you would want, tinnitus COVID-19,
tinnitus antidepressants. And then the database will fire up in a matter of half a second. All of the clinical
trails that are occurring, with your criteria in the United
States or around the world. So if you want to participate or find out who's doing (indistinct) or where it's doing (indistinct)
to get more information, that's a great website to start with.

It's a government website,
clinicaltrials.gov, okay? Just type in your particular issues and then just read the list
of who's doing what and where, and maybe there's something nearby and maybe you might want to participate. With COVID-19, there are 26 countries that are doing COVID-19
vaccine research right now. And there's something
like 480 test centers around the world that
are looking for people to participate in clinical trials. So if you want to
participate, ready to go. – So Bob, quick question follow up here on those different drugs solutions that are being researched. Being scientists who have some message for the public, right? It's really valuable,
it's really important for us to try to be as transparent about the validity of
such research, right? And with prescription drugs,
with these kinds of drugs that are tested rigorously, it's in a double-blind control manner, and in that sense, it's great
because you can't fake it.

But at what point does the
research reach the tipping point in terms of the population
size, the group, the number of participants, specifically frequency therapeutics, the autonomy group, right? At what point might it reach
a tipping point of us saying, okay, this is probably going to work. – (hums) The chief medical
doctor investigator, collects all this data from
the different research sites that are signed on to be co-investigators.

And they will get to a
point where they will start to see their data start to
increase (indistinct) a plateau. And then when they get
to that plateau point for efficacy and safety, they turn that information
over to the FDA. The FDA group-analyzes that and they either give
their blessing and say, okay, you can go to the next
level and try more people or they can say, no this isn't working, or some of the manufacturers just pull it. They just pull the drug and
say, this is not working and, you know, we thought it would work. It's called the proof of
concept, way back early on. And then they try and prove it, okay? From beginning to end, okay? Where from proof of
concept to FDA approval at a best case situation, it
costs the drug manufacturer about 1.3 billion with
a B, $1.3 billion, okay? To bring one drug to market.

I saw some estimations
that the vaccine costs, that Moderna, Pfizer what they spend, anywhere between 30 and
$60 billion for this, okay? It's huge money that's involved because there's so people involved. And usually the volunteers are paid, they can be given two or
$3,000 to participate. So, you know, there's a
cost that's involved here and you see ads sometimes in the papers to get involved with a clinical trial.

So, the manufacturer and the medical team from that manufacturer, there
are specific FDA guidelines. On average it can take
maybe eight to 10 years for a pharmaceutical to
come to FDA approval, okay? And then for a vaccine,
again the shortest time on record is eight years, now that's been surpassed
by the COVID vaccines. It's a process, the FDA says, got to make sure that if
you're going to take this pill, we're going to get this shot. That, you know, you have to know that we have all of the
possible side effects that could occur, and the only way in which you get all of
the possible side effects, is to have thousands of people
involved in the research. So, I really want to take my hat off to all of the people who volunteered, to be part of the COVID vaccine research over the last six months
or last nine months.

There are people who volunteer
to take this unknown vaccine, to, you know, to help other people. And this is remarkable that
people will actually do that. And so we have those people to thank. So the researchers we thank, but also the people who
stepped up and said, I want to help my fellow person, my fellow human, my fellow man, and I'll be part of a clinical trial. So, clinicaltrials.gov, okay? It's very easy to navigate through and you can find out what's going on in your area on not just COVID, but any medical problem at
all, even dietary supplements. – Thank you so much, Bob. Guys we are here with Dr. Bob DiSogra, who is a doctor of
audiology in New Jersey. Bob, where can our audience find you to learn more if they want to either, meet you in person in your local area, at your clinic or find you online with your research into pharmacology? – Easiest thing to do would be to get me online at the website, okay? If you don't mind, which
is drbobdisogra.com, D R B O B, and the last name, D I S as in Sam, O G R A,
DiSogra, drbobdisogra.com.

And there's all sorts
of information in there, even some communication strategies to help you get the most
effective use out of hearing aids, even if you're not wearing hearing aids. So, across the top
there are different tabs and there's one (indistinct) MORE, and then you pull down that
menu and scroll on down. You can see the diabetes
medication side effects, you could see the
communication strategies, and you can take a look at some of the COVID 19 publications
that have been out in the last year to help
people to understand, what we're trying to do here to help out.

So we're all part of the process, okay? It is a process and we just
asked you to lengthen your fuse, and, you know, just your
primary care, psychiatrists, pharmacists, audiologists,
even a social worker 'cause there are obviously
the stress on the family, you know, can also be problematic. So, you have options out
there, exercise your options. And they're all good options, and everybody wins at that point because, we're going to be happy
that you're better, and you're going to be
happy that you're better, and then the trickle down to the family and your friends, it's priceless. But then, thank you for having
me, I really appreciate that.

Good luck to the audience, okay? And hang in there, we're
all in this together. – Thank you so much, Dr. DiSogra, this is episode 16 of the Pure
Tinnitus and Hearing Podcast, check out our other episodes to hear from other professionals and be well everyone, thanks, goodbye. (upbeat music).

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