Scared About Covid-19 Vaccine Side-Effects on Tinnitus? – Robert DiSogra, AuD – #16

COVID-19 side effect to tinnitus

Ben Thompson, AuD.

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 the 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.

Robert DiSogra, AuD.

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.

Dr. Ben Thompson and Dr. Robert DiSogra discussed how anti-anxiety medication can be used for tinnitus.

Ben Thompson, AuD.

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 is a picture of an advertisement and saying, hey, has anyone tried this, does this work? You are an expert in prescription drugs, you’re an expert in medications and classifying their validity on tinnitus as well as hearing loss. So, give us a quick overview on, what are the takeaway points you want someone to know about over-the-counter medications and herbal supplements for tinnitus?

Robert DiSogra, AuD.

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.

Ben Thompson, AuD.

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 many 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?

Robert DiSogra, AuD.

The 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

Ben Thompson, AuD.

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?

Robert DiSogra, AuD.

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, these 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.

Ben Thompson, AuD.

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?

Robert DiSogra, AuD.

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 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.

Ben Thompson, AuD.

Thank you so much because it is important to recognize that there is some risk, there’s some risk of potentially having a 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?

Robert DiSogra, AuD.

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 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, 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.

Ben Thompson, AuD.

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 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 varies by 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?

Robert DiSogra, AuD.

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 affected 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 an issue, it’s more of a clarity issue.

Number two is that we know that tinnitus is a side effect of 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.

Ben Thompson, AuD.

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.

Robert DiSogra, AuD.

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.

Ben Thompson, AuD.

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?

Robert DiSogra, AuD.

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 waitlist 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, 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, keeps 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.

Ben Thompson. AuD.

Yeah, thank you for explaining Bob.

Robert DiSogra, AuD.

It’s one big experiment.

Ben Thompson, AuD.

Yeah, and another topic here that comes up a lot in this kind 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 are 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 a 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?

Robert DiSogra, AuD.

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.

Ben Thompson, AuD.

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?

Robert DiSogra, AuD.

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 clinical trials, 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 trials 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 or where it’s doing 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.

Ben Thompson, AuD.

So Bob, quick question follow up here on those different drug 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.

Robert DiSogra, AuD.

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 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? Wherefrom 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.

Ben Thompson, AuD.

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?

Robert Disogra, AuD.

The 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 are 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 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 is 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.

Ben Thompson, AuD.

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.

Dr. Ben Thompson, Au.D.

Dr. Ben Thompson, Au.D.

Dr. Ben Thompson is an audiologist in California and founder of Pure Tinnitus. Dr. Thompson has a comprehensive knowledge of tinnitus management. He completed his residency at University of California at San Francisco (UCSF) and is a past board member of the California Academy of Audiology. Via telehealth, Dr. Thompson provides services to patients with hearing loss and tinnitus.

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