Tinnitus, Tinnitus Cures, and OTC Tinnitus Remedies: Interview with Robert M. DiSogra, AuD
Douglas L. Beck, AuD, spoke with Dr. DiSogra about all things tinnitus, including the importance of an evaluation by a licensed health-care professional and patients’ various treatment options.
Academy: Hi, Bob. Great to speak with you!
DiSogra: Hi, Doug. Thanks. Good to speak with you, too.
Academy: Bob, I saw that you’ll be on the faculty for the 22nd Annual Tinnitus Conference held at the University of Iowa this summer, addressing the efficacy and safety of OTC tinnitus relief products currently available over the counter (OTC)?
DiSogra: Yes, that’s right. It was an honor to be asked to join the meeting faculty and to present a session at this excellent meeting.
DiSogra: Exactly. I should mention that the 2014 Guest of Honor will be Anne-Mette Mohr. Doug as you know, Anne-Mette Mohr is the author of Patient-Centered Tinnitus Therapy—Partnering with the Tinnitus Patient in Rehabilitation.
Academy: She’s a clinical psychologist and existential psychotherapist, and she is the director of the House of Hearing Interdisciplinary Health Clinic in Copenhagen, Denmark. I should also note the meeting will feature a series of special presentations including topics such as counseling and sound therapy, tinnitus alleviation therapy, animal models of tinnitus, medications and dietary supplements, stress reduction and almost a dozen industry representatives, as well as academics and more.
DiSogra: You’ve done your homework! Yes, the conference provides a wonderful opportunity to get up to speed on issues in tinnitus management in 2014.
Academy: And it looks like your presentation will focus on over-the-counter (OTC) tinnitus relief products?
DiSogra: Yes, this is something I have been interested in for quite some time.
Academy: Can you give us a little bit of a “heads up” without giving away the whole presentation? And as there are some 50 million people in the United States with tinnitus, let’s start with a basic definition. What is an OTC tinnitus relief product?
DiSogra: Any commercially available product that is produced and marketed to the tinnitus patient that claims to provide relief, or serve as a cure for their tinnitus.
Academy: And of course, there’s a wide open and vast quantity of unsubstantiated OTC tinnitus relief products and claims out there. In fact, I just searched on the Internet for the term tinnitus relief products and I learned there were some 235,000 clickable links. Which means (to me) there are about 235,000 product links, some of which are clearly dubious in nature!
DiSogra: It seems like every product is “linked” somehow when tinnitus is searched. And as far as what you might find on the shelves of your pharmacy or grocery store, there are some 50 products that I’ve seen. The bottom line is these companies that market and advertise OTC tinnitus relief products have virtually no FDA oversight or approval and so as you would expect, there’s very limited science or research on their ingredients or products used in OTC products to treat or cure tinnitus. I would like to point out that of the 50 products, none are FDA approved for tinnitus relief.
Academy: And further, by saying “very limited science or research,” we should explain that physicians, audiologists, and other health care providers know that to make a serious claim, one must engage a control and an experimental group. And frankly, simple testimonials from Joe Smith of YourTown, USA, speaking about his tinnitus relief after increasing his zinc consumption to near toxic levels is just crazy, dangerous and should not be taken seriously. Nonetheless, tell me more about the 50 products you’ve looked at?
DiSogra: These products come in tablets, capsules, sprays, earplugs that provide transdermal introduction of some medicine into the blood system, vibratory devices and more. As I mentioned above, none of them are FDA approved for tinnitus relief. Some have just three ingredients and some have over 35 ingredients and the claims and marketing slicks look very professional and convincing. But clearly, the scientific basis is lacking or missing entirely. In fact, if one were to visit the NIDCD Web site they state pretty clearly that tinnitus does not have a cure, but treatments that help many people cope better with the condition are available.
They address counseling, hearing aids, ear level and table-top maskers, acoustic neural stimulators drugs and cochlear implants, and then they state “Antidepressants and anti-anxiety drugs might be prescribed by your doctor to improve your mood and help you sleep. Other medications may be available at drugstores and on the Internet as an alternative remedy for tinnitus, but none of these preparations has been proved effective in clinical trials.”
Academy: Like melatonin for tinnitus?
DiSogra: Yes. Surprisingly, there’s a considerable amount of research on melatonin, and you’ll see that in many of these products, but the “cause-and-effect” of tinnitus relief from melatonin is not there. That is, because melatonin may help many people sleep, it may allow some tinnitus sufferers to sleep, too, and that’s great, but that’s not actually tinnitus relief, that’s sleep!
Academy: And it really doesn’t interact with tinnitus at all…it’s just that when you’re asleep, you don’t notice your tinnitus. I suspect we could make the same claim for products that relieve stress, anxiety and tension, too, in that many tinnitus patients have stress, anxiety and tension, and if you relieve those signs and symptoms, their quality of life improves, but not because you cured their tinnitus.
DiSogra: Some of these products may have reasonable applications, and some may provide some secondary tinnitus relief, but in general, that’s not the way they’re marketed or sold, and so we get back to “let the buyer beware!”
Academy: So tell me, Bob, just how many ingredients did you identify in these 50 products and what percentage of these ingredients actually had published research?
DiSogra: Interestingly, of all the 228 combined ingredients which I identified in these 50 products, melatonin had the most published research - seven articles! To answer your question, approximately 10 percent of the ingredients had tinnitus-related research—however, some of the data were more than 30 years old, with just a handful of data in the last five years. So the research is still lacking with supplements, herbals and/or traditional Chinese medicine.
Academy: And please explain to me the link and labeling associated with tinnitus and the Dietary Supplement, Health and Education Act of 1994 (DSHEA)?
DiSogra: Great question…the federal government (in 1994) passed the DSHEA stating the supplement manufacturers were allowed to say something like “This particular product can relieve your tinnitus” and this was allowed for the purpose of “influencing public opinion”—whatever that means!
Academy: All of which is quite insane…so you’re telling me the FDA and the FTC allows DSHEA to clearly and intentionally mislead or otherwise misinform consumers?
DiSogra: It’s not a mislead per se. It’s a loophole on the same lines as defining a personal sound amplifying product (PSAP) and a hearing aid. It’s how it is marketed. As long as the manufacturer also states “these statements have not been evaluated by the FDA, this product is not intended to diagnose, treat, cure or prevent any disease…” then yes, they are allowed to say things like “This product will cure your tinnitus.”
Academy: Again, clearly insanity has won. And to be clear, I have to say as an audiologist, I am not aware of any universal, pharmacologic solution to tinnitus…am I correct?
DiSogra: Yes, you are correct. Of course, one major issue is tinnitus may be caused by a myriad of etiologies ranging from trauma, acoustic trauma, hearing loss, many common medications, ear disease, brain issues, neural issues, perceptual integration and so much more. So there’s not going to be one thing that works on all of them or even most of them. It’s just not a simple problem and any OTC or “universal” solution should be viewed skeptically.
Academy: Many of our colleagues make the analogy that tinnitus is like pain. It’s invisible, no two people describe or experience it the same, it can be incapacitating, and each person requires a professionally driven and personal solution.
DiSogra: You know the drill. Diagnosis first, management/treatment second. Of course sometimes (in rare cases) tinnitus can be a sign or symptom of something dangerous occurring in the ear or brain and so it must always be professionally evaluated and diagnosed prior to treating it!
Academy: Agreed. I recommend the first step is a visit to the general practitioner or the audiologist for an otoscopic exam and case history. If anything appears suspicious, or if the problem appears to be a medical or surgical issue, appropriate management and/or a referral is made. The good news is that probably some 95 to 97 percent of all tinnitus does not have a dangerous medical etiology, and I believe some 90 percent of all tinnitus can be managed successfully by the audiologist through counseling and the provision of sound generating devices. I should hasten to note, the most successful sound generating device of all times, with the widest applicability is the modern, extended bandwidth hearing aid.
DiSogra: I agree, Doug. The first step for the tinnitus patient is an evaluation by a licensed health-care professional, and for tinnitus sufferers, who are properly evaluated, there are quite a few treatment options and as you said, Doug, the vast majority of tinnitus sufferers can be helped via professional medical and audiologic management. As long as the patient and the audiologist continue to work towards the goal, it’ll happen 9 out of 10 times.
Academy: Thanks, Bob, for your time and expertise.
DiSogra: My pleasure, Doug. Thanks for your interest and publications on this same topic.