Buzz Kill: Self-Dissolving Tinnitus Treatment Gives New Hope

Karl

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Dec 23, 2011
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HEAR THAT?: Draper Laboratory in Cambridge, Mass., is fleshing out a concept for a small delivery device that can provide relief to tinnitus sufferers. The device would be inserted near the membrane-covered window separating the middle ear from the inner ear and release medication into the cochlea.
Loud, concussive explosions on the battlefield may last only a few seconds, but many soldiers returning from combat in the Middle East are experiencing lingering symptoms that cause them to perceive sounds even when it is quiet. Doctors can do little to treat the problem—typically described as a ringing in the ears—because they lack an effective way of delivering medication to the inner ear. That could change in a few years, in the form of an implantable polymer-based microscale drug-release system that delivers medicine to the inner ear.

Called tinnitus, the condition afflicts at least one in every 10 American adults and is the most common disability among Afghanistan and Iraq war veterans, according to the U.S. Department of Veterans Affairs (VA). Up to 40 percent of all veterans may be suffering from tinnitus, and the VA spends about $1 billion annually on disability payments for tinnitus, according to a study published last year in Nature. (Scientific American is part of Nature Publishing Group.)

To address the problem, the U.S. Department of Defense has commissioned Draper Laboratory in Cambridge, Mass., to spend the next year fleshing out a concept for a small delivery device inserted near the membrane-covered window—no more than three millimeters in diameter—separating the middle ear from the inner ear. Once at the membrane the device (essentially a polymer capsule, although Draper is not developing any of medicines that might be placed inside) would release a drug into the cochlea, the tubular organ residing in the inner ear that enables us to hear. The plan is to embed wireless communications into the capsule so that a patient or doctor can control the dosage. After the capsule finishes delivering its supply of drugs, it would dissolve.

Although Draper's project is still in the very early stages and years away from any clinical testing, it holds more promise than many of today's most common approaches to tinnitus treatment, which include deep breathing, using background noise to drown out the ringing or simply learning to ignore the bothersome sound. Steroids injected into the eardrum have shown some promise in helping patients with certain hearing and balance disorders, but the ear begins eliminating these drugs through the eustachian tube (a passageway in the middle ear that acts as a pressure equalizer) as soon as the patient talks, swallows or even sits up. As a result, the patient must endure several injections into their ear and remain immobilized for a time after each injection to get any relief from the malady.

"By and large there aren't that many good ways to treat tinnitus," says Lloyd Minor, provost and senior vice president for academic affairs at Johns Hopkins University. Draper's work "is potentially a novel way of delivering drugs to treat tinnitus. In general, we don't have the types of drug-delivery systems that we would like to get medication into the inner ear."
NeuroSystec Corp. is developing a neuro-active agent designed to calm the hyperactive nerves responsible for cochlear tinnitus. The Valencia, Calif., biotech start-up has licensed an osmotic pump from Durect Corp. in Cupertino, Calif., a company working on a number of drug delivery mechanisms for various parts of the body, including the inner ear.

Other advanced approaches of addressing tinnitus have been in the works for years, but most are still not ready for the market. Otonomy, Inc., in San Diego is testing a sustained release dexamethasone (a type of steroid) gel that would be injected into the middle ear, where it would stay in place, dissolving slowly and delivering treatments for hearing and balance disorders. MicroTransponder, a medical device company spun out from the University of Texas at Dallas in 2007, is looking to broaden the use of its implanted wired neuro-stimulation system for treating epilepsy to likewise help tinnitus patients.

The neuro-stimulation approach shows greater promise than those based on delivering medication to the inner ear at this time, says Michael McKenna, an otologist and neurologist at Massachusetts Eye and Ear in Boston. Targeted drug therapy is of questionable benefit because tinnitus comes from a variety of causes—including age-related hearing loss, traumatic ear injuries or circulatory system disorders—and has varying degrees of severity, he adds.

Perhaps some combination of all these efforts will end up delivering the relief that tinnitus sufferers seek. "Nothing really has been a panacea, so there is the need for further technological development," Minor says. If Draper's technology "works in the way they're hoping it will work, it will potentially be a big advance for the field."
 
Ah yes... I knew I saw this a while ago. Here is the link I found. In fact, I looked at this last week and didn't post cause it was older news that I had seen. http://www.scientificamerican.com/article.cfm?id=tinnitus-treatment I actually came across it again when I researched dexamethasone (a type of steroid) as noted in your article. Dated in 2012.

I was looking for a pill that was used in the thread : Cortisol Suppression and Hearing Thresholds in Tinnitus After Low-Dose Dexamethasone Challenge

Maybe we are on to something with all this news centered on dexamethasone!! ;)
 
So they came up with a delivery method before the actual delivery.:cautious:
Sort of reminds me when I wanted a bike so bad I bought a nice leather motorcycle jacket...
Still don't have a bike yet.
 
Somebody emailed this article to me this week. I no longer subscribe to Scientific American (;) ), but as Calin pointed out, this article is a year old. That's good news for us, because that means Draper Labs has been working for at least year on this. I would really like to know about the present status of this effort. (I wonder why Microtransponder is even mentioned?)

Recently another poster on this website, Victor Salvatore, wrote that a military doctor said this treatment should be available in the next 2-3 years. With 40% of veterans having tinnitus, political pressure is on U.S. Congress to find a fix. Cure for tinnitus = Votes.

The Pentagon has the money to make this a serious effort - unlike little 'ol ATA, which seems sort of anemic in resources. This may be a BIG stealth project, who knows?

My only critism: They are making the assumption that tinnitus is caused by nerves inside the ear drum. That is a big assumption on their part. I'm of the opinion that tinntus may be caused by the efferent nerves connected to the back side of the cochlea. Getting medicine to those nerves would seem a lot more difficult.

Most of us who have taken benzos like clonezam, Xanax, can verify that these drugs can reduce tinnitus. The problem is, when you take a benzo, your whole brain gets it. If something like a benzo, or better, can be administered locally to the nerve that is causing tinnitus, that approach makes a lot of sense.
 
"Otonomy is advancing both OTO-104 and OTO-201 into
late-stage clinical trials. Additional product candidates are expected to target tinnitus and chronic
forms of hearing loss."

Their results are encouraging for Meniere, patients also had tinnitus reduction using their compound on phase 2
 
"Otonomy is advancing both OTO-104 and OTO-201 into
late-stage clinical trials. Additional product candidates are expected to target tinnitus and chronic
forms of hearing loss."

Their results are encouraging for Meniere, patients also had tinnitus reduction using their compound on phase 2

While that is cool, it seems like that is just saying that specific compounds for tinnitus and hearing loss are still in pre-clinical stages. :(
 
Here is specific information on the Otonomy drugs:

OTO-104 is a sustained-release formulation of the steroid dexamethasone. Based on the current use of oral and IT steroids in the treatment of hearing and balance disorders, the target market for OTO-104 is more than one million patients per year in the U.S. alone. A Phase 1b study of OTO-104 has been completed in patients with Ménière's disease. Lambert et al3 reported OTO-104 to be safe and well-tolerated. Furthermore, patients treated with OTO-104 experienced clinically meaningful reductions in vertigo frequency and improvements in tinnitus as compared to placebo. Further studies are being planned.

OTO-201 is a sustained-release formulation of the antibiotic ciprofloxacin designed to treat various middle ear conditions including recurrent or persistent otitis media. A Phase 1b clinical trial has been completed in pediatric patients undergoing tympanostomy tube placement surgery. Study results showed that OTO-201 reduced the risk of treatment failure, as measured by the occurrence of post-operative otorrhea (drainage) or use of rescue antibiotics, by more than 60% versus control (p<0.05). Additional clinical trials are being planned.

Source: http://www.otonomy.com/about_pipeline.html
 
@Leah Thanks for the post! There's lots of great information regarding OTO-104 along with a potential timeline for clinical trials. It looks like Otonomy may be in a Phase IIb trial for OTO-104 by the end of this year. Though this drug is designed for people with Ménière's disease, Otonomy is also interested in tinnitus specific treatments. I'm sure the favorable results from OTO-104 will affect future tinnitus research. Otonomy believes the intratympanic injection market for tinnitus and otic disorders has the potential to be huge--and hugely successful, we can only hope!

And, of course, OTO-104 is great news for people with Ménière's disease on this board! I also know a girl with the disease and it can be quite devastating.
 
I've had a couple of experiences when I feel that my brain "forgot" about my T for a short period, it's been either when I need to focus fast and firmly, like when I'm scared cause a car almost hit me and I need to take action to move away. Or if a positive situation very suddenly and unexpectedly demands my full attention, like this good looking person approached me to ask for something. It's like my brain was "held up" like a hostage so it was forced to focus only on this one situation. It's happened only two times but nevertheless it's been exiting cause the T felt gone for 20 seconds or so, then it came back full on. Wish science could come up with a device or drug that could simulate these phenomenas, just as a time based relief or something. Like having a pause button in my pocket with a wireless connection to a brain implant. Probably sci-fi but still just something that could affect the way the brain perceives this god damn T noise.
 
Most of us who have taken benzos like clonezam, Xanax, can verify that these drugs can reduce tinnitus. The problem is, when you take a benzo, your whole brain gets it. If something like a benzo, or better, can be administered locally to the nerve that is causing tinnitus, that approach makes a lot of sense.
My experience is that Xanax (or Xanor as it's named here) doesn't reduce T itself but it gives me a small mental break, it makes it a little easier to have the curse. It takes the edge of the agony for a short while, so it has the potential to be a two edged sword. Like everything that works like that it could fast become a drug abuse. If drugs like that was perfectly healthy I would be consuming them as M&M's.
 

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