Advice Pool - Health and Fitness

On a scale of one to ten, how would you rate your tinnitus? If you rated it higher than a five, then it’s most likely that the constant ringing in the ears is interfering with your ha

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

ppiness, your life, and your well being.

Occurrences of tinnitus are on the rise and noise induced tinnitus seems to be the one making the most headlines, due to the expressed concern

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

over iPods and other music related sound systems. There still seems to be quite a lack of awareness out there about the dangers of noise induced hearing loss and tinnitus.

You don’t

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

ave to look far to find evidence of that. Just walk into your nearest movie theatre and feel the noise decibels penetrate your entire body. The audio levels are very often so unneces

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

sarily loud that it borders on noise pollution! I actually wear ear plugs when I go see movies. Most people don’t have a problem with the volume though. Well, at least not until th

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

y wake up one day with chronic tinnitus.

Though I am a huge advocate of live music, mainly because that’s what I do for a living, I’m still dismayed to see concert goers hanging out r

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

ight beside the speakers! There are no warning signs that indicate “danger, close a proximity to these devices may cause hearing loss or tinnitus.” Maybe there should be a law that o

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

bliges festivals, clubs, and venue owners to promote awareness against temporary or permanent hearing loss and tinnitus caused by exposure to loud noise.

There is no cure for tinnitus

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

And, most insurance companies still do not recognize tinnitus as a debilitating condition and therefore will not cover medical expenses or loss of income caused by chronic suffering.

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

However, tinnitus is often severe enough for many sufferers to seek medical attention. And, as most tinnitus patients will tell you, it is a long road ahead for anyone looking for r

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

lief from tinnitus symptoms. Finding relief can be an expensive journey. Many are spending anywhere from $100/month on anti-depressants to $2,500.00 for tinnitus retraining therapy.

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

In many cases, patients will spend thousands more on anyone or anything that will give them promise of relief.

There has been continuous research both in the medical and scientific f

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

ields for a cure. However, I wonder how difficult it must be to compete for funding in the face of other epidemics like bird flu, aids, and rising cancer rates. How many people must

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

uffer from tinnitus before the pharmaceutical companies spend large budgets on research? Any search on Google will reveal that millions are already suffering from tinnitus and this is

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

a real serious global medical problem.

But, the biggest question still remains; why are we not doing more to create awareness about noise induced tinnitus? We are a socially responsib

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

e society, are we not? We properly label cigarettes, trans fat products, age-appropriate toys, movies, games and dangerous goods. It seems to me that the next step may be to lobby ma

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

nufacturers to put warning labels on their audio systems and make the event producers give clear warnings at their loud events. These notices could read something like, “loud noise exp

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

osure can cause temporary or permanent hearing loss and tinnitus.”

Exactly how long will the insurance companies, manufacturers, event producers and government officials try to ignore

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

this growing world wide epidemic? Exactly how long will it be before this collective pool of millions of people get together to affect corporate change and ask for warning labels on l

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

oud noise producing products? How long will it be before the insurance companies recognize tinnitus as a medical issue? How long will it be before the message goes out loud and clear

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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