Advice Pool - Health and Fitness

Hyperacusis is a medical condition wherein the person’s tolerance for normal sound in his environment is lowered.

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

This lowered tolerance is manifested by the person’s sensitivity to otherwise normal sounds in his surroundings

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

Examples of combination products may in

As a result, he feels as if the whole world is screaming at him. The dripping of water in the faucet, a child

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

rooning to himself, a radio playing from a distance, car horns from the road outside – all these sounds are perce

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

ved by the person with hyperacusis as loud and blaring.

The bad thing about having hyperacusis is that the perso

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

Combination pro

has no way of “turning the sounds off.” Hyperacusis is a chronic disorder and tends to come and go. People who

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

suffer from hyperacusis may also tend to suffer from tinnitus. Tinnitus is the ringing that you hear in your ear

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

. However, hyperacusis may occur in people who have no other hearing problems.

So what can you do to if you hav

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

hyperacusis? Sad to say, but the progression of this disease is quite unpredictable. As of now, the only sure

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

hing that researchers know is that exposure to loud noises contributes to the progression of the disease.

Pink n

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

ise and white noise are commonly used to treat patients. They are quite similar to each other although for pink

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

Following aspects would a

oise, the sounds with lower frequencies are louder than those with higher frequencies. On the other hand white n

dd to the challenges in developing combination products:

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

ise has the same amplitude for all frequencies. The importance of these two types of noise is that they increase

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

the tolerance for the normal range of noise that we hear everyday.

There are some therapy regimens that patients

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

with hyperacusis can go through. One such therapy is the use of special hearing aids for several hours a day. T

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

ese special gadgets work by desensitizing the ears to sound. This treatment is called Tinnitus (Hyperacusis)Retr

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

Professional from academic institutions, pharmaceutical industries, health care indust

ining Therapy or TRT. Another way to treat hyperacusis is to listen to a pink noise CD. This also serves to des

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

nsitize the ears to sound.

Though these procedures have proven to be successful in helping many people suffering

.

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

from hyperacusis, they are not considered as cures. The best course to take when you suddenly find yourself suff

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

Companies that provide selfless information through particip

ring from “loud” noises is to visit your healthcare professional as they can better determine your specific needs

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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