Advice Pool - Health and Fitness

One can argue that our five senses - sight, smell, taste, touch, and hearing - are equally important. Yet, our abil

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

ity to hear is an especially useful and wonderful gift. Through our hearing capabilities we may communicate clearly

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

Examples of combination products may in

with others, be warned of impending dangers, and delight in every day pleasure like a favorite movie or loved one's

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

laughter.

Sadly, some people are not able to enjoy this gift as much as others. Where some people might be born w

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

th hearing loss or difficulty, others may experience hearing loss suddenly or gradually due to various factors. As

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

Combination pro

the ear is a delicate organ, there are many possibilities that can contribute to rendering it unable to function co

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

rectly. Here are just a few of the common causes of hearing loss:

Noise: Common among people who live or wo

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

rk in areas conducive to high-volume sound, constant noise can attribute to one's hearing loss over time. Even with

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

regular ear protection (used by airport workers or construction workers, for example), one might experience a certa

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

in level of loss if continuously exposed to noise. People who attend loud concerts on a regular basis or keep radio

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

or iPod earphones on for extended periods of time are also at risk.

Aging: Growing older is a fact of life.

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, some body parts don't work as well as they did when the body was young, and the ear applies as well

dd to the challenges in developing combination products:

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

As you age, you may experience changes in the nerves and cells in your ear, this is called presbycusis. Whe

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

ther you suffer from mild or complete hearing loss as a result depends on the individual.

Injury: Serious i

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

jury such as head trauma following an assault or accident may contribute to hearing loss if damage is brought to th

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 ear.

Illness: Infections of the ear, such as otitis media which effects the middle ear or otiti

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

Professional from academic institutions, pharmaceutical industries, health care indust

externa of the ear canal (also called "swimmer's ear") can contribute to hearing loss is not treated in a time

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

ly manner. The ear may also be subject to benign tumor growth that blocks the ear canal and prevents one from heari

.

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

g clearly.

Anyone who suspects hearing loss brought on by illness or injury, aging or lifestyle should consult wit

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

Companies that provide selfless information through particip

h a specialist and determine what steps can be taken to preserve hearing ability. This gift is too precious to lose

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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Advice Pool - Common Causes of Hearing Loss

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