Advice Pool - Health and Fitness

The ability to hear - music, a lively conversation with friends, and the delightful laughter of a child - is

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

truly a gift to be treasured. As we grow older or become subject to illness or injury, however, we run the

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

Examples of combination products may in

isk of hearing loss, however mild or severe. At times we may not be aware of this condition, whether we have

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

adapted to the loss unconsciously or are too distracted by vanity to admit that there might be a problem. N

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

vertheless, it is important to recognize signs of hearing loss and take action as soon as possible, so no pe

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

Combination pro

manent damage is done.

This self-examination is designed to determine if you need to consult with a physici

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

an about your hearing - it should not be considered medical advice. Oftentimes people may jump to the conclu

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

ion that they need surgery or a hearing aid, when in fact their hearing situation may be less severe. Let th

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

e questions below guide toward the knowledge you need to take to an otolaryngologist - an ear, nose, and thr

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

at specialist.

Problems with the telephone - Do you often experience trouble hearing people on the o

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

her line? Does everybody sound distant, or does there appear to be static on the line all the time?

Conv

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

Following aspects would a

ersations - Do you have trouble following a group conversation? When you're at a party, is it difficult

dd to the challenges in developing combination products:

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

o hear somebody speak over the background chatter? Do you have to strain to hear people speak?

Televisio

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

n and Radio - Do you find yourself constantly turning up your TV and radio so you can hear better? Are f

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

iends and family always complaining about the volume when you sense nothing wrong?

People - Does it

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

lways seem like everybody mumbles when they speak? Are you always having to ask people to repeat themselves?

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

Professional from academic institutions, pharmaceutical industries, health care indust

Do voices always sound slurred?

If you answered yes to three or more of the above, chances the communicati

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

n problems you experience are not attributed to others, but to your growing inability to hear. Only a physic

.

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

ian, however, can make that diagnosis, therefore it is important to consult with your doctor immediately if

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

Companies that provide selfless information through particip

ou suspect hearing loss. From there it can be determined what options are available to preserve your hearing

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 Signs of Hearing Loss

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