Advice Pool - Health and Fitness

Everyone knows what hearing is. Hearing loss, or deafness, is the partial or total inability to hear sound in one or both ears.

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

The human ear is remarkable as is the smallest and most complex organ in the body. Considering the ear's delicacy, it is remar

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

Examples of combination products may in

ably resilient. Nevertheless, illness or injury can impair our ability to hear properly.

It is possible that someone who has h

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

earing loss may be able to hear some sounds or simply nothing at all. Often people also call it deaf, deafness, or hard of hear

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

ng when they're talking about hearing loss.

It has been observed that out of 1000 babies born, three may have hearing impairme

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

Combination pro

t. This is the most common birth defect. Although there is a possibility that hearing problem can also develop later in life, t

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

here are many types of hearing loss:

1. Conductive hearing loss: it is a problem with the part of the outer or middle ear. Mos

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

patients with conductive hearing loss have a mild hearing loss and it is usually temporary because in most cases medical treat

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

ment can help. It could be when one has middle ear infections, collection of fluid in the middle, blockage of the outer ear (by

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

wax), damage to the eardrum by infection or an injury.

2. Sensory hearing loss: This happens when the cochlea is not working c

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

rrectly because the tiny hair cells are damaged or destroyed. Depending on the loss, a patient may be able to hear most sounds

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

Following aspects would a

(although they would be silent); only some sounds; or no sounds at all. Sensory hearing impairment is almost always permanent a

dd to the challenges in developing combination products:

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

d a patient’s ability to talk normally may be affected. It could be due to age-related hearing loss that people experience as t

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

hey get older, injury caused by loud noise to the hair cells, viral infections of the inner ear (may be caused by viruses such

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

s mumps or measles), Meniere's disease (abnormal pressure in the inner ear), a brain tumor or a stroke.

3. Mixed (conductive a

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

d sensory combined) hearing loss: this happens when the outer and middle ear is affected and also the tiny hair cells are damag

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

Professional from academic institutions, pharmaceutical industries, health care indust

ed. This is a very critical case and cannot be cured fully.

4. Neural hearing loss: This happens when there is a problem with

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

he connection from the cochlea to the brain. Neural means related to nerve, so neural hearing loss means the nerve that carries

.

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

the messages from the cochlea to the brain is damaged. In recent years, substantial advances have made it possible to determin

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

Companies that provide selfless information through particip

the cause of hearing impairment in nearly all cases, and to treat the hearing loss in many of them.

Copyright 2006 John Curri

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 - What is Hearing Loss?

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