Advice Pool - Health and Fitness

I have always had a hearing impairment. I was born with a 70% hearing loss in both ears. While I had a mother who was sensitive to my disability, I never believed there was anything wrong wth me. As a child, I re

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

fused to wear hearing aids.

When, at 19 years-of-age, I bought one hearing aid, it was as if someone turned the sound up. I felt even more invincible. By the time I was 30, I knew I needed aids in both ears. It

; 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 not for 25 more years that I would learn that hearing aids alone were not enough.

Granted, most persons who don’t hear very well do need hearing aids. If they think they will look stupid wearing aids, these p

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

ople have no idea how stupid they appear to others without them. When one gives crazy answers to sane questions ~ and misunderstands what others say ~ they don’t appear to be very bright. Amplification normally h

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

lps a great deal, even if perfect hearing is not attainable for many of us.

Consider this: Use of hearing aids might prevent you from being diagnosed as senile when you get older or loose the understanding compa

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

Combination pro

ion who has always made allowances for you.

Yet, even with good hearing aids, I have only now come come to understand that it is my responsibility to not do those things which irritate normal hearing people ~ wh

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

n I can control those very things.

If I am in another room, I have no business asking questions ~ or initiating conversations ~ which I will likely not hear right. To do so can only cause a person with normal he

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

ring to take on unearned aggravation.

If I wish to engage in a conversation, I should make certain that the other person is close enough for me to have the best chance of hearing. And when others speak to me, as

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

that they do so in a hearing environment where I will understand ~ “Because I don’t want to ask you repeat yourself.” I expect the same courtesy of others that they should reasonably expect of me.

When I enter

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

room and see some people cocking their heads, looking at the ceiling confused, I should be sensitive enough to realize that my hearing aids are probably on too loud without someone asking, “What’s that noise?” Y

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

s, often in an effort to hear better, I have cranked my hearing aids up to a point of “Feedback” which ~ although I can not hear it ~ many people do. Frustrated, associates have screamed, “You’re beeping!” Perhap

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

Following aspects would a

s, my right to hear should be restricted to the point where other people’s sanity endures?

I have great difficulty communicating on the telephone. It was not uncommon for me to already be on the phone and to req

dd to the challenges in developing combination products:

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

est assistance of the closest person to me to be my ears ~ for just a moment. I expected that person to drop everything and help me. How unfair? I have sense learned to say, “In a few minutes, I need to make a ca

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

l. When you are free, would you mind being my ears if I need some?” I no longer expect everyone to allow me to interrupt them just because ~ through my lack of planning ~ I need help “Now!”

While I am on the sub

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

ect, we who require special effort on other’s part to engage in conversation with us, need to learn not to begin talking to them if they are engaged in an activity which will necessitate their relocation to accom

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

odate us, allow us to see their lips, etc.

Hopefully, I’ve learned I don’t have to talk all of the time. All of my life, I had attempted to masquerade as a normal person. The fact is, if you can’t hear ~ you are

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

Professional from academic institutions, pharmaceutical industries, health care indust

not normal! While really not wanting my captive audience to talk ~ because I knew that I would not be able to hear what they said ~ it was much easier to talk than to listen.

Now, I tell the truth. “I can’t hear

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

what you are saying. It is not your fault, but my poor hearing. Please speak more loudly to me. And if I give you an inappropriate response, I will not be offended if you tell me that you don’t think that I under

.

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

tood what you said. In fact, I’d really appreciate it.”

My best advice to persons who can’t hear: Don’t try to “Fake it.” Maybe, you will get away with making like you understand the conversations? Yet, more tha

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

Companies that provide selfless information through particip

likely ~ and more often than you will ever know ~ others will think that you really didn’t care what they had to say.

Being hearing impaired is hard ~ not just on we “Deafies” ~ but those who put up with us too

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 - Hearing Impaired? Hearing Aids? Advice for 'Deafies' and Those Who Put Up with Us

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