Advice Pool - Health and Fitness

Kids have always loved listening to their favorite music, and the louder the better – much to their parents’ dismay. In the 1980s, the portable tape recorder with headphones – which came to be known as the “Walkman” – enabled teenagers to listen to t

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

heir music as loud as they wanted, anywhere they wanted, without disturbing anyone around them.

But the more modern rendition of the Walkman – portable MP3 Players and iPods – pose a major threat to our children’s hearing health, and to ours.

The p

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

Examples of combination products may in

oblem is a combination of the technology of portable digital devices that creates a non-buffered crystal clear sound, and the type of headphones typically used with them, which do not have a buffer either. In December 2005, Dean Garstecki, an audiolo

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

ist and professor at Northwestern University reported that more and more young people were being diagnosed with the types of hearing loss typically fo

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

nd in older adults. He attributed this trend to the “earbud” type headphones that usually accompany iPod and MP3 Players. With the earbud headphones, the sound frequencies are not buffered as they are with the more traditional, ear cup-style heads

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

Combination pro

ts.

Newsweek Magazine recently reported that researchers at the House Ear Institute found that listeners can unfortunately increase the volume of today’s portable digit

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

l devices without the “signal distortion that occurs with traditional analog audio.” The older-model headphones that were popular just 15 to 20 years ago – that have ear cups outside of the ears – had that distortion when the volume was turned up, wh

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

ch functioned as a much-needed buffer to protect our hearing. Today’s technology does not provide that buffer – the earpiece is placed in the ear, not outside of it, and the digital devices do not create that distortion, no matter how high the volume

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

In addition, people often listen to these devices while they are on the go, and have a tendency to crank the volume in an attempt to drown outside noise, further posing a risk to our hearing. Using the earbud style headphones during activities such

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

as exercise, for example, puts the user at a greater risk. During exercise, blood, which can act as a buffer, is diverted from the ears to other parts of the body – so our already vulnerable hearing is in even more jeopardy.

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

ize.com/articles/hearing_art.htm#airo/" target="_blank">Headwize reports that a study conducted on music listeners using headphones revealed that while indoors with no background noise, the participants were comfortable with their music at 69 dec

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

Following aspects would a

ibels. Outdoors, where the background noise was recorded at 65 decibels, participants using their headphones turned the volume up to 82 decibels and as high as 95 decibels to drown out the surrounding noise. The Occupational Safety and Health Admini

dd to the challenges in developing combination products:

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

tration guidelines limit exposure to noise at this level to no more than four hours each day. The study concluded that the participants were at risk for hearing damage and recommended “avoiding continuous use of [portable stereos] in noisy conditions

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

”

Northwestern University’s Dean Garstecki offers more specific guidelines: His 60 percent/60 minute rule – listen to MP3 Players and iPods for “about an hour a day and at levels below 60 percent of maximum volume.” The problem is, most of the popul

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

tion using headphones – young music fans – listen to their music for much longer than one hour per day. But, you can help minimize hearing loss, damage and problems while listening to your favorite music as long as you want to – the secret is in the

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

eadphones.

Headphones such as the EX29 Extreme Isolation Noise Reduction Headphones help block out external noise allowing you to hear the fine details of your music without blowing out y

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

Professional from academic institutions, pharmaceutical industries, health care indust

ur ear drums. The ear cup fits over the ear, and not in it, and the headphones are lightweight, don’t require batteries and can be used with your MP3 Player or iPod. With 29 decibels of isolation from outside sound, the quiet headphones block outside

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

noise and there is no need to crank the volume of your music.

Aging rock stars like the Who’s Pete Townsend, who has some permanent hearing loss from years of exposure to loud music, and Mick Fleetwood, who has teamed up with Energizer batteries to

.

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

romote hearing loss prevention, have brought public attention to the fact that many of us take our hearing for granted. But there’s no need to turn off your music – just be smarter about how you listen to it. If you are using your MP3 Player or iPod

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

Companies that provide selfless information through particip

hen you’re exercising, in a noisy environment or you just want to hear the fine details of your music, ditch the earbud headphones and reach for a set of noise reduction ones instead. And you’ll be enjoying your favorite music for a long time to come

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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