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    Cause and effect of using silicone based hearing protection

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    Employer is requiring the use of silicone based hearing protection which is less effective in abating noise than current foam hearing protection. Curious whether research exists on short/long term effects of putting silicone into the ear for up to 10 hours/day.

    What is the cause and effect of using silicone based hearing protection?

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    sil·i·cone (s l -k n )
    Any of a group of semi-inorganic polymers based on the structural unit R2SiO, where R is an organic group, characterized by wide-range thermal stability, high lubricity, extreme water repellence, and physiological inertness and used in adhesives, lubricants, protective coatings, paints, electrical insulation, synthetic rubber, and prosthetic replacements for body parts (http://www.thefreedictionary.com/silicone).

    So, what is said about silicone ear devices?
    These devices are custom moulded in a silicon material. Each ear mould is individually made to offer maximum comfort and protection. They are non-allergenic and hygenic. All of our ear protectors are manufactured to an extremely high quality and are C.E. certified. (http://www.audi-lab.com/earprotectors.htm).
    Yet another says this,
    First, silicone plugs are made of skin-soft materials are carefully custom fitted. Each protector follows the exact configurations of an individual's ear, and tightly occludes without discomfort. They have no pressure points, no hot spots, no sound leaks, and no chance of being poorly seated in the ear (which would lower effectiveness).
    Second, silicone plugs have no working parts to wear out or break down. Along with the custom mold, they are non-toxic, anti-allergenic, and 100% safe. A channel in the ear mold guarantees permanent placement and optimum noise reduction.
    Custom silicone earplugs are so comfortable and so effective that worker acceptance is extremely high. Employees find they can carry on normal conversation, answer telephones, hear alarms, even machine malfunctions, change elevation and move from high to low noise levels without adjusting or removing the devices. No stopped up feeling either, since the earplugs are designed to allow both air and sound up to 80 dB to enter the ear virtually unrestricted. We have found that over 70% of individual users actually also take their earplugs home for off-the-job protection while using chain saws, lawn mowers, motorcycles, shop equipment, hand guns, watercraft or aircraft and other noise-intensive activities. (http://www.hear-more.com/earplugsindustrial.htm).

    All materials and colors are FDA approved

    Silicone earplugs come in a variety of colors including flesh, brown, clear and safety orange. All materials and colors are FDA approved. Each set comes complete with a removable neck cord in red or orange. To facilitate placement in the proper ear, a color marking is placed on the right ear protector and on the right side of the neck cord for each set. (http://www.hear-more.com/earplugsindustrial.htm)."

    So the question becomes, what does being "FDA Approved" mean?
    The United States Food and Drug Administration (FDA) is the federal governmental agency charged with protecting the health and welfare of the American public through the regulation of food, drugs and medical devices, among other responsibilities.
    It is probably the most critical mission assigned to any of our federal governmental agencies and, as you can imagine, the FDA takes its oversight mission seriously. Its regulations are extremely stringent. Its inspections are thorough. Its penalties for non-compliance are damaging. But when you are talking about food, drugs and medical devices, you wouldn't want it any other way, would you?
    When a company says that the devices are FDA-Approved, it means that EVERY aspect of the device has been scientifically proven to be valid, safe and effective. This involves extensive clinical trials with hundreds of patients, backed up by voluminous documentation and verification of the clinical trail results. (See website http://www.thefreedictionary.com/FDA which describes the five phases of clinical investigation that occur prior to approval of medical devices and the likes). However, for some products, FDA may approve a device but include circumstances where potential problems with the device (see http://www.spychips.com/reports/verichip-fda.html). It is up to the employer to know these potential problems and NOT implement medical devices in any of the potential problems conditions as suggested by FDA. However, I am not aware of any such conditions placed on silicone hearing protection devices.
    It is against the law for any product or service to claim it is FDA-Approved when it isn't. And when a product isn't FDA-Approved it means that FDA hasn't been afforded the opportunity to review or pass judgment on any data or science connected to a specific product's claims. (http://www.hiv-tests.com/fda.html).

    FINAL COMMENTS: Through my extensive Internet search, I have not come across one single study suggesting that silicone hearing devices have any negative implications. Of course, most products come with a warning ABOUT POSSIBLE ALLERGIES TO THE PRODUCT and, in that case, the person should discontinue using the product immediately (i.e., when an allergic reaction occurs). Although, my literature search was not, by any means, all inclusive or exhaustive, it seems reasonable to conclude that because of the extensive research that precedes FDA approval, that silicone ear plugs can be worn safely for a ten-hour period for noise. At least for now the devices are deemed safe, although it is always open for review and change (i.e., if negative implications come to the fore concerning silicone ear devices).
    Hearing Protection helps to protect the hearing from permanent noise-induced hearing loss by reducing the noise exposure. Of course, it is up to the employee to be sure that the product of choice reflects the desired noise reduction necessary for the safety of the workers (i.e., hearing loss). This is the ethical responsibility of the employer. There are several types of custom made earplugs, as well as earmuffs, for a variety of environments. For example, one type of earplug protects the ear from loud damaging sounds while still allowing the user to hear normal conversations, and use the telephone. Another type provides a flat frequency attenuator that is important for musicians and others who need to reduce noise but still hear accurately. Another type is perfect for hunters as it "kicks in" when a certain noise level is reached (gunfire) but still allows the ability to hear low-level sounds such as animals scurrying in the brush (http://www.earsite.com/hearing_aids/hearing_devices_acc.html). Employers are responsible for educating the employees about such devices and about what devices best suit their specific type of work environment (i.e., the amount of noise reduction in their work environment). In some case, foam devices may be better than silicone depending on the amount of noise reduction mandatory to keep the environment safe for the ears of the workers (i.e., no hearing loss due to noise). Again, this is the employers' ethical and legal responsibility.
    I hope this helps and take care.

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