New Federal Regulations – Strict Control Over Hearing Aids


The Federal Government has finally stepped into the hearing arena with new regulations that establish guidelines for the manufacturing, labeling and selling of hearing aids to the millions of people who suffer from some form of hearing impairment. The hearing impaired individual will now be required to obtain a letter from their physician stating the medical necessity of aid before they are able to purchase a unit. One reason for this rule is the stunning revelation by the FDA that over 10 million hearing impaired Americans have never had any related medical examination. The medical evaluation has to have taken place within the last six months before the purchase of a hearing device.

It is however possible for those of 18 years old or more to sign a waiver and avoid a medical examination, although the hearing aid dispenser is required by law to advise against this. You may be surprised to learn there are over 1,200 different types of hearing aids on the market today. The market share is split between 60% being elderly, 12% being children and the remainder being 18-65 year olds. Along with these new regulations it is now required by all manufacturers of hearing aids to supply detailed literature with each hearing aid, this brochure should cover how to use the hearing aid, how it will work, what you can expect it to do for your hearing and what it will not be able to do.

The leaflet must also explain that hearing aids only magnify sound, they do not regenerate your sense of hearing or prevent any additional hearing loss. Before accepting your money the hearing aid dispenser is required to show you these brochures. If you experience any of the following, the brochures advise you to seek professional advice, symptoms such as deformity of the ears, pain or fluid build up, dizziness, foreign bodies in the ears or what appears to be quickly degrading hearing.

After providing somebody with a hearing aid the retailers are obligated to hold onto all documentation of the transaction for at least 3 years, this includes the medical forms and waivers. The Department of Health, Education and Welfare published a report or hearing aid and health care in 1975 which serves as the basis for the new regulations. The Federal Trade Commission made several recommendations for regulating hearing aid purchase plans and hearing aid advertising which have also been adopted by the new FDA regulations.

The new rules are meant to guard patients against sales solicitations for it which are not likely to improve their situation, and to encourage them to seek a physician’s analysis regarding the causes of their impairment. The big picture goal here is to give information to consumers that they can use to protect themselves from purchasing a this device that they don’t really need. The aim is to provide people with all the relevant information before they buy and get the medical attention those who do not really need a aid require.

Even without these federal regulations, patients should be responsible enough to protect their hearing from fraud or ineffective remedies. It is important people go to a physician for an examination. this is not only due to aging, it can be a symptom of many different things. There is a chance a it will not even help you, instead you may need surgery, drugs or perhaps even simply a change in your diet. However if it is determined you do need a this you will quickly be referred to the appropriate people. As with any new appliance, do some comparison shopping, and make sure you look at not just the final full cost but the service plan as well.

Warranties are also an important thing to look for when buying a it. You will find the majority of manufacturers offer guarantees against faults for around 2 year, you can also ask about trial periods before you purchase. You may even rent a aids, or look into lease purchase plans in which the rental is deducted from your purchase. This can help you to try the device before you buy it. Make sure the sound quality is good, can you easily hear people in a quiet room? Can you hear well in loud places, do you find the hearing aid comfortable to wear? Is it comfortable to wear and easy to operate? Notice the difference between how complex a this is and how much it costs. Top of the line can carry a price tag in excess of $356 but the average cost for a satisfactory unit is generally between $195 and $250.

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