10 years experience
Customer from 100 + countrys.
You’ve likely seen them advertised on television—small electronic sound amplifiers that allow users to enjoy nighttime TV without disturbing sleepers, or to hear their toddlers from many yards away.
While these personal sound amplifiers may help people hear things that are at low volume or at a distance, the Food and Drug Administration (FDA) wants to ensure that consumers don’t mistake them—or use them as substitutes—for approved hearing aids.
“Hearing aids and personal sound amplification products (PSAPS) can both improve our ability to hear sound,” says Eric Mann, M.D., Ph.D, deputy director of FDA’s Division of Ophthalmic, Neurological, And Ear, Nose, and Throat Devices. “They are both wearable, and some of their technology and function is similar.”
Mann notes, however, that the products are different in that only hearing aids are intended to make up for impaired hearing.
He says consumers should buy a personal sound amplifier only after ruling out hearing loss as a reason for getting one. “If you suspect hearing loss, get your hearing evaluated by a health care professional,” he adds.
Choosing a PSAP as a substitute for a hearing aid can lead to more damage to your hearing, says Mann. “It can cause a delay in diagnosis of a potentially treatable condition. And that delay can allow the condition to get worse and lead to other complications,” he says.
Treatments for impaired hearing can be as simple as removal of a wax plug in the doctor’s office or, in rare cases, as serious as a major surgery to remove a tumor or growth in the middle or inner ear, says Mann.
In March 2009, FDA issued guidance describing how hearing aids and personal hearing amplifiers devices differ.
The recently issued guidance defines a hearing aid as a sound-amplifying device intended to compensate for impaired hearing.
PSAPs are not intended to make up for impaired hearing. Instead, they are intended for non-hearing-impaired consumers to amplify sounds in the environment for a number of reasons, such as for recreational activities.
The difference between PSAPS and hearing aids are among the topics covered in a new Web page devoted to hearing aids that FDA launched today.
Mann says that consumers who suspect they suffer from hearing loss should obtain a thorough medical evaluation, preferably by an ear specialist, to identify any medically or surgically treatable causes of hearing loss. Persons exhibiting symptoms of hearing loss should see a doctor or hearing health care professional to have their hearing tested.
You may have hearing loss if
–Number of ears impaired (one or two)
–Stated hearing loss (Mild, Moderate, Severe, Profound)
–Scores on 6 APHAB-EC – like questions (Scaled 1-5)
–When NOT using a hearing aid, how difficult is it for you to follow conversations in the presence of noise
impaired in the sample)
Hearing amplifiers are good for anyone who just wants to hear things louder. For example, people with normal hearing might sparingly use an amplifier for activities like birdwatching. You can think of amplifiers as binoculars for your ears: they zoom in on what you can hear already so you can appreciate it a bit more.
The best way to answer this question is by getting your hearing tested. If you have trouble understanding speech or you listen to the TV too loud, then it might be time to visit your local hearing specialist. They will be able to tell you if you’re experiencing hearing loss and would recommend hearing aids. Don’t assume your hearing isn’t that bad. Seek the help of a hearing care professional so that you make the right decision.
The hearing aids amplifiers adoption rates for age 34 and uders is 31%, the hearing aids amplifiers adoption rates for age between 35 to 64 is 20%, the hearing aids amplifiers adoption rates for age 65+ is 40%. [USA]
From The European Hearing Instrument Manufacturers Association (EHIMA) hearing aids research , 48% of owners/users who got hearing aids amplifier in last 5 years get regularly improve qulity of life. and 40% got Occasionally improve , 9% got rarely improve. Only 2% get never improve.
Licensed hearing aid distributors provide several products that help boost the hearing ability of their clients. Like many other medical equipment distributors, hearing-device suppliers must obtain the proper licensing to operate. You can set up a distributorship with the appropriate educational and legal requirements.
You should check with your state for specific regulations on hearing aid distributors, but in California, you must be at least 18 years old to receive a license for selling hearing devices. California also requires that applicants be state residents and that they must submit to a fingerprint analysis. Some states run a felony background check on the applicant. It is important that you honestly report any felony convictions on your application. Some types of felonies can make you ineligible for testing.
Generally, you can receive your license in two ways: through an apprenticeship or by taking state tests. To become an apprentice, you’ll need to find a licensed hearing aid dealer and apply for an apprenticeship. If you are successful, you must complete up to two years of apprenticeship before you can receive an license. Anyone who meets the statistical requirements can take the state test. Hearing device licensing tests are divided into two main tests: an audiogram and a laws and rules test. You must apply at the secretary of state’s office or through the state’s website.
People seeking a license for hearing aid distribution will have to pay for all study aids, classes recommended by the state and finally for the licensing test itself. Once you pass the exam, you can apply for a state license. You’ll be prompted to pay an application fee by check or with a credit card during the application process. Prices vary according to the type of license you are applying for. For example, a temporary or apprentice license will cost less than a full license.
Georgia requires distributors to follow certain restrictions and rules; your state will have its own rules. Understand these restrictions by reviewing the information provided by your state’s licensing board. Some examples of restrictions you may see are only selling your products directly to the customer or restrictions from selling products to other distributors, licensed or non-licensed. Also, some state-licensed distributors can only operate from locations that meet the state’s criteria, such as a licensed store or franchise branch. Any infractions of the license agreement can result in the loss of your license and possible fines.
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