Hearing Aids Online and the FDA

The US Food and Drug Administration requires manufacturers to print the following paragraphs in user instructions.

Following the medical evaluation, the physician will give you a written statement that states that your hearing loss has been medically evaluated and that you may be considered a candidate for a hearing aid. The physician will refer you to an audiologist or a hearing aid dispenser, as appropriate, for a hearing aid evaluation. The audiologist or hearing aid dispenser will conduct a hearing aid evaluation to assess your ability to hear with and without a hearing aid. The hearing aid evaluation will enable the audiologist or dispenser to select and fit a hearing aid to your individual needs. If you have reservations about your ability to adapt to amplification, you should inquire about the availability of a trial rental or purchase option program.

Many hearing aid dispensers now offer programs that permit you to wear a hearing aid for a period of time for a nominal fee, after which you may decide if you want to purchase the hearing aid. Federal law restricts the sale of hearing aids to those individuals who have obtained a medical evaluation from a licensed physician. Federal law permits a fully informed adult to sign a waiver statement declining the medical evaluation for religious or personal beliefs that preclude consultation with a physician.

The exercise of such a waiver is not in your best health interest and its use is strongly discouraged.

Children With Hearing Loss:  :In addition to seeing a physician for a medical evaluation, a child with a hearing loss should be directed to an audiologist for evaluation and rehabilitation since hearing loss may cause problems in language development and the educational and social growth of a child. An audiologist is qualified by training and experience to assist in the evaluation and rehabilitation of a child with a hearing loss.

Sound Advice on Hearing Aids

If you suffer from a hearing impairment like 21 million other Americans, you may consider buying a hearing aid. Before you do, determine whether a hearing aid will work for you and what to look for when shopping for one.

How does a hearing aid work?
A hearing aid is an electronic device with a small microphone that amplifies weak sounds through a small speaker. You must have some ability to hear for the device to work. And because hearing loss affects people in different ways, you need to get the right device for you.

Why do people lose their hearing?
Medically, there are two major types of hearing loss. Conductive hearing loss involves the outer and middle ear. It usually results from a wax blockage, a punctured eardrum, birth defects, ear infections, or it may be genetic. Conductive hearing loss generally can be corrected surgically.

Sensorineural—or "nerve"—hearing loss involves damage to the inner ear. It can be caused by aging, prenatal and birth-related problems, viral and bacterial infections, genetics, trauma (such as a severe blow to the head), exposure to loud noises, the use of certain drugs, or fluid buildup or a benign tumor in the inner ear. Sensorineural hearing loss usually can't be repaired surgically; it's usually corrected with a hearing aid.

Where can I buy a hearing aid?
"Dispensers"—merchants or audiologists—sell hearing aids. Ask friends or family for referrals. You also can check out prospective dispensers with your local Better Business Bureau, consumer protection agency, or state Attorney General. Your state or local consumer protection office may have records of complaints against dispensers or physicians, and can tell you how they responded to the complaints. Consumer protection officials also can tell you whether dispensers or audiologists must be licensed or certified by the state.

How can I tell whether I need a hearing aid?
Get an ear examination from a licensed physician. An examination will insure that there are no underlying illnesses or medical problems associated with the hearing loss: sometimes a hearing loss can be a symptom of a medical condition. As a result, you'll want to be wary of advertisements for hearing aids that dismiss the need for an examination—the distributor may be selling inadequate products. In addition, don't feel pressured into buying a hearing aid—ask for more information or a second opinion.

You also should get a hearing evaluation from a dispenser or an audiologist. The cause and severity of hearing loss varies from person to person. An evaluation will help a dispenser or audiologist select and fit you with an appropriate hearing aid.

Can I get a trial period?
Many states recommend or require that consumers get at least a free 30-day trial period. There usually is a service fee—five to 20 percent of the purchase price—if you return the hearing aid during that time. In fact, many manufacturers will make adjustments during the trial period, and allow returns within 60 to 90 days of purchase at no charge to the dispenser.

Buying a hearing aid from a door-to-door salesperson or through the mail is risky. If you buy from a door-to-door salesperson at any location that is not the salesperson's regular place of business, you have the right to cancel any sale for $25 or more within three business days.

Some states don't allow hearing aids to be sold through the mail. That's because it's hard to get a proper fit. If your state does allow mail-order sales, federal law requires companies to ship your purchase when promised and give you the option to cancel the order for a refund.

What about purchase agreements?
The hearing aid purchase agreement—or contract—should include all terms of the transaction, including a clear explanation of all verbal promises. In reviewing your agreement, consider the following:

Is the warranty honored by the manufacturer or by the dispenser? In some cases, a manufacturer may not honor its warranty unless the hearing aid is purchased from a seller authorized by the manufacturer.

What services—if any—will be provided free of charge, and how long will they be provided?

Will I get a "loaner" if my hearing aid needs repair?

What are the federal standards for hearing aid sales?

The Federal Trade Commission (FTC) is responsible for monitoring the business practices of hearing aid dispensers and vendors. The FTC can take action against companies that mislead or deceive consumers. Such companies may use misleading sales and advertising practices—giving inaccurate information about hearing loss, hearing aid performance, refund policies, or warranty coverage. The law further requires companies offering warranties to fully disclose all terms and conditions of their warranties.

The Food and Drug Administration (FDA) enforces regulations that deal specifically with the manufacture and sale of hearing aids. According to the FDA, the following conditions must be met by all dispensers before selling a hearing aid:

Dispensers must obtain a written statement from the patient, signed by a licensed physician. The statement must be dated within the previous six months, state that the patient's ears have been medically evaluated, and that the patient is cleared for fitting with a hearing aid.

A patient age 18 years or older can sign a waiver for a medical examination, but dispensers must avoid encouraging the patient to waive the medical evaluation requirement. Dispensers also must advise the patient that waiving the examination is not in his best health interest.

Dispensers must advise patients who appear to have a hearing problem to consult promptly with a physician.

The FDA regulations also require that an instruction brochure be provided with the hearing aid that illustrates and describes its operation, use, and care. The brochure must list sources for repair and maintenance, and include a statement that the use of a hearing aid may be only part of a rehabilitative program.

What are the state standards for hearing aid sales?
Many states have laws governing hearing aid sales. Most states license hearing aid dispensers. You also may be protected by implied warranties created by state law. Your state Attorney General's office can tell you what laws apply to hearing aid sales in your state.