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The United States Food and Drug Administration (FDA) considers hearing aids to be prosthetic medical devices that provide therapeutic benefits to hearing. Any company or person involved in the manufacture or sale of hearing aids must comply with the FDA regulations for these products, to protect the patients who use this form of health care.

Following is a summary of basic information about hearing health care. If you need hearing aids or assistive listening devices, take a few minutes to learn about the regulations, which include your rights as a hearing health care consumer.

What is a hearing aid?

According to Title 21 of the Code of Federal Regulations (CFR), a hearing aid is a "wearable sound-amplifying device that is intended to compensate for impaired hearing...[it] includes the air-conduction hearing aid and the bone-conduction hearing aid" (CFR Title 21, Chapter I, Subchapter H, Section 874.3300 (a)).

More specifically, a hearing aid is "any wearable instrument or device designed for, offered for the purpose of, or represented as aiding persons with or compensating for, impaired hearing" (CFR Title 21, Chapter I, Subchapter H, Section 801.420 (a) (1)).

There are many styles and brands of hearing aids, with recent technology allowing for sophisticated sound amplification of nearby speech, along with simultaneous background noise reduction. In general, less-visible hearing aids are more often appropriate for people with milder hearing loss, while the amplification strength necessary to provide benefit to people with more severe hearing loss usually requires larger (often the "behind-the-ear" style) hearing aids.

One way to start thinking about which hearing aid is right for you is to make a list of all of the listening situations and environments that are challenging for you without hearing aids. Some examples include watching television, hearing groups at work, driving in traffic, using the phone, attending large lecture classes, and power-walking around the neighborhood.

A good hearing aid dispenser will use your information along with the data from your hearing aid evaluation and tests to suggest hearing aids that can work well in your daily activities. Ultimately, the only way you that will know if a particular hearing aid is a good match for your life is to try it out, ideally for a few weeks. Many dispensers offer a 30-day trial period; typically, if you return the hearing aids, you receive a refund for the purchase price, less a "fitting fee" or similar charge for the dispenser's time. If your dispenser does not offer a trial period, go to another dispenser who does.

You can think of this trial process as "trying on" hearing aids, just as you try on clothes before you buy them. A camisole or a pair of jeans may look terrific on the rack, but not fit quite right. And, conversely, a pair of boots may look only so-so on a display shelf, but wind up being more comfortable and flattering than any other footwear you've ever worn.

One more note about hearing aids for fashionistas: Earmolds--the plastic part that fits in your ear--along with many hearing aids are now available in a rainbow of colors, so you can pick your favorite and make a bold fashion statement while improving your ability to communicate. While the stigma surrounding hearing loss use unfortunately persists in this new century, it is a lot less fashionable to have to keep asking, "What did you say?" or to jeopardize your safety because you can't hear well!

Who may sell hearing aids?

Hearing aid dispensers include "any person, partnership, corporation, or association engaged in the sale, lease, or rental of hearing aids to any member of the consuming public or any employee, agent, sales person, and/or representative of such a person, partnership, corporation, or association" (CFR Title 21, Chapter I, Subchapter H, Section 801.420 (a) (3)).

Audiologists and physicians specializing in ear diseases can be dispensers, but dispensers are not necessarily audiologists or physicians. Dispensers may have traditional bricks-and-mortar offices, and they may also market their products over the Internet. Internet-only dispensers often work with multiple office-based dispensers. You can order hearing aids online, but for most models, you will still need to go to a dispenser's office for earmold impressions and hearing aid programming. Getting the best fit and programming possible will greatly increase your comfort, and reduce the likelihood of that squeaky feedback.

Requirements and qualifications for dispensers vary by state, as do policies governing the sale of used hearing aids. Dispensers must provide everyone who purchases a hearing aid with information on the use and care of the aid, as well as a specific address to which a hearing aid may be sent for repairs. New hearing aids should come with at least a one-year warranty from the manufacturer; some dispensers also offer extended repair coverage after the initial warranty period expires.

The full text of the FDA regulations for labeling hearing aids is available in CFR Title 21, Chapter I, Subchapter H, Section 801.420 (b)).

What are the medical requirements for purchasing hearing aids?

The FDA mandates that a consumer must have a medical evaluation by a licensed physician (preferably, but not necessarily, one who specializes in diseases of the ear) within six months of a hearing aid purchase. If the consumer is at least 18 years old, she or he can waive the medical evaluation requirement (CFR Title 21, Chapter I, Subchapter H, Section 801.421 (a) (1) and (a) (2)).

The medical examination is strongly recommended. Sometimes, diseases, wax buildup, or other factors can cause hearing loss, and hearing aids might not help in those situations. Many health insurance policies will cover the medical examination, as long as a primary care physician approves it. Check with your health plan administrator, and get all confirmations in writing.

What about regulations for assistive listening devices?

The FDA classifies an assistive listening system as a "group hearing aid or group auditory trainer...intended for use in communicating simultaneously with one or more listeners having hearing impairment," including "hardwire systems, inductance loop systems, and wireless systems" (CFR Title 21, Chapter I, Subchapter H, Subpart D, Section 874.3320 (a)).

Common types of these devices include FM and infrared listening systems found in movie theaters, courtrooms, and college lecture halls. Group auditory trainers are exempt from the conditions for sale that apply to hearing aids, including the requirement for a medical evaluation or the waiver of an evaluation (CFR Title 21, Chapter I, Subchapter H, Section 801.421 (c) (2) (e)).

Manufacturers can decide for themselves if they are marketing a medical device subject to FDA oversight, or a consumer product not regulated by the FDA. It is appropriate to be concerned about the potential for damaging your hearing that is allowed by this glitch in current regulations. While it is reasonable to expect that manufacturers and dispensers are ethical and responsible, profit goals and the limited government resources for protecting consumers of hearing health care products are valid reasons for each customer/patient to be diligent about the hearing health care that she or he buys.

Certainly, medical devices labeled and approved as such by the FDA can cause harm; a licensed and experienced audiologist can, for example, mistakenly program hearing aids to over-amplify for a particular patient, and consequently make a noise-induced hearing loss worse. Also, audiologists and other hearing aid dispensers may sell devices inappropriate for a particular patient's hearing loss, causing further auditory damage. And a manufacturer of an FDA-approved medical device may build faulty products through human or other error after receiving government approval. If such an event were to occur, a patient could file a complaint with the FDA for investigation. No such oversight can occur with consumer products. The lack of accountability from a health care perspective required of consumer product manufacturers makes our jobs--as hearing-impaired health care consumers--even more challenging and important.

Increasing funds for oversight and consumer protection in hearing health care, and updating the 1977 regulations to make them applicable to 2007 technology, should be priorities of elected government officials. The number of people with hearing loss in the United States will continue to increase as noise-induced hearing loss affects more members of the non-elderly population, and as more people grow older and experience age-induced hearing loss. Providing justified, feasible, and timely parameters to manufacturers and dispensers, while encouraging continued technological innovation, will benefit the growing numbers of hearing health care consumers now and in future decades.

Read previous Policy Vibe articles in the Archives

Coming soon in The Policy Vibe:

• The quiet backlash
• Insurance coverage for hearing aids--the why behind the why not
• The politics of hearing loss

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