Would you be willing to trust your precious hearing to an over-the counter purchase of a hearing aid at your local big box pharmacy?

That is a question being asked as Congress considers legislation which, if approved, would broaden the availability of hearing aids, allowing such devices to be sold over-the-counter to people over age 18 who have "mild to moderate" hearing loss.

A bipartisan bill submitted to Congress in March known as the Over-the-Counter Hearing Aid Act of 2017, would amend the Federal Food, Drug, and Cosmetic Act, and require a set of regulations covering the use of such hearing aids "without the supervision, prescription, or other order, involvement, or intervention of a licensed person."

The legislation, if approved, would create "a category of over-the-counter hearing aids" subject to regulation by the US Food and Drug Administration (FDA). The FDA currently regulates conventional "hearing aids," which are available only through prescription.

The over-the-counter devices would be subject to a new regulations that "would provide reasonable assurances of their safety and efficacy." Those rules would include product labeling information.

Currently on the market are a variety of electronic devices known as "personal sound amplification products." The basic, relatively inexpensive products amplify sound for the benefit of their users, but cannot be advertised as "hearing aids."

The proposal to broaden the availability of hearing aids for people with "mild to moderate" hearing loss is largely based on cost.

The Cost Factor

A pair of hearing aids obtained through an audiologist may cost several thousand dollars, while basic over-the-counter hearing aids would cost significantly less.

Audiologist Stephanie L. Bakewell, AuD, said the positive aspect of allowing over-the-counter sales of hearing aids is making hearing aids available to more people.

Dr Bakewell cautioned, however, that over-the-counter sales may raise false expectations in people because hearing loss is a malady that varies among individuals and warrants scientific testing and equipment customization by an expert to provide the best results.

Audiologist Cathleen A. Alex, AuD, said that the sound frequency response charts created when audiologists test patients are unique documents. Through scientific testing, audiologists address sonic distortion and clarity issues, she said. "Over-the-counter products may not be useful," she noted.

Dr Bakewell and Dr Alex have a joint practice in audiology in Southbury.

Dr Alex explained that testing on a patient measures how well their brain understands sound, in both quiet environments and noisy environments. Through such testing, "We seek to create high-definition hearing" for a patient, she said.

Technology has improved and hearing aids are smaller than in the past, Dr Alex said. Rechargeable batteries are now available from most major hearing aid makers, Dr Bakewell added.

Dr Alex noted that, if approved, the over-the-counter sale of hearing aids would be keyed to providing devices to people who are in the early stages of hearing loss and who are seeking cost savings.

The doctors noted there are different opinions about the wisdom of over-the-counter hearing aid sales. The Academy of Dispensing Audiologists favors the legislation; the American Speech, Language, and Hearing Association opposes the proposed law; and the American Academy of Audiology is neutral on the topic.

Consulting An Expert

Dr Alex, who is president of the Connecticut Academy of Audiology, said there are about 250 licensed audiologists in Connecticut.

She urged that people who would buy an over-the-counter hearing aid to first visit an audiologist to learn about their hearing problem. Hearing loss may be caused by an ear wax buildup, osteosclerosis, middle ear problems, or benign tumors, she said.

Dr Bakewell advised that an audiologist can provide a person with a sonic baseline, through which the quality of their hearing can be tracked across time.

"Hearing is a quality of life issue," Dr Bakewell said.

Audiologist Anne Lynn, of Sandy Hook Center said of the proposed legislation, "I think we have to be very careful with this."

If the proposed law is approved, the federal government would create regulations covering the purchase of over-the-counter hearing aids at pharmacies, she explained.

Ms Lynn said that some of the personal sound amplification products that are now sold are not of good quality. If the legislation is approved and hearing aids are sold over-the-counter, those devices need to be of high quality, she said.

"People don't know how to diagnose their [own] hearing loss," Ms Lynn said.

To suitably deal with hearing loss, people should be tested and fitted with a hearing aid by an audiologist and then be seen in follow-up visits, she said.

Ms Lynn suggested that over-the-counter hearing aids could serve as an "entry level" device, after which users could obtain more sophisticated hearing aids from audiologists, as the need arose.