President Donald Trump recently signed the U.S. Food and Drug Administration Reauthorization, which included the Over-the-Counter Hearing Aid Act originally proposed by U.S. Sens. Elizabeth Warren, D-Mass., Chuck Grassley, R-Iowa, and U.S. Reps. Maggie Hassan, D-N.H., and Johnny Isakson, R-Ga.
The measure is intended to increase consumer buying power by reducing the costs of hearing aids while maintaining existing safety, labeling and manufacturing protections, and the same high standards as other medical devices, according to congressional records.
Yet the bill was not without its detractors, including the hearing aid industry and audiology groups, which have vowed to fight on during the upcoming regulatory approval process.
The industry groups have argued that the over-the-counter devices only be allowed for people with mild hearing loss, suggesting that the new law would cause more harm than help for those with moderate hearing loss.
The bill, widely supported by consumer groups such as the Hearing Loss Association of America and the Consumer Technology Association, received overwhelming bipartisan congressional support.
Hearing aids are expensive, with a mean cost of $4,700 for 2 hearing aids, according to a recent study by the American Medical Association.
The study, reported in the Journal of the American Medical Association, found that less than 20 percent of adults with hearing loss report using hearing aids that are not uncovered by Medicare or health insurance plans.
Another recent JAMA study compared personal sound amplification products with hearing aids and found that these amplification products were technologically comparable with hearing aids and may be appropriate for mild to moderate hearing loss.
The study compared a sample of currently available amplification devices with conventional hearing aids among individuals with mild to moderate hearing loss.
The hearing aids and personal amplification devices, which all work the same way, were found to improve hearing from 88 percent for those using conventional hearing aids compared to 77 percent for those using the amplification devices.
According to the National Institute on Deafness and other Communication Disorders, most adults who have hearing loss would benefit from the use of hearing aids, yet the high cost has been the major barrier to their use.
A report by the President’s Council of Advisors on Science and Technology indicated that doctor visits and evaluations by an audiologist, fittings, adjustments and modifications, and the lack of competition among hearing aid manufacturers have driven up prices.
According to the Consumer Technology Association, 1.5 million devices designed to amplify ambient sounds are expected to be sold in the U.S. this year.
The association expects that lower prices are likely to be a major advantage of over-the-counter hearing aids, which may range between $270 and $350 apiece.
Unlike glasses that can correct vision loss, current hearing aids cannot correct or restore normal hearing. Instead, they improve the audibility of soft sounds such as speech or music and ensure that other audible sounds do not interfere by becoming too loud.
Andy Winnegar has spent his career in rehabilitation and is based in Santa Fe as a training associate for the Southwest ADA Center. He can be reached at firstname.lastname@example.org.