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This article was originally published in The Gray Sheet

Executive Summary

HEARING AID REGULATION: CHANGING FEDERAL LAW WOULD BE PREFERABLE to granting Vermont's petition to exempt its state law on the sale of hearing aids from federal preemption, the Hearing Industries Association argues in an Aug. 5 letter to FDA Commissioner David Kessler. "If the FDA believes its regulations fail to properly regulate the sale of hearing aids, the government should alter them," HIA asserts. "Granting Vermont's unsupported, ill-advised petition to compensate for perceived inadequacies in the FDA's regulatory scheme for hearing aids is bad policy." The association advises that if FDA is "dissatisfied" with its regulations, the agency should reopen the hearing aid regulation and solicit comments from the public. The answer, they say, is not "to exempt from preemption a state requirement to accomplish an agency end"; that would merely shift "FDA's responsibilities to the states with little consideration of the overall costs to consumers." The letter was submitted as FDA prepares its formal response to Vermont's petition, which is expected to be issued by the end of the summer. The petition was debated at a July 2 meeting between FDA, industry (including HIA) and health professional groups. Also under discussion was the agency's proposal to revise the current hearing aid regulation; the proposal is slated for publication by late August, FDAers say. Under the existing federal reg, hearing aid dispensers are required to obtain either a physician's statement that the patient has had a diagnostic hearing evaluation or a waiver from the examination, signed by the patient, prior to distribution of the device. The dispenser also is required to provide the prospective user with a copy of the "User Instructional Brochure," a document that outlines how to use the device and includes a statement that "good health practice requires that a person with a hearing loss have a medical evaluation by a licensed physician (preferably a physician who specializes in diseases of the ear) before purchasing a hearing aid." Submitted to FDA in 1990, the Vermont petition seeks an exemption from federal preemption of a Vermont state law that allows dispensers to sell hearing aids only if the patient presents a physician's statement that his or her hearing loss has been evaluated ("The Gray Sheet" April 15, 1991, p. 7). The Vermont law does not contain the federal waiver provision. FDA's upcoming revision to the federal law also is expected to eliminate the waiver ("The Gray Sheet" July 12, p. 1). The crux of HIA's argument against granting Vermont's petition is that "it fails to meet statutory criteria for an exemption from preemption." The association points out that the Federal Food, Drug, and Cosmetic Act specifies two bases for exemption from preemption: when "compelling local conditions" require a state law in lieu of federal law; and when the state "law requirement is more stringent than a requirement...which would be applicable to the device if an exemption were not in effect." HIA asserts that Vermont's "averments of compelling local conditions" rest on data which show a high rate of non-compliance with FDA's hearing aid regulation. However, HIA says that Vermont fails to "produce evidence" that the non-compliance is a local phenomenon. "Mere allegations of a pattern of non-compliance with the Act cannot be a basis for a state to usurp the FDA's authority," the group maintains. The second argument to support preemption, that Vermont's mandatory physician referral provision is more stringent than the reg's requirements "is also without merit," HIA says. To assess the comparative stringency of state and FDA rules, the agency should assess "whether the state's requirements will provide more consumer protection" than FDA requirements, HIA says. "The administrative record in the Vermont petition rulemaking fails to show" health benefit to consumers by requiring the initial exams, the group maintains, adding that the Vermont law "will force people to visit doctors, many of whom are ill-equipped to adequately advise and diagnose patients' hearing problems." In contrast, the association continues, the federally mandated "User Instructional Brochure" creates a more "salutary environment for a purchase decision." Availability of the booklet attempts to ensure that consumers are "fully informed regarding the need to see a physician with appropriate expertise prior" to buying the device. "Accordingly, although the Vermont physician evaluation provision may be more restrictive than its federal counterpart, it cannot be considered more stringent than the FDA's physician evaluation/waiver regulation." HIA concludes that "creating rules that differ from FDA's hearing aid regulation will create extra costs to manufacturers . . . that will be passed on to consumers." Unless FDA is sure of a benefit that would justify the additional costs, HIA asserts, it "would be wrong to burden people" with the expense. "One set of uniform rules" to "ensure consumer satisfaction" is necessary, HIA adds, cautioning that exempting Vermont from preemption may "set a precedent resulting in a wide array of state laws or regulations that will needlessly increase the cost of hearing aids."

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