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AG Nessel Urges FDA to Prioritize Consumer Protection in Regulation of Over-the-Counter Hearing Aids
January 20, 2022
LANSING - Michigan Attorney General Dana Nessel joined two multistate efforts that are urging the U.S. Food and Drug Administration to preserve state authority to enforce their consumer protection laws in connection to the sale of over-the-counter hearing aids.
The FDA is currently considering a proposal that would establish, for the first time, a new category of over-the-counter hearing aids that would allow such devices to be sold directly to consumers without a medical exam or fitting by an audiologist.
"This proposed rule will allow for more affordable and accessible hearing aids, but the FDA must ensure that any action taken preserves states' abilities to protect consumers," Nessel said. "It is imperative that federal regulation not preempt safeguards already in place."
Currently, all 50 states have hearing professional licensing requirements, and many have important protections for hearing aid consumers, including mandatory warrantees and returns and advertising restrictions.
AG Nessel joined two multistate letters - one led by the states of Connecticut and Ohio, and the other led by the state of New Jersey - that ensure consumer protection is given a priority as this proposal is considered by the FDA.
"While the FDA's proposed rule offers consumers much needed relief in the form of more affordable and accessible hearing aids, it could have unintended negative consequences on our constituents. The proposed rule includes broad language that could be interpreted to repeal virtually all the state-requested exemptions from preemption issued by the FDA since 1980 - even those related exclusively to non-OTC hearing aids. Such language could create unneeded confusion and the potential for unnecessary litigation," the Connecticut and Ohio-led comment letter states. "Additionally, we are concerned with the inadequate age verification processes mandated and deficient labeling requirements. Without these proper guardrails to protect consumers' health, OTC hearing aids could result in hearing loss or other consumer harm. The FDA should mandate age verification processes to protect those under 18 and ensure proper labeling to make clear that OTC hearing aids are only for those with mild to moderate hearing loss."
Joining Attorney General Nessel in sending that letter are the attorneys general of Arizona, Arkansas, Colorado, Connecticut, Delaware, Florida, Georgia, Guam, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Minnesota, Mississippi, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Texas, Utah, Vermont, Virginia, West Virginia, and Wisconsin.
"Establishing a regulated OTC market would bring an influx of competition to an industry currently dominated by a small number of manufacturers, driving down prices and spurring innovation. In doing so, the Proposed Rule would also reduce demand for largely unregulated personal sound amplification products (PSAPs), which are not meant to treat hearing loss but are often misleadingly advertised as a lower-cost substitute for hearing aids. Our residents are increasingly turning to PSAPs simply because they cannot afford hearing aids. The existence of affordable OTC hearing aids would pull those consumers into a regulated market and away from PSAPs which, if not used properly, can be harmful to patient health. We commend the FDA for this much-needed rulemaking," the New Jersey-led comment letter states. "To be sure, establishing a regulated OTC market for hearing aids would direct consumers seeking a low-cost treatment for hearing loss away from PSAPs, which, in itself, goes a long way toward addressing our concerns. But there will still be bad actors who, emboldened by the current lax enforcement, may improperly offer PSAPs as a substitute for hearing aids. Therefore, we urge the FDA to step up enforcement of existing hearing aid regulations against PSAPs manufacturers and retailers who improperly offer these products to treat or compensate for hearing loss."
Joining Attorney General Nessel in sending that letter are the attorneys general of Delaware, the District of Columbia, Illinois, Maryland, Massachusetts, Nevada, New York, and Rhode Island.