AG Nessel Urges FDA to Enforce OTC Hearing Aid Regulations – CBS Detroit
Tracy J. Chappelle
3 min read
(CBS DETROIT) – Michigan Attorney General Dana Nessel has joined efforts by several states to urge the Food and Drug Administration to enforce consumer protection laws regarding the sale of over-the-counter hearing aids.
The FDA is currently considering approval of a new class of over-the-counter hearing aids that would be sold directly to consumers without a medical exam or fitting by an audiologist.
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“This proposed rule will allow for more affordable and accessible hearing aids, but the FDA must ensure that any action taken preserves states’ ability to protect consumers,” Nessel said. “It is imperative that federal regulations not prejudge safeguards already in place.”
Nessel joined two multi-state letters, one led by the states of Connecticut and Ohio, and the other led by the state of New Jersey, to help ensure consumer protection as the FDA reviews this proposition.
“While the FDA’s proposed rule provides consumers with much-needed relief in the form of more affordable and accessible hearing aids, it could have unintended negative consequences for our constituents. The proposed rule includes broad language that could be interpreted to repeal virtually all state-requested preemptive exemptions issued by the FDA since 1980 — even those related exclusively to non-OTC hearing aids. Such language could create unnecessary confusion and the potential for unnecessary litigation,” the Connecticut-Ohio-led comment letter states. “Additionally, we are concerned about inadequate age verification processes and deficient labeling requirements. Without these appropriate safeguards to protect consumer health, over-the-counter hearing aids could lead to hearing loss or other harm to consumers.The FDA should enforce age verification processes to protect those under 18 and ensure proper labeling to clearly indicate that over-the-counter hearing aids are only for use by people with hearing impairment. mild to moderate hearing loss.
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For a full copy of the letter led by Connecticut and Ohio, visit here.
“Establishing a regulated OTC market would bring an influx of competition into 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 intended to treat hearing loss but are often misrepresented as a cheaper 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 draw these consumers into a regulated market and away from PSAPs which, if not used correctly, can be harmful to patient health. We commend the FDA for this much-needed regulation,” the New Jersey-led comment letter reads. “Certainly establishing a regulated OTC market for hearing aids would drive away consumers seeking inexpensive treatment for PSAP hearing loss, which in itself goes a long way to addressing our concerns. . But there will always be bad actors who, emboldened by today’s lax enforcement, may falsely offer PSAPs as a substitute for hearing aids. Therefore, we urge the FDA to strengthen enforcement of existing hearing aid regulations against manufacturers and retailers of PSAPs who falsely offer these products to treat or compensate for hearing loss.
To see a full copy of the New Jersey-led letter, visit here.
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