AG Press Release: ATTORNEY GENERAL SHIKADA URGES FDA TO Preserve STATE REGULATION OF OTC HEARING AIDS
Posted on January 20, 2022 in Current Department News, Newsroom
HONOLULU – Hawaii Attorney General Holly T. Shikada joined a bipartisan coalition of 42 states and territories calling on the U.S. Food and Drug Administration to become the state authority to enforce its consumer protection laws related to the sale of over-the-counter ( OTC) products to uphold ) hearing aids.
The FDA is currently considering a proposal that would introduce, for the first time, a new category of OTC hearing aids that would allow such devices to be sold directly to consumers without a medical exam or fitting by an audiologist, and are making changes to address the regulatory framework to update for hearing aids.
Currently, all 50 states have licensing requirements for hearing care professionals and many have important protections for hearing aid users, including mandatory warranties and returns and advertising restrictions. Attorneys general warn that regulations currently under FDA review could inadvertently impede or override these key consumer protection agencies, undermining states’ ability to provide safe and affordable access to hearing aids. Attorneys General are asking the FDA to make it clear that its federal rule does not pre-empt this critical state consumer protection.
“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 contains broad language that could be interpreted as effectively repealing it Everyone the federally-pending preemption waivers issued by the FDA since 1980—including those that relate solely to non-prescription hearing aids. Such language could create unnecessary confusion and the potential for unnecessary litigation,” the commentary reads.
“While we support more affordable and accessible hearing aid options, it should not come at the expense of the safety and well-being of the public,” Attorney General Shikada said. “It is critical that the state remains able to regulate hearing care professional licensing requirements so that the people of Hawaii have important safeguards for their hearing aid users.”
The attorneys general are also asking the FDA to strengthen age verification procedures to protect children under 18 and clarify that OTC hearing aids are only suitable for people with mild to moderate hearing loss.
“Additionally, we are concerned about the inadequate mandatory age verification processes and lack of labeling requirements. Without these proper safeguards to protect consumer health, OTC hearing aids could result in hearing loss or other consumer harm. The FDA should mandate age verification procedures to protect individuals under the age of 18 and ensure proper labeling to make it clear that OTC hearing aids are only appropriate for individuals with mild to moderate hearing loss,” the attorneys general said.
The comment writing was led by Connecticut Attorney General William Tong and Ohio Attorney General Dave Yost, followed by Attorney General Shikada and the Attorneys General of Arizona, Arkansas, Colorado, Delaware, Florida, Georgia, Guam, Illinois, Indiana, Iowa, Kansas , Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Texas, Utah, Vermont, Virginia, West Virginia and Wisconsin.
click here to access the letter.
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For more information contact:
Gary H. Yamashiroya
Special Assistant to the Attorney General
Email: [email protected]