Over-the-Counter Hearing Aid Act Introduced in U.S. Congress Bipartisan legislation that allows hearing aids to be sold over the counter (OTC) to address mild to moderate hearing loss was introduced in U.S. Congress in March. In the House, Rep. Joseph Kennedy III (D-Mass.) introduced the Over-the-Counter Hearing Aid Act of 2017 (H.R. 1652), co-sponsored by Earl Carter (R-Ga.) ... News in Brief
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News in Brief  |   May 01, 2017
Over-the-Counter Hearing Aid Act Introduced in U.S. Congress
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Hearing Aids, Cochlear Implants & Assistive Technology / News in Brief
News in Brief   |   May 01, 2017
Over-the-Counter Hearing Aid Act Introduced in U.S. Congress
The ASHA Leader, May 2017, Vol. 22, 9. doi:10.1044/leader.NIB3.22052017.9
The ASHA Leader, May 2017, Vol. 22, 9. doi:10.1044/leader.NIB3.22052017.9
Bipartisan legislation that allows hearing aids to be sold over the counter (OTC) to address mild to moderate hearing loss was introduced in U.S. Congress in March.
In the House, Rep. Joseph Kennedy III (D-Mass.) introduced the Over-the-Counter Hearing Aid Act of 2017 (H.R. 1652), co-sponsored by Earl Carter (R-Ga.) and Marsha Blackburn (R-Tenn). The bill was referred to the House Committee on Energy and Commerce.
Sen. Elizabeth Warren (D-Mass.) introduced the same legislation in the Senate (S. 670), co-sponsored by Chuck Grassley (R-Iowa), Maggie Hassan (D-N.H.) and Johnny Isakson (R-Ga.). It was referred to the Committee on Health, Education, Labor and Pensions.
At press time, there had been no votes on the legislation.
Proponents say the new law expands affordable access to hearing health care, which ASHA supports, but ASHA President Gail J. Richard said it “goes too far” in expanding “direct-to-consumer” hearing aids to people with moderate hearing loss.
ASHA is concerned about “the absence of any language specifying that OTC devices are for mild hearing loss only, the need for protections in the bill that ensure that children with hearing issues are not the users of OTCs, and the requirement for the FDA [Food and Drug Administration] to collect data on adverse events and contraindications,” Richard said in a press release when the bills were introduced.
Richard, however, said ASHA appreciates other aspects of the legislation: “We are encouraged by the willingness of the senators and representatives to work with ASHA to include measures that will advance safe and effective hearing health for many Americans,” she says.
These measures include specific FDA regulations of OTC hearing aids that:
  • Establish or adopt output limits that are appropriate for the devices.

  • Designate labeling requirements that cover how consumers may report adverse events using the devices.

  • Specify conditions or contraindications for which use is not advised.

The bill would enact many major recommendations made in recent years by the President’s Council of Advisors on Science and Technology and the National Academy of Sciences, including the removal of a requirement that consumers receive medical evaluation or sign a waiver before buying hearing aids.
2 Comments
May 29, 2017
Carol Letzter
Question
I am curious to know who will be selling these OTC devices? Will they simply be available in big box stores and or pharmacies. Or will they be available for purchase by audiologists so that important questions and concerns of consumers may be answered appropriately.
May 29, 2017
Sarah Peters
Oversight
Hearing aid use is too complicated to trust to a Walmart or Cosco distributer. We can do more damage than good if the relationship between a trained professional and the consumer is not established. Too many hearing aids are in drawers in the adult population and missed diagnosis in children to rely on barely trained promoters of OTC hearing aids for the profit only. I fear this will be like the drug companies promoting consumers to ask for drugs they may not need simply because they have seen an advertisement and their doctor does not know otherwise. Let's think about this issue more thoroughly.
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May 2017
Volume 22, Issue 5