30 million or more Americans suffer from hearing loss; and this number is growing, due to the prevalence of age-related hearing loss and the aging of the U.S. population. Hearing loss is a complex medical condition. Available treatments – including the use of hearing aids – mostly aim to make the symptoms of hearing loss better and improve everyday function rather than cure its underlying causes, and may work better for some consumers than others. 67 to 86 percent of adults may benefit from hearing aids but they do not use them because of the price for hearing aids and related services.
On March 20, 2017, The Over-the-Counter Hearing Aid Act of 2017 (S 670) was introduced in the U.S. Senate by Senators Elizabeth Warren (D-Mass), Chuck Grassley (R-Iowa), Maggie Hassan (D-NH), and Johnny Isakson (R-Ga). A similar bill (H.R. 1652) was also introduced in the U.S. House by Representatives Joe Kennedy III (D-Mass) and Marsha Blackburn (R-Tenn). One of the co-sponsors is Representative Collin Peterson (Democrat, Minnesota District 7, which is in the Freedom Resource Center service area).
The reintroduced bipartisan legislation is designed to make hearing aids for those with mild-to-moderate hearing loss available over the counter (OTC), just like reading glasses, which should drive down costs, increase competition, and make it easier for some individuals with certain types of hearing loss, obtain basic hearing aids.
The bill would require the US Food and Drug Administration (FDA) to propose a rule that would establish an OTC hearing aid category for adults with “perceived” mild-to-moderate hearing loss within 3 years of passage of the legislation, and finalize a rule within 180 days after the close of the comment period.
The Act would:
- Makes certain types of hearing aids–those intended to be used by adults to compensate for perceived mild to moderate hearing impairment–available over the counter.
- Removes an unnecessary and burdensome requirement that consumers obtain a medical evaluation or sign a waiver of that examination in order to obtain an OTC hearing aid.
- Requires the FDA to issue regulations containing safety and labeling requirements for this new category of OTC hearing aids.
- Maintains existing safety, labeling, and manufacturing protections and applies them to OTC devices in order to ensure that OTC hearing aids are held to the same high standards as other medical devices.
- Requires the FDA to update its draft guidance on Personal Sound Amplification Products (PSAPs), consumer electronics products that may use similar technology to hearing aids, but are intended for use by individuals with normal hearing.
As with any legislation, there are groups that support and this legislation, and groups that are vocal critics of the bill. At this time the Senate bill has been referred to the Committee on Health, Education, Labor, and Pension; and the House bill has been referred to the Subcommittee on Health.
(image description: a black and white picture of a women that appears to have been taken in the 50’s. The female is wearing a knit suit top with a scarf around her neck and tucked into the suit top. She is hold a straight pipe that widens to a cone shape in her ear, like an old fashioned listening device.)