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The U.S. Senate recently passed the Over-the-Counter Hearing Aid Act of 2017. The bill was already passed by the House of Representatives on July 12. With this groundbreaking legislation Congress has sent a message to America that people with hearing loss need – and deserve – more affordable and accessible hearing health care.
The Hearing Loss Association of America (HLAA) has supported the Over-the-Counter Hearing Aid Act since it was introduced in the Senate by Elizabeth Warren (D-MA) and Chuck Grassley (R-IA) in March of this year. The companion House bill was introduced by Representatives Joe Kennedy III (D-MA) and Marsha Blackburn (R-TN). “Senators Warren and Grassley and Representatives Kennedy and Blackburn – among many others – have worked tirelessly to ensure passage of this bill. Their efforts are sure to make a significant difference in the lives of millions of people with hearing loss,” said Barbara Kelley, HLAA executive director.
The Over-the-Counter Hearing Aid Act of 2017 would make certain types of hearing aids available over the counter to adults with mild to moderate hearing loss. In addition, the proposed legislation would require the Food and Drug Administration (FDA) to regulate this new category of OTC hearing aids to ensure they meet the same high standards for safety, consumer labeling and manufacturing protection that all other medical devices must meet. This will give consumers the option to purchase a safe, high-quality FDA-regulated device at lower cost.
Since this new category has not yet been created it is unclear how the devices will be defined. However, they should not be confused with products already on the market called PSAPs (Personal Sound Amplification Products). PSAPs cannot legally be marketed to people with hearing loss as a “hearing aid,” only to those with normal hearing as an amplification device.
Now that the Over-the-Counter Hearing Aid Act of 2017 has been passed by both the House and Senate it will go to the president to sign into law. Once the bill is signed into law it will go to the FDA to begin drafting the rules and regulations. While the FDA has three years to complete that process we are hopeful that it will be done much sooner. HLAA is currently working with the FDA on labeling of OTC products, product safety and consumer protection.
Don’t Wait to Get Your Hearing Checked
If you think you have a hearing loss, do not wait for over-the-counter hearing aids to come to market. First, there will be an extended rulemaking period where anyone can comment after which the FDA has to evaluate and decide on the standards for an OTC device. Second, not everyone will be able to get help from an OTC device. HLAA recommends seeing an audiologist or hearing instrument specialist if you are having trouble on the phone, asking others to repeat, turning up the volume on your television, or showing other warning signs. Untreated hearing loss can cause falls, isolation, depression, anxiety, and it has been shown that there is a link to cognition. Hearing loss should be prevented, screened for, and treated without delay.
The future of hearing health care is changing, allowing people to make informed choices. HLAA will ensure consumers have unbiased and factual information and updates about new products, regulations, and legislation as they develop.
About the Hearing Loss Association of America
The Hearing Loss Association of America (HLAA), founded in 1979, opens the world of communication to people with hearing loss through information, education, support and advocacy. HLAA holds annual conventions (HLAA2018 is in Minneapolis, Minnesota, June 21 – 24), produces Walk4Hearing events in 20 cities, publishes the bimonthly Hearing Loss Magazine, advocates for the rights of people with hearing loss, and has an extensive network of chapters and state organizations across the country. The national headquarters is located at 7910 Woodmont Avenue, Suite 1200, Bethesda, MD 20814. Phone 301.657.2248 or visit hearingloss.org.
For Further Information
More on the hearing device market in the U.S. can be found in a series of reports published by iData Research entitled the U.S. Market Report Suite for Hearing Devices. The suite covers reports on the following markets: traditional hearing aids, bone-anchored hearing aids, cochlear implants, middle ear implants, otoacoustic emission (OAE) analyzers, auditory brainstem response (ABR) analyzers, audiometers, tympanometers, real ear analyzers, otoscopes, hearing aid batteries and personal sounds amplification products (PSAPs).
The iData report series on hearing devices covers the U.S., Mexico, Brazil, Japan, South Korea, Australia and 15 countries in Europe including Austria, Belgium, Denmark, Finland, France, Germany, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, and the United Kingdom. Reports provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. To find out more about hearing device market data or procedure data, register online or email us at [email protected] for a U.S. Market Report Suite for Hearing Devices brochure and synopsis.