UnitedHealthcare announced that it is now administering AARP Hearing Solutions, helping “make it easier and more affordable for millions of Americans to purchase prescription and over-the-counter (OTC) hearing aids.”
Starting October 17, Walmart announced that it will offer over the counter (OTC) hearing aids to help its customers “live better and healthier lives at affordable prices they can count on.”
Nuheara has announced a worldwide Trademark License Agreement to develop, manufacture and market its hearing aid products under the leading HP brand trademarks through the end of 2027.
Wireless earbuds and innovative audio solutions were one of the predominant themes of this year’s Consumer Electronics Show (CES) in Las Vegas. Here are HR Editor Karl Strom’s three takeaways from CES2022 regarding innovation and the upcoming OTC hearing aid category.
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GN announced availability of the “first-of-its-kind innovative Jabra Enhance Plus earbuds engineered for hearing enhancement” in the US on February 25.
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Researchers from NAL provide objective measures that characterize the acoustic performance of AirPods Pro headphones. The results suggest that, while differences to traditional hearing aids exist, the device’s Headphone Accommodations provide amplification to help people with mild-to-moderate hearing loss hear sounds more easily and allow them to experience the benefits of amplification.
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“The Over-the-Counter Hearing Aid Act,” passed in 2017, directs the FDA to create a new category for self-fit hearing aids—requiring no intervention from a licensed professional—for people over 18 with mild-to-moderate hearing loss.
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The 114-page rules document published today in the Federal Register covers most aspects related to OTC hearing aid manufacturing, electroacoustic requirements, packaging and labeling, returns, and conditions for sale. In an effort to promote more consistency in the regulations and enforcement of hearing aid manufacturing and distribution, the FDA is also proposing several important changes that could affect the industry and state-wide hearing aid dispensing.
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To ensure patient safety, the proposed rule addresses maximum output limits and includes certain device performance and design requirements, such as distortion control limits, self-generated noise limits, latency limits, frequency bandwidth, as well as a requirement to limit the insertion depth of the device. The proposed rule also includes labeling requirements for OTC hearing aids. As hoped, the FDA also issued an updated draft guidance, “Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products (PSAPs).”
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OTC hearing aids don’t have to be something you dread. You can use it as an opportunity to revolutionize your practice and make changes that work in both your and the consumers’ favor.
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‘New York Times’ Personal Health writer Jane Brody, she discusses how new legislation related to coverage of hearing care coupled with increasingly innovative hearing aid design, may compel greater hearing device adoption among people with untreated hearing loss.
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Though much of the discussion related to hearables has centered around over-the-counter devices designed to help improve hearing or to make connecting to other wireless devices like smartphones easy and convenient, they could also be game-changing in an educational setting, says Rory McGreal, author of an article in “The Conversation” and an “expert in educational technology.”
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GN announced the extension of its Jabra Enhance line of hearing enhancement solutions designed to “help users hear more from life.” GN “brings together the convenience of true wireless earbuds with advanced hearing technology to alleviate unaddressed user needs and enable millions of people to take a first step on their hearing health journey,” according to the company’s announcement.
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Nuheara has engaged National Acoustics Laboratories (NAL) under the terms of a Clinical Trial Agreement (CTA) to assist with conducting clinical trials for obtaining FDA and CE compliance for its hearing devices.
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Bose announced the new SoundControl Hearing Aids — the “first FDA-cleared, direct-to-consumer hearing aid developed for adults with perceived mild-to-moderate hearing loss.”
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California Attorney General Rob Bonta issued a consumer alert warning Californians to exercise caution when purchasing direct-to-consumer hearing products, such as hearing aids, over-the-counter or online.
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In an article discussing the future of hearables, “Forbes” writer Frank Fitzpatrick ponders the future of the market once the FDA releases its guidelines for OTC hearing aids.
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Sycle hosted the webinar, “Over the Counter (OTC) Hearing Aids: Their Impact on the Marketplace,” featuring Kyle Acker (RiseENT), Matt Dearing (My Hearing Centers), Bill Brownie (Eargo), Karl Strom (Hearing Review), and moderated by Sean Shoffstall (Sycle). The webinar is now available for viewing on-demand.
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