The new Lexie B1 Hearing Aids will be Powered by Bose, allowing wearers to fit, program, and control their hearing aids — without a doctor visit, hearing test, or prescription, according to the companies' announcement.
A recent article appearing on the “NBC News” website by Phil Galewitz with “Kaiser Health News,” discusses the expansion of over-the-counter hearing devices currently on the market for people with mild-to-moderate hearing loss, in the absence of FDA regulations governing the 2017 “Over-the-Counter Hearing Aid Law.”
According to a “CNET” article, the feature—which Apple debuted at WWDC 2019—is said to detect loud environments and warn the user that they may damage their hearing.
The FDA has concluded that the Bose Hearing Aid should be classified as a Class II device under the generic name “self-fitting air-conduction hearing aid,” according to an October 5 letter from the Agency. Accordingly, Bose is free to market the device immediately subject to general provisions and special controls required by FDA. Subsequent applications for a self-fitting hearing aid will need to undergo premarket notification requirements, according to the Agency.
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In a conversation with Bose Hearing leaders this week, it became clear that Bose would be borrowing some aspects of their Hearphone technology but not using it as the Bose Hearing Aid. The company views the de novo application as being primarily focused on direct-to-consumer (DTC) distribution, although they do have an interest in the professional channel, and the product is still some ways from becoming available to consumers.
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The center of conversation at this year’s ADA Convention was what impact OTC hearing devices would have on the market, their pros and cons, and how best to prepare a practice for changes in the wake of the OTC Hearing Aid Act of 2017.
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The June 9 Dissemination Meeting featured a wide menu of possible regulations for a new OTC category of hearing devices, and the meeting concentrated on safety and quality control, as well as packaging and labeling requirements. The NASEM meeting’s proposals are not part of the FDA’s formal rule-making process, but they could serve as a starting point for considerations by FDA and discussions with stakeholders in hearing hearing healthcare when formulating a possible new OTC hearing device category.
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In an effort to make certain types of hearing aids more accessible and affordable, US Senator Susan Collins (R-ME), Chairman of the Senate Aging Committee, co-sponsored the Over-the-Counter Hearing Aid Act of 2017, the senator’s office announced. This bipartisan bill was introduced by Senators Elizabeth Warren (D-MA) and Charles Grassley (R-IA).
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