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> The Food and Drug Administration moved to make hearing aids easier to buy over the counter without a prescription or medical exam But you can already buy hea

> The Food and Drug Administration moved to make hearing aids easier to buy over the counter without a prescription or medical exam But you can already buy hearing aids without a prescription or medical exam. I do mean the United States, and I do mean devices labeled as hearing aids and not personal sound amplification products. See this article from Consumer Reports dated November 11, 2021, where they talk about Direct-to-Consumer Hearing Aids and Self-Fitting Hearing Aids, neither of which require a prescription or medical exam, but are still labeled as Hearing Aids: https://www.consumerreports.org/hearing-aids/your-guide-to-hearing-helpers/ https://www.consumerreports.org/hearing-aids/your-guide-to-h... An example is the Bose SoundControl Hearing Aid that I know for a fact has been available for purchase without a prescription directly from Bose for many months (in the USA only). It's true that a lot of people don't know about the Direct-to-Consumer and Self-Fitting Hearing Aids. But I don't understand what benefit comes from the new FDA rules that didn't already exist. EDIT: It sounds like the FDA could be making it worse. Quoting from the Consumer Reports article above, it says, "FDA-Approved Over-the-Counter Hearing Aids could at first look like some of the Direct-to-Consumer options already available—but they will be subject to additional rules." Why would any manufacturer want to market with additional rules when they're already allowed to sell under the Direct-to-Consumer or Self-Fitting Hearing Aid rules?

mikaraento 4y ago
Before the new OTC regulations, the situation in the US has indeed been confusing in multiple ways. This has lead to consumers mostly perceiving hearing aids as prescription devices and the industry being able to maintain higher prices because of that. On the federal level the FDA has required that buyers provide a medical assessment stating their need for a hearing aid. However, buyers older than 18 have been allowed to waive that requirement. On the state level, many states have had prescription requirements. The FDA has ruled against such state laws several times but many laws have remained on the books. While in theory unenforceable, they have created a lot of FUD for prospective sellers. The industry (audiologists and hearing aid manufacturers) has continuously reinforced the view that prescriptions are needed and in the buyers' interest. Personally, I do think the new OTC regulations make the situation clearer and have the potential to improve products (assuming products become easier for users to configure themselves) and lower prices (as it's not only the audiologist's service buyers have paid for, but bundling of examination+device+followups has allowed higher pricing for the devices as well). (See https://www.audiologypractices.org/state-laws-and-hearing-aid-sales https://www.audiologypractices.org/state-laws-and-hearing-ai... and https://fda.report/media/75418/Regulatory-Requirements-for-Hearing-Aid-Devices-and-Personal-Sound-Amplification-Products-----Guidance-for-Industry-and-FDA-Staff.pdf https://fda.report/media/75418/Regulatory-Requirements-for-H...)
bookofjoe 4y ago
>While Bose is no longer manufacturing and selling SoundControl™ Hearing Aids... https://www.bose.com/en_us/products/headphones/earbuds/soundcontrol-hearing-aids.html https://www.bose.com/en_us/products/headphones/earbuds/sound...
deleted 4y ago
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mikaraento 4y ago

Before the new OTC regulations, the situation in the US has indeed been confusing in multiple ways. This has lead to consumers mostly perceiving hearing aids as prescription devices and the industry being able to maintain higher prices because of that. On the federal level the FDA has required that buyers provide a medical assessment stating their need for a hearing aid. However, buyers older than 18 have been allowed to waive that requirement. On the state level, many states have had prescription requirements. The FDA has ruled against such state laws several times but many laws have remained on the books. While in theory unenforceable, they have created a lot of FUD for prospective sellers. The industry (audiologists and hearing aid manufacturers) has continuously reinforced the view that prescriptions are needed and in the buyers' interest. Personally, I do think the new OTC regulations make the situation clearer and have the potential to improve products (assuming products become easier for users to configure themselves) and lower prices (as it's not only the audiologist's service buyers have paid for, but bundling of examination+device+followups has allowed higher pricing for the devices as well). (See https://www.audiologypractices.org/state-laws-and-hearing-aid-sales https://www.audiologypractices.org/state-laws-and-hearing-ai... and https://fda.report/media/75418/Regulatory-Requirements-for-Hearing-Aid-Devices-and-Personal-Sound-Amplification-Products-----Guidance-for-Industry-and-FDA-Staff.pdf https://fda.report/media/75418/Regulatory-Requirements-for-H...)

bookofjoe 4y ago

>While Bose is no longer manufacturing and selling SoundControl™ Hearing Aids... https://www.bose.com/en_us/products/headphones/earbuds/soundcontrol-hearing-aids.html https://www.bose.com/en_us/products/headphones/earbuds/sound...

deleted 4y ago

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