Hearing aids without a prescription or an exam? The FDA takes big step toward making that happen.

[BumRushDaShow]

23. I had posted the portion of a 2017 law upthread

(that was ignored for 4 years) that authorized this - https://www.democraticunderground.com/?com=view_post&forum=1014&pid=2815201

H.R.2430 - FDA Reauthorization Act of 2017

and that included the directive to work on and issue rules on OTC hearing aids. It was signed by TFG in August 2017, and promptly ignored for the next 4 years.

Here is that provision (from the above link) -

(Sec. 709) The FDA must categorize certain hearing aids as over-the-counter hearing aids and issue regulations regarding those hearing aids. The regulations for over-the-counter hearing aids must: (1) provide reasonable assurances of safety and efficacy; (2) establish output limits and labeling requirements; and (3) describe requirements for the sale of hearing aids in-person, by mail, or online, without a prescription. The FDA must determine whether premarket notification is required for over-the-counter hearing aids to provide reasonable assurance of safety and effectiveness.

State and local governments may not establish or continue in effect requirements specifically applicable to hearing products that are not identical to FDA requirements and that restrict or interfere with the servicing or sale of over-the-counter hearing aids.

The FDA must update and finalize its draft guidance on hearing products. The guidance must clarify which products are medical devices.

I expect as part of the rule making process, there will be elucidation as to what types of "hearing loss" this would apply to (and it might end up pretty narrow). I also expect at some point (like you see with vaccines), that there will be some type of coordination with CDC to determine the types/levels of hearing loss that might be authorized for OTC products.

For example, CDC has a page here - https://www.cdc.gov/nceh/hearing_loss/what_if_i_already_have_hearing_loss.html

where it's possible such an OTC product is reclassified under a different name (e.g., as a new "Assistive Listening Device" vs a "hearing aid", which could be away to keep the latter as prescription) but could function "in ear". What this then does is set up a way to monitor the manufacturing practices to ensure the safety of that class of devices similar to how other OTC device products are surveilled.

CDC's main site on "hearing" is here (they note that October is "National Protect Your Hearing Month" too) - https://www.cdc.gov/nceh/hearing_loss/default.html

So I think aside from trying to break the price-fixing and near monopoly of a few large companies that are ripping people off, the idea here is to re-look at handling what is probably a common issue and find different ways to address it to improve quality of life.

FDA has distinctions on handling prescription vs OTC medical devices in general - https://www.fda.gov/medical-devices/products-and-medical-procedures/over-counter-otc-medical-devices-considerations-device-manufacturers

(just as an example, one can buy a blood pressure monitor or a pulse oximeter OTC - both being medical devices)