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

[BumRushDaShow]

20. In this case

an actual law was passed (via the annual FDA Reauthorization Act - that generally re-ups the User Fees the agency would be permitted to collect) -

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The FDA must update and finalize its draft guidance on hearing products.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.

CPAPs are a bit more complex (not so much with respect to the electronics, but the indications for use). But I expect the issue of generating "competition" to reduce the cost is probably on the table for any of these types of devices.