To the FDA Regarding OTC Device Sales
The FDA should designate a new, distinct class of “basic” hearing aids intended to address mild to moderate ARHL to be sold OTC.	For “basic” aids, consultation with a credentialed dispenser should not be required, and federal regulation should preempt any state laws requiring such consultation.
	OTC devices could be labeled with appropriate warnings about red flag symptoms of serious underlying conditions.
	The FDA should approve OTC tests that allow consumers to self-fit and adjust devices.
The FDA should withdraw its draft guidance on PSAPs.	PSAPs should be understood as devices for discretionary consumer use, which may be helpful to people with hearing loss as well as those with normal hearing who have difficulty understanding speech in some situations.
To the FTC Regarding Non-OTC Device Sales
Analogous to the “eyeglass rule,” audiologists and hearing aid dispensers must provide consumers with copies of hearing tests and programmable audio profiles at no additional cost.	Clinicians must provide medical information that the consumer can take to other dispensers or vendors to configure a hearing aid for the consumer.
	Clinicians must provide tests and fittings without requiring consumers to purchase additional goods and services.
Analogous to the “contact lens rule,” the FTC should define a process whereby (in-state and out-of-state) hearing aid and PSAP vendors can get a copy of the consumer’s hearing test and programmable audio file from the clinician who performed the test at no additional cost.	Clinicians must provide medical information that will allow other vendors to configure a hearing aid for the consumer.

Note. FDA = Food and Drug Administration; FTC = Federal Trade Commission; OTC = over-the-counter; PSAP = personal sound amplification product.

Source. President’s Council of Advisors on Science and Technology.¹¹