Back in October, the President’s Council on Science and Technology (PCAST) approved a report of recommendations that addresses the FDA, audiologists, and the Federal Trade Commission with specific steps they believe will encourage more consumer-friendly hearing product regulations. The recommendations specifically address the increasing knowledge that mild age-related hearing loss, which affects 30 million Americans, can be successfully self-monitored and treated.  Here is an outline of the four recommendations. The American Academy of Audiology expects the full report will be available in early November.

  • PCAST is encouraging the FDA to create a separate category for over-the-counter hearing aids and hearing tests to detect and treat mild hearing loss. This category would be exempt from FDA oversight, and instead be held to similar standards as those for consumer electronics.

For those with medical insurance that doesn’t fully cover an exam with an audiologist or the cost of hearing aids, this move could significantly cut the cost of out-of-pocket hearing-related health expenses.

  • PCAST’s report asks the FDA to withdraw “draft guidance” of PSAPs (personal sound amplification products).

Again, this would reduce the cost and streamline the process of obtaining these devices over-the-counter. 

  • The report recommends audiologists should be required to provide their patients with a free copy of their hearing test results, the same standard practiced by optometrists.

This would allow patients the choice to shop for the best value in hearing aid devices rather than being required to use a particular supplier.

  • The PCAST report is advising the Federal Trade Commission to authorize hearing aid vendors to receive electronic copies of patients’ hearing results, without an additional charge to the patient.

This coordinates with the previous point to provide no-hassle, affordable hearing aid devices from whichever authorized supplier the patient chooses.

So far there has been no response from the agencies, who are not required to make any changes at this point (although they have the authority, especially if directed by Congress). The American Academy of Audiology intends to look at the full report in greater detail when it becomes available before determining how they will respond. At the very least, this report shows increasing awareness of the need to making hearing loss treatment affordable for everyone.