PCAST Approves Report to Encourage Use of Over-the-Counter Hearing Aids and PSAPS

PCAST Approves Report to Encourage Use of Over-the-Counter Hearing Aids and PSAPS

October 26, 2015 Government Relations News

On Friday, October 23, 2015, the President’s Council of Advisors on Science and Technology (PCAST) voted to approve a  report that recommends significant changes to the way in which older Americans can access hearing care in the United States. These recommendations, if implemented, could have a significant impact on audiology practice and on the delivery of hearing care. These recommendations are designed to address the 30 million Americans who have a slowly progressive, bilateral mild-to-moderate hearing loss and the ability of the consumer to self-diagnose, self-treat, and self-monitor their hearing status.

The four recommendations, as we understand them based on the PCAST Webcast presentation, are summarized as follows:

  1. Encourage the Food and Drug Administration (FDA) to create another class of hearing aids and hearing tests to that can be sold over the counter and online for persons with mild-to-moderate hearing loss typically seen in aging. The FDA should exempt this class of hearing aids from the typical quality regulatory oversight of the agency, and instead adopt standards that are more closely aligned with the consumer electronics industry.
  2. Ask the FDA to withdraw its draft guidance of personal sound amplification products (PSAPs). These devices should be for discretionary use by the consumer and can be used to augment or improve hearing.
  3. Similar to optometrists, audiologists and dispensers should be required to provide a copy of hearing tests results to the consumer to allow them to shop for the best value in devices. These results should be provided at no additional cost to the consumer and must not be conditional upon the purchase of products.
  4. The Federal Trade Commission (FTC) should define a process that would authorize hearing aid vendors (e.g., online) the right and ability to obtain a copy of the hearing test results at no additional cost to the consumer.

The PCAST believes these proposed changes will improve both access and affordability of hearing care in the United States. It must be recognized that these are only recommendations at this time, and not directives to the FDA or FTC to make changes. However, both the FDA and the FTC have the authority to make these changes, particularly upon the direction of the President or upon actions by Congress.

The American Academy of Audiology is obviously concerned about the potential impact of these recommendations on patients, audiologists, and audiology practice. The impact could be profound and fundamentally change the manner in which hearing care is delivered in the United States. The Academy will be seeking opportunities to discuss our concerns with the FDA and the FTC.

In combination with the concurrent review of affordability and access to hearing care by the National Academy of Medicine, it is conceivable that momentum to implement some sort of changes could be developed over the next year. The Academy will be reviewing the PCAST  report, and will develop a strategy to address the recommendations.

Click  here to access the full PCAST report.

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