WASHINGTON, DC — Members of the board of the American Academy of Audiology (AAA) conducted meetings last week with the U.S. Food and Drug Administration (FDA), members of Congress, and representatives from the private-payer community. According to an announcement to its membership on October 30th, AAA said its board used the meetings to represent audiology’s interests relative to priority issues, such as over-the-counter (OTC) hearing aids, reimbursement policy, and advocacy.
The organization said its leaders held a productive meeting with FDA representatives regarding the FDA’s timing and perspective on the formal rulemaking process to establish a category of OTC hearing aid devices. According to AAA, information recieved from the FDA, during the meetings included the fact that the FDA does indeed consider OTC hearing aids as medical devices, and “regulate them as such”.
“FDA anticipates that the rulemaking process is likely to take the full three years designated in the OTC legislation.”
Member of the AAA board shared their concerns with the FDA regarding the need to mitigate confusion for consumers regarding OTC hearing devices. The board shared a preliminary list of recommendations during their meeting with FDA representatives, developed by AAA, which included the following seven points regarding OTC hearing aids:
- Labeling for OTC devices should include language that advises the user that better outcomes are achieved when a comprehensive audiological examination is conducted prior to the acquisition of an OTC device.
- Labeling should address utilization of OTC devices, including both hearing aids and/or PSAPs, by individuals under the age of 18. Specific language should be included noting that use of OTC devices by individuals less than 18 years of age should only occur under the direction of a licensed audiologist.
- Labeling of OTC devices should advise consumers to seek an evaluation by an audiologist if they are not receiving satisfactory results with an OTC device.
- Labeling of OTC devices should specify that the output may exceed levels that could cause either additional hearing loss or initial hearing loss in those with normal hearing. Standards for the acoustical characteristics of these devices should be set to limit these risks.
- Labeling of OTC devices should advise consumers to seek an evaluation by an audiologist when they notice any change in their hearing, including temporary changes, as sustained long-term exposure to moderate to high output levels may have a negative effect on hearing.
- The Academy recommends that the FDA regulations related to the sale and purchase of OTC devices specify that OTC devices are medical devices and not consumer electronics.
- The FDA should take steps to mitigate consumer confusion regarding the difference between PSAPs and OTC hearing aid devices.
In the announcement to its members, AAA said that it will continue ongoing dialogue with the FDA, and other relevant stakeholders, as the hearing aid delivery model continues to evolve.
Congress, FDA and OTC Hearing Aids
Members of the AAA board also visited with congressional representatives on a number of issues, including topics such as telehealth, student loan forgiveness, funding for the National Institutes of Health (NIH), and other hearing health related issues impacting consumers and professionals.
Additionally, the board convened a small payer forum consisting of AAA leadership and subject matter experts. The forum participants met with private-payer representatives to discuss reimbursement challenges facing audiologists today, and strategies that can be used address some of these challenges. The board hopes that the forum ultimately leads to the creation of “a more comprehensive framework to address payer-related reimbursement issues”.