On July 16, Academy President Angela Shoup, PhD, sent a letter to the U.S. Secretary of Health and Human Services (HHS), the Honorable Xavier Becerra, to express the Academy’s concerns about the Administration’s oversimplification of hearing loss and treatment in the advancement of over-the-counter (OTC) devices, as reflected in President Biden’s recent Executive Order and accompanying fact sheet.
The Academy’s letter urges the HHS to recognize the critical role of the audiologist in helping consumers to navigate the various options and determine the type of device that would be most appropriate to treat their diagnosed degree of hearing loss.
The Academy was pleased to receive a response to our letter from the FDA that recognizes the critical role of the audiologist as well as the complex nature of hearing loss. Below is a relevant excerpt regarding acknowledgment of the role of the audiologist.
Alternatively, you may review the full reply.
“We note that the fact sheet stated that experts agreed that a medical evaluation was not necessary (for OTC) linked to a report by the National Academies of Sciences, Engineering and Medicine. We do not, however, interpret this statement as dismissing the role of the audiologist or to mean that audiologists or other hearing Health professionals should have no role in the selection and use of OTC hearing aids. Moreover, we recognize that hearing loss is more complex than loss of volume and that users may derive more satisfaction from the use of an OTC hearing aid under the direction of a hearing health professional, such as an audiologist.”
A growing body of evidence demonstrates the connection between health outcomes to income, education, nutrition, housing, environmental exposures, and other social circumstances. Similarly, studies have shown that interventions addressing SDOH can improve health outcomes and reduce health care costs. In response, the Biden-Harris Administration has released a playbook outlining new or strengthened initiatives that agencies…
The U.S. Department of Health and Human Services Office of Inspector General (OIG) posted on October 25, 2023 Advisory Opinion No. 23-08, in which OIG rejected a proposed arrangement from a cochlear implant device manufacturer (the requestor) that would provide a free hearing aid to certain qualified patients who received a cochlear implant. OIG concluded the…
Representatives Bilirakis and Cartwright Introduce the Medicare Audiology Access Improvement Act of 2023 (H.R. 6445)
On November 17, 2023, Representative Gus Bilirakis (R-FL) and Matt Cartwright (D-PA) introduced the Medicare Audiology Access improvement Act (H.R. 6445). This legislation is also co-sponsored by Representatives Johnson (R-OH), Shakowsky (D-IL), Mace (R-SC), Blunt Rochester (D-DE), Fitzpatrick (R-PA), Trone (D-MD), Webster (R-FL), Cohen (D-TN), LaMalfa (R-CA), Grijalva (D-AZ), Foster (D-IL) and Pocan (D-WI). Senators Elizabeth…