HEN Writes Letter to FDA on Needed Improvements to Proposed Over-the-Counter Hearing Aid Rule

February 8, 2022

Click here to view or download the full letter.

Janet Woodcock, M.D.
Acting Commissioner
Food and Drug Administration
10903 New Hampshire Ave,
Silver Spring, MD 20993

 

Dear Acting Commissioner Woodcock,


Thank you for your hard work and leadership on issues related to healthcare equality and access to care for
Americans during today’s turbulent times.


The Healthcare Equality Network is comprised of leading civil rights organizations and individuals who are
devoted to raising awareness about the disparities in healthcare within our country. We are passionate about
working alongside lawmakers and regulators to close these gaps and provide better access to healthcare
resources to historically underserved communities, particularly Black Americans.


History has shown us that Black Americans have experienced a persistent disparity in our access to and quality
of healthcare options and products. According to the Harvard T. H. Chan School of Public Health, black children
are 5 times more likely to die from asthma compared to their white peers. On average, Black Americans have to
wait about 20 minutes longer for medical attention than their white counterparts, and in critical care situations,
every minute counts. The list goes on and on, which is why our coalition is committed to our mission of
healthcare equality.


We are grateful for the Biden administration’s effort in attempting to make hearing aids more accessible and
affordable to Americans suffering from hearing loss through your proposed rule on over-the-counter (OTC)
hearing aids. Hearing loss is one of the most underreported and prevalent health conditions for older Black
Americans who would benefit from better access to hearing aids. However, as the proposed rule currently
stands, we are concerned that it may exacerbate the historical trend of Black communities getting access to only
lower quality and potentially unsafe health products.


In its current form, the proposed regulations need to be strengthened on a couple of key components. First and
foremost, the FDA proposes an output limit of 120 dB and a gain limit of 25 dB. Similar to other organizations
and stakeholders who have commented on this matter, we are gravely concerned that these proposed volume
levels are harmful for any user with mild-to-moderate hearing loss, who are the target consumers of these
devices. For Black Americans who experience inadequate access to hearing intervention services, including
audiologists who properly diagnose these issues, the current volume limits pose a serious threat to further
damaging their hearing.


In addition to the functions of the hearing aid itself, the FDA’s proposed rule is unclear as to whether these
products need to feature the appropriate package labeling to avoid misleading consumers and patients.
Specifically, the rule does not clearly require product labeling that indicates users should obtain a hearing test to 
confirm the presence and degree of their hearing loss. This is a crucial component in determining if someone
could benefit from an OTC hearing aid, or if they need professional assistance. Furthermore, it does not feature
adequate language to prevent individuals under the age of 18 from purchasing and misusing these devices to
their own detriment. With all the new bells and whistles, a clear distinction between these medical devices and
consumer electronics products is crucial.


Despite the improvements that still need to be made, some Members of Congress are trying to push this
regulation through too quickly without taking the time to bolster safety standards for Americans who will be
using these devices. We are concerned that some of our legislators are prioritizing the needs of consumer
electronic companies
over the well-being of vulnerable American consumers. As a leading advocate for
healthcare equality for Black Americans, we believe that finalizing the rule without addressing these ambiguities
will have disproportionate consequences for our underserved communities.


The COVID-19 pandemic has exposed the systematic faults and flaws in our healthcare system that the Biden
administration has promised to tackle, and we are appreciative of your efforts to address these challenging
issues. By improving these key aspects of regulating OTC hearing devices for the safety of American consumers
and patients, the FDA can take another step in the right direction to make healthcare in this country more
accessible and safer for all.


Thank you for your thoughtful consideration.


Sincerely,


Congressman Ed Towns


The Healthcare Equality Network


The Frederick Douglass Foundation


Southern Christian Leadership Conference


Dr. Benjamin F. Chavis, Jr.


Dr. Julianne Malveaux


 CC: Congressional Black Caucus


Rep. Alma Adams
Rep. Colin Allred
Rep. Karen Bass
Rep. Joyce Beatty, Chair
Rep. Sanford Bishop
Rep. Lisa Blunt Rochester
Rep. Cory Booker
Rep. Jamaal Bowman
Rep. Anthony Brown
Rep. Shontel Brown
Rep. Cori Bush
Rep. George Butterfield
Rep. André Carson
Rep. Troy Carter
Rep. Robin Kelly
Rep. Brenda Lawrence
Rep. Alfred Lawson
Rep. Barbara Lee
Rep. Lucia McBath
Rep. A. Donald McEachin
Rep. Gregory Meeks
Rep. Kweisi Mfume
Rep. Gwendolynne Moore
Rep. Joseph Neguse
Rep. Eleanor Norton
Rep. Ilhan Omar
Rep. Donald Payne
Rep. Stacey Plaskett
Rep. Yvette Clarke
Rep. Emanuel Cleaver
Rep. James Clyburn
Rep. Danny Davis
Rep. Antonio Delgado
Rep. Valdez Demings
Rep. Dwight Evans
Rep. Al Green
Rep. Jahana Hayes
Rep. Steven Horsford
Rep. Sheila Jackson Lee
Rep. Hakeem Jeffries
Rep. Eddie Johnson
Rep. Hank Johnson
Rep. Mondaire Jones
Rep. Ayanna Pressley
Rep. Bobby Rush
Rep. David Scott
Rep. Robert Scott
Rep. Terrycina Sewell
Rep. Marilyn Strickland
Rep. Bennie Thompson
Rep. Ritchie Torres
Rep. Lauren Underwood
Rep. Marc Veasey
Rep. Raphael Warnock
Rep. Maxine Waters
Rep. Bonnie Watson Coleman
Rep. Nikema Williams
Rep. Frederica Wilson

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