"The American Speech-Language-Hearing Association (ASHA) has concerns regarding the Over-the-Counter Hearing Aid Act, which was introduced in the U.S. Senate this week by Senators Elizabeth Warren (D-MA) and Chuck Grassley (R-IA), and Representatives Marsha Blackburn (R-TN) and Joseph Kennedy
(D-MA). ASHA supports greater access to hearing health care services, but believes the bill goes too far in expanding "direct to consumer" hearing aids to individuals with moderate hearing loss.
"We are encouraged by the willingness of the Senators and Representatives to work with ASHA to include measures that will advance safe and effective hearing health for many Americans.
"These measures include specific Food and Drug Administration (FDA) regulations of over-the-counter (OTC) hearing aids that (1) establish or adopt output limits that are appropriate for the devices, (2) designate labeling requirements that cover how consumers may report adverse events using
the devices, and (3) specify conditions or contraindications for which use is not advised.
"As the legislative process continues, ASHA looks forward to working with the Congressional offices involved on the aspects of this bill that are cause for concern. Those include the absence of any language specifying that OTC devices are for mild hearing loss only, the need for
protections in the bill that ensure that children with hearing issues are not the users of OTCs, and the requirement for the FDA to collect data on adverse events and contraindications.
"ASHA remains committed to working closely with legislators on measures that provide the public with appropriate, effective, and safe hearing health care."
American Speech-Language-Hearing Association (ASHA)
ASHA is the national professional, scientific, and credentialing association for 191,500 members and affiliates who are audiologists; speech-language pathologists; speech, language, and hearing scientists; audiology and speech-language pathology support personnel; and students. Audiologists specialize
in preventing and assessing hearing and balance disorders as well as providing audiologic treatment, including hearing aids. Speech-language pathologists identify, assess, and treat speech and language problems, including swallowing disorders.