Introduction of OTC Hearing Aid Legislation

December 7, 2016

The Over-the-Counter Hearing Aid Act of 2016 (S.9) has been introduced by Senators Warren (D-MA) and Grassley (R-IA). The legislation would compel the Food and Drug Administration (FDA) to allow for the purchase of over-the-counter (OTC) hearing aids by adults with mild to moderate hearing loss. True to any other OTC model, the bill would allow consumers to self-diagnose both the cause and degree of their hearing loss and to purchase hearing aids absent any professional involvement. The bill mirrors recommendations made by the National Academy of Sciences to allow consumers with mild to moderate hearing loss greater choice and access to hearing aids and services. View the full text of S.9.

ASHA opposes S.9 and believes that current federal and state requirements related to professional involvement are important consumer safeguards. Additionally, to assist in the positive outcomes of adapting to a hearing aid, audiologists and other hearing health professionals must be involved to determine the nature and severity of hearing loss in order to provide the proper diagnosis, fitting, and follow-up necessary to manage the individual's hearing health care needs. The legislation is also premature—FDA is currently evaluating its hearing aid regulations and should have the opportunity to complete this review without a Congressional mandate.

Although ASHA supports greater access to hearing health care services, the Association believes that it is important for an audiologist to be involved in the diagnosis and selection of hearing aids to ensure that the patient receives the most appropriate care. Additionally, although the legislation is meant to address the hearing health care needs of adults, the legislation contains no safeguards that would preclude a parent from purchasing OTC devices for their children with hearing loss.

With the 114th Congress adjourning this week, no action by ASHA members is currently required. ASHA will monitor the legislation and alert the membership should the bill be reintroduced next year.

For additional information, contact Ingrida Lusis, ASHA's director of federal and political advocacy, at

ASHA Corporate Partners