Policy Related to Over-the-Counter Hearing Aids

February 14, 2017

Although ASHA continues to maintain that the best model of hearing health care features audiologists and consumers collaborating on treatment options, it recognizes instances where that model can be modified. There may be advantages to making hearing aids directly available to some consumers with mild hearing loss. Less costly over-the-counter (OTC) hearing aids could serve as an early gateway for users with mild hearing loss to explore whether they could eventually adapt to hearing technology without significant financial outlay. It is already the case that consumers with perceived mild hearing loss can seek amplification on their own, without professional involvement, by purchasing unregulated personal sound amplification products or other products and devices that are indirectly marketed for hearing loss.

Consequently, ASHA will support proposed legislation related to OTC hearing aids for mild hearing loss only, given that the following provisions are included in the legislation:

Require the FDA to

  • establish limited gain and output thresholds for these hearing aids;
  • ensure that OTC hearing aids are available for adults only;
  • establish a means for collecting information on consumer safety and other potential complaints;
  • require labeling that strongly recommends seeking audiologic diagnostic and rehabilitative services; and  
  • require labels that provide consumers with warning signs for conditions that require medical treatment.

Ensure that current insurance coverage of hearing aids is not undermined. Currently, some states mandate that insurers, including Medicaid, provide coverage for hearing aids for adults; the U.S. Department of Veterans Affairs and the Federal Employee Health Benefits Plans also provide coverage for hearing aids. Any new OTC model should not be seen as a substitute for hearing aid benefits under third party plans. 

Furthermore, ASHA strongly encourages Senator Chuck Grassley (R-IA) and Senator Elizabeth Warren (D-MA) to take a more holistic approach to access to and affordability of hearing aids. Although we can support the creation of a new OTC hearing aid category for mild hearing loss, we believe that this represents only part of the solution. A parallel effort must be undertaken to ensure the establishment of both public and private insurance coverage for patients with hearing loss who do not benefit from an OTC device. These additional categories of services would include coverage of the professional auditory rehabilitation services of an audiologist that would allow a person with hearing loss to maximize their communication abilities with amplification. Without meaningful coverage of all hearing health care services for all individuals with hearing loss, there is a high probability that these individuals will inappropriately self-prescribe OTC devices and fail to receive appropriate care—thereby, not achieving the sufficient benefit from OTC hearing aids.  

ASHA will work with other stakeholders to encourage the Centers for Medicare & Medicaid Services and private health plans to achieve these goals. We urge Congress to review and develop legislation to address Medicare and Medicaid coverage of audiologic services and hearing aids simultaneously with consideration of a new category of OTC hearing aids.

For more information, contact Ingrida Lusis, ASHA's director of federal and political advocacy, at [email protected].


ASHA Corporate Partners