Senate’s OTC Hearing Aid Act: Expanding Access to Hearable Technology and Increasing Provider Communications with Patients who are Deaf or Live with Hearing Loss

By Lorianne Sainsbury-Wong posted Thu August 31,2017 11:34 PM


With this month’s U.S. Senate passage of the Over-the-Counter Hearing Aid Act, pursuant to the Food and Drug Administration (FDA) Reauthorization Act of 2017 (S. 934; H.R. 2430), legislators validate what consumers have long acknowledged -- the increased frequency of hearing loss and its significant impact on an individual’s safety, health, and quality of life, including access to medical care. Section 520 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j) was amended, effective 8/18/17, to regulate OTC hearing aids and permit direct access by consumers without prescription or supervision by a licensed person. See Sec. 709 of the Act (describing the regulation of OTC hearing aids.)

Although permitting manufacturers to sell FDA-approved hearing aids to consumers is a considerable measure, not all individuals who are Deaf or live with hearing loss benefit from these devices. Individuals may require alternative or additional methods of communication, particularly under certain scenarios, such as provider/patient relationships which discuss medical conditions, medications, and related data. See 28 C.F.R. § 36.303(c)(1)(ii) (stating that the auxiliary aid or service varies with “the nature, length, and complexity of the communication involved; and the context in which the communication is taking place.”) Providers must maintain ADA obligations to make available effective measures by which Deaf and hard of hearing patients can receive and/or convey medical information. 

Hearing aids are not a panacea. The ADA requires qualified interpreters, computer-aided transcription services, assistive listening devices, and other accessible communication methods. See 28 C.F.R. § 303(b)(1). Provider operational and compliance standards, therefore, must ensure effective communications to promote comprehensive access to services and the rendering of appropriate medical care. Patients who are deaf or live with hearing loss present unique circumstances, and providers should consult with their patients to assess which auxiliary tools and services would best enable effective communications.

Communications with patients who are Deaf or hard of hearing must be on par with communications with patients who have no disabilities. See 42 U.S.C. § 12182(a) (stating that no person shall be discriminated against on the basis of disability in the full and equal enjoyment of services, facilities, or accommodations of any place of public accommodation). Monitoring and ensuring that providers make auxiliary aids and services available promotes effective communications and protects patients against healthcare inequities. 

As a result of this meaningful Congressional legislation, industry leaders such as Apple, Samsung or Android, for example, may meet rising consumer demands for auditory supports with the features and benefits of “hearable” technology. Such developments not only offer consumers more flexibility in addressing their communication access needs but also may assist in meeting certain obligations by providers who treat Deaf or heard of hearing patients that benefit from these scientific advancements.

Lorianne M. Sainsbury-Wong | MBA Health Law Section Council, Ex-Chairperson, and MBA Civil Litigation Section Council Member 
Caveat: The opinions expressed in this blog are my own and do not necessarily reflect the views of my pro bono counsel work at the Massachusetts Commission for the Deaf and Hard of Hearing​