The Food and Drug Administration(FDA)is developingproposed regulations forover-the-counter (OTC) hearing aid devices. According to the FDA Reauthorization Act of 2017, these deviceswill be available to the consumer through retail outlets and without having to engage an audiologist, either for a pre-purchase hearing evaluation,or fortheselection, fitting or verification of performance ofthe device. While OTC devices have not yet entered the marketplace, this guidance was developedto assist audiologistsin understanding the differences between existing products and OTC devices, to be ready to answer questions about these devices, and possibly to beginto pre-position practicesin anticipation of the availability of OTC devices. This guidance will be updated as the regulations for OTC devices become available.

In the summer of 2017, Congress passed a law that directed the FDA to develop regulations that make OTC hearing aids available to the public. Prior to this, a number of federal agencies, notably the Federal Trade Commission (FTC) and the President’s Council of Advisors on Science and Technology (PCAST), began to review the accessibility and affordability of hearing care in the United States. Simultaneously, the National Academies of Science, Engineering and Medicine (NASEM) also convened a committee to review and report on the status of hearing care delivery in the U.S. The FDA, the FTC, the National Institutes of Health, the Veteran’s Administration, the Department of Defense, and the Hearing Loss Association of America commissioned the NASEM study.
The genesis of these committees and reviews can be traced to three familiar perceptions and one emerging healthcare concept. The first is the perception that the cost of hearing care, and more specifically the cost of hearing aids, prevents some individuals from seeking treatment for hearing loss. Second, many third party payers do not cover hearing aids; including Medicare where hearing aid devices and associated services are statutorily excluded. The third perception is that the geographic distribution of hearing care providers, including audiologists, is such that there are many areas in the U.S. in which individuals cannot readily access hearing care services.
The emerging healthcare concept is that consumers are demanding greater control over their health care, including the desire to “self-direct” their hearing health care. The impetus may be, in part, to control the cost of their health care, but also to control the time and effort expended when engaged with health care providers. While many common chronic medical conditions, e.g. low back pain, are being “treated” with over-the-counter remedies, there has been no such option for the treatment of hearing loss. This emerging concept could conceivably include alternatives that allowed patients to “treat” their hearing loss without having to see an audiologist, otolaryngologist, or dispenser.
These themes led to several agencies recommending consumer access over-the-counter hearing care devices without the necessity to engage the professional. These recommendations were based, in part, on both emerging technologies (e.g. smartphone apps, hearables, etc.) that could provide hearing benefit and the perception that an ever-increasing technologically savvy population might have the capability to fit and program hearing care devices without the assistance of an audiologist.
The OTC law passed by Congress (S934: FDA Reauthorization Act of 2017) defines an OTC device as one that: “(A) uses the same fundamental scientific technology as air conduction hearing aids (as defined in section 874.3300 of title 21, Code of Federal Regulations) (or any successor regulation) or wireless air conduction hearing aids (as defined in section 874.3305 of title 21, Code of Federal Regulations) (or any successor regulation); (B) is intended to be used by adults over the age of 18 to compensate for perceived mild to moderate hearing impairment; (C) through tools, tests, or software, allows the user to control the over-the-counter hearing aid and customize it to the user’s hearing needs; (D) may— (i) use wireless technology; or (ii) include tests for self-assessment of hearing loss; and (E) is available over-the-counter, without the supervision, prescription, or other order, involvement, or intervention of a licensed person, to consumers through in-person transactions, by mail, or online.” This law mandates that the FDA develop and publish rules no later than 3 years after the enactment of the law. The final version of the law, signed by President Trump on August 18, 2017, specifically notes the following: “The Secretary of Health and Human Services … not later than 3 years after the date of enactment of this Act, shall promulgate proposed regulations to establish a category of overthe-counter hearing aids, as defined in subsection (q) of section 520 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j) as amended by subsection (a), and, not later than 180 days after the date on which the public comment period on the proposed regulations closes, shall issue such final regulations.” The FDA has begun the process of collecting information and data, including input from professional organizations, federal agencies, and consumer groups and could publish proposed rules anytime within the next three years. Included in the proposed rules will be the time frame for the FDA to receive feedback from the public on the proposed rules. During this time, organizations, agencies, or individuals can provide comments, suggest modifications, or provide different options for the proposed rules. It is also possible that the FDA will hold a public hearing at which time the oral testimony can be provided on the proposed regulations. At the close of the comment period, the FDA will evaluate any oral or written testimony and determine whether any changes in the proposed rules are necessary. Within six months (180 days) of the close of the comment period, final rules will be published, along with a date of enactment.

This document reviews devices and technologies currently available for consumers and patients. The options presented within this document do not include surgically implantable devices (e.g. cochlear implants, middle ear implants, etc.). As of now, OTC devices do not exist and therefore their form, function, cost, performance characteristics, or impact on audiology practices is speculative.
Hearing Aid: FDA regulations define a hearing aid as “any wearable instrument or device designed for, offered for the purpose of, or represented as aiding persons with or compensating for, impaired hearing” (21 CFR 801.420). Hearing aids are regulated by the FDA as Class I or Class II medical devices and are only available from licensed providers. Hearing aids may be recommended for individuals with mild to profound hearing loss and can be customized by the provider.
Personal Sound Amplification Products (PSAP): PSAPs are over-the-counter, wearable electronic devices that are designed to accentuate listening in certain environments (not full-time use). They are generally designed to provide some modest amplification of environmental sounds but because they are not regulated by the FDA, they cannot be marketed as devices that help individuals with hearing loss. The FDA suggests that examples of situations in which PSAPs typically are used include hunting (listening for prey), bird watching, listening to lectures with a distant speaker, and listening to soft sounds that would be difficult for normal hearing individuals to hear (e.g., distant conversations) (FDA Draft Guidance, 2013). PSAPs are currently available for purchase by the consumer at a variety of retail outlets, including through on-line retailers. Audiologists can sell PSAPs.
Assistive listening devices (ALD), Assistive listening systems (ALS), Alerting devices: Broadly, a category of devices that assist the person with hearing loss manage specific listening environments or situations in which conventional devices are inadequate or inappropriate. ALDs or ALSs can be used at work, home, places of employment or places of entertainment, and can be used to improve the signal-to-noise ratio, counteract the effect of distance, or minimize the effect of poor acoustics (e.g. reverberation.) These devices may be for personal use or for groups (wide area). Alerting devices typically utilize light, intense sound or vibration to connect or signal the person with hearing loss about events in their environment, and can be connected to phones, lights, doorbells, smoke alarms, etc. The FDA does not regulate ALDs, ALS, or alerting devices, although some devices, such as captioned telephones, may have to comply with FCC regulations. These devices can be purchased through retail outlets, on-line, and audiology practices. In some circumstances, these devices are available for reduced cost through government agencies.
Wireless hearing aid accessories: There are numerous accessories available today that are designed to supplement a hearing aid, enhance communication, or use alternative means of communicating. Accessories include devices that allow the listener to directly stream information from a phone or other personal listening device (e.g., tablet, computer, e-reader) as well as remote or lapel microphones that help the listener to hear over long distances (e.g., in Copyright 2018. American Academy of Audiology. classrooms, conference rooms, and lecture halls). Hearing aid accessories are generally purchased through audiology practices, but are also available through retail outlets.
Hearables: A hearable is any ear-level device designed to supplement and enhance a listening experience, or that includes features such as monitoring vital signs (e.g. heart rate, body temperature, blood oxygen levels, etc.), activity tracking (e.g. steps, calories burned, etc.), augmented hearing (allows users to filter out or enhance specific sounds), music streaming, language translation, or improved face-to-face communication.

Copyright 2018. American Academy of Audiology.