Legislative Update: Legislation Introduced in DC to Define OTC Hearing Aids


Legislation Introduced in DC to Define OTC Hearing Aids

U.S. Senate Bill S. 670, Over the Counter Hearing Aid Act (2017) was introduced by Senator Elizabeth Warren (D-MA) with current co-sponsors Senators Chuck Grassley (R-IA), Margare W. Hassan (D-NH), and Johnny Isakson (R-GA). There is a companion bill in the U.S. House of Representatives, HR 1652, introduced by Rep. Joseph Kennedy III (D-MA) with co-sponsors Representatives Marsha Blackburn (R-TN) and Earl Buddy Carter (R-GA). The legislation is described as follows:

The term ‘over-the-counter hearing aid’ means a device-
“(A) that uses the same fundamental scientific technology as air conduction hearing aids or wireless air conduction hearing aids
“(B) that is intended to be used by adults over the age of 18 to compensate for perceived mild to moderate hearing impairment;
“(C) that, 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) that may-
“(i) use wireless technology; or
“(ii) include tests for self-assessment of hearing loss; and
“(E) that 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.

The Over-the-Counter (OTC) Hearing Aid Act of 2017 would require the FDA to propose a rule that would establish an OTC hearing aid category for adults with mild/moderate hearing loss and include provisions related to the safety and efficacy of OTC hearing aids, output limits and labeling, as well as a provision that would preempt all state laws that would restrict the sale of OTC hearing aids.

The bill would create a new category of hearing aids, Over the Counter (OTC), for individuals with mild to moderate hearing loss and simultaneously pre-empt State License Laws for audiologists by permitting these hearing aids to be fit without professional services.

Even though State Law restricts the sale of OTC, mail-order, or other forms of hearing aids sales, the proposed legislation would pre-empt the State Law and would eliminate the patient protection currently in our laws. The language is written to pre-empt state law and the pre-emption in the proposed legislation takes precedence over State Law.

The proposed legislation is “intended for adults with perceived mild to moderate hearing loss.’ However, at this time, there is no clear accepted definition of mild to moderate hearing loss or any way to assure that only those with this degree of loss will be eligible to purchase devices.

According to the early textbooks, the original purpose of the hearing test and classification system (mild, moderate, severe) was to classify military veterans for compensation following WWII. The classification system was developed “to establish the amount of hearing loss for compensation purposes, including the determination of the original state of hearing before any service-connected…hearing loss has developed.” (Hearing and Deafness, Silverman and Davis, 1947).

This classification system was not intended to be used to classify a disease state. That is, the foundation of the OTC legislation is based on a notion that if you have a mild or moderate hearing loss you can self-treat and manage but anything more then you must have a disorder that needs to be medically managed.

The foundation of this legislation was from the recommendations of the President’s Council of Advisors on Science and Technology (PCAST) who recommended significant changes to the way in which older Americans can access hearing care in the United States. PCAST encouraged the Food and Drug Administration (FDA) to create another class of hearing aids that can be sold over the counter and online hearing tests for persons with mild-to-moderate hearing loss. The FDA should exempt this class of hearing aids from the typical quality regulatory oversight of the agency, and instead adopt standards that are more closely aligned with the consumer electronics industry. The stated goal was to make hearing aids “more affordable” by eliminating the professional service component associated with purchasing a device. Unfortunately, PCAST and a similar report from the National Academy of Sciences were not convinced of the value of audiology services and only recognized the cost of the products. Since audiologists tended to promote a bundled cost for products, the organizations thought that these costs could be significantly reduced if they were sold directly to consumers without professional involvement.

Perhaps, audiologists have brought this upon themselves by allowing the profession to be commoditized these past years. While promoting the benefits of products and making the products the ‘center of the audiology universe’, consumers came to believe that it didn’t matter where they purchased products (e.g., big box, hospitals, clinics), only that they bought the best product at the most affordable prices. There was little differentiation between the product and professional services.

To confuse the issue even more are the disparate opinions and positions statements of professional organizations. ADA, for example, supports the PCAST recommendation to create a “class of hearing aids for over‐the‐counter sale, without the requirement for consultation with a credentialed dispenser.” They also recommended “these over‐the‐counter (OTC) products be very specifically labeled and include a strong recommendation that a patient seek a comprehensive audiologic evaluation from an audiologist or physician prior to purchasing any device for the treatment of hearing loss, especially if the patient exhibits any of the warning signs of ear disease (tinnitus, dizziness, drainage, sudden hearing loss, asymmetry, foreign body in the ear, cerumen impaction, congenital or traumatic deformity of the ear). ADA also recommends labeling that is largely consistent with the PCAST recommendation that the device is a “non‐surgical, air conduction hearing aid intended to address hearing loss.”

ASHA will support the 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.

The American Academy of Audiology is more cautious in their recommendations. AAA President, Dr. Ian Windmill commented, “Though seemingly well-intentioned, the OTC Hearing Aid Act of 2016 appears to be premature. A legislative approach could be more successful if lawmakers wait until the communities of interest have the opportunity to discuss important next steps for implementation of the NAS report recommendations. We view these discussions as critical in shaping and addressing the solutions that truly address patient needs.” In a press release March 15, 2017, Dr. Windmill and president-elect Dr. Jackie Clark reported meeting with Senate sponsors who appeared willing to work with the Audiology community. They used a recent meeting “to discuss the complex nature of hearing loss and the role of the audiologist in supporting positive patient outcomes with regard to hearing aid devices. They also discussed the importance of labeling requirements that would help to both educate and protect consumers as they make decisions to self-direct their hearing care.”

Is it too late to stop this freight train of OTC products and the pre-emption of State Licensure? Only time will tell but, following the direction of AAA, this legislation can be shaped to the benefit and protection of consumers. Audiologists must explain to their legislators the value of professional services in the fitting of amplification and that the hearing aid is simply a part of the entire treatment plan for individuals with hearing loss. Hearing aids should not be confused with consumer electronics that are designed and sold to enhance the listening experience of consumers and not specifically to manage and treat the sensory deficit of hearing loss. Consumer electronics are not intended to be worn 16 hours per day, 7 days a week like hearing aids. If the intention of the legislature is to make hearing care more affordable and accessible, then the alternative would be to mandate third party coverage and reimbursement for audiologic professional treatment services and provide patients with hearing loss direct access to audiology services. Those would address the accessibility concerns and place the focus of costs where they should be, on audiologic management and treatment.

Your FLAA Board is seeking input from the membership before taking a formal position on the OTC legislation. We welcome and encourage your comments and ideas. If you have any thoughts or comments on this legislation, please feel free to send to Barry Freeman, VP of Professional Affairs, at profaffairs@floridaaudiology.org.