Since the passage of the Over-the-Counter Hearing Aid Act of 2017 the Food and Drug Administration (FDA) has been working to create regulations regarding this new category of hearing device. OTC devices specifically for people with hearing loss are not yet on the market. If you are considering purchasing a device that claims to be in this new category, buyer beware. The next step will be a Notice of Proposed Rule Making (NPRM) issued by the FDA, followed by an open comment period and then the final rules. After the final rules are in place, you still need to be an educated consumer: learn all you can about the device before you make that purchase.
What is an Over-the-Counter Hearing Device?
Over-the-counter (OTC) hearing aids (or OTC wearable hearing devices as recommended in the NAS report), are not yet on the market. They will be hearing devices for adults with mild to moderate hearing loss purchased directly by consumers from a retailer or online. OTC hearing aids will be regulated by the Food and Drug Administration (FDA) with clear labeling as to use, safety and efficacy. This will be a new option to allow adults with mild to moderate hearing loss to get affordable and easily accessible hearing aids. The FDA is in the process of drafting the rules and regulations regarding this new category of hearing device.
What are PSAPs?
PSAPs (Personal Sound Amplification Products) are amplification devices available now that are intended only for those with normal hearing. The Food and Drug Administration (FDA) prohibits manufacturers of PSAPs from marketing their products as hearing aids to people with hearing loss. One example of how PSAPS are marketed is for hunters who want to hear deer in the woods. PSAPs should not be confused with OTC devices.
The National Academies of Sciences, Engineering, and Medicine (NAS) published their report Hearing Health Care for Adults: Priorities for Improving Access and Affordability. Recommendation #7 of the report states:
The Food and Drug Administration (FDA) should establish a new category of over-the-counter (OTC) wearable hearing devices. This device classification would be separate from “hearing aids.” OTC wearable hearing devices would be defined as wearable, over-the-counter devices that can assist adults with mild to moderate hearing loss.
Practically every industry has been disrupted with innovative technology. The hearing health care market is no different. We could not have considered OTC hearing wearable devices 20 years ago but innovation is pushing its way into the hearing health care market. Innovation has the potential to create more variety and better products. Competition from new players in the market has the potential to drive down cost for not only OTC hearing aids, but for all hearing aids.
In addition, the trend is toward patient-centered care. The easily-available medical information online allows people to take control of their own health care. The old medical model of the doctor making decisions for patients is long gone in many situations. People with hearing loss should have the tools they need to make informed decisions about their own hearing health.
Why not insurance coverage?
Many HLAA members are asking why aren’t we working on insurance and Medicare coverage for hearing aids? Rest assured, we are! HLAA is in this for the long haul and we need all of you. OTC is one piece of the puzzle with a window of opportunity NOW. HLAA will work toward affordable and accessible hearing health care for everyone. Yes, OTC wearable hearing devices will not help people with more complicated hearing loss. But with the innovation, and broad-based attention given to hearing loss, it could mean lower cost hearing aids for everyone.
Why is HLAA Supporting OTC Hearing Aids?
The NAS has made a clear, evidence-based case that OTC hearing wearable devices should be available for adults with mild to moderate hearing loss. The Over-the-Counter Hearing Aid Act of 2017 was signed into law in August 2017.
An estimated 86 percent of people who would benefit from hearing aids do not get them, primarily because of high cost.
HLAA believes and OTC hearing aids will provide accessible and affordable hearing health care to millions of people who might not otherwise seek help. Or, for those who have sought help, OTC hearing aids could provide an affordable option.
People usually wait seven to ten years before they seek help. By that time, hearing loss has totally disrupted their lives, impacting their communication at work, with their families, their ability to participate in their communities and in activities that give their lives meaning and fulfillment.
We believe that available, affordable and accessible OTC hearing aids will encourage more people to take the first step sooner toward taking charge of their hearing health. HLAA does not endorse any product or service or any type of technology including hearing aids or wearable hearing devices sold over the counter or through hearing care professionals. HLAA does support quality, safe and effective technologies and hearing aids that give consumers affordable choices to make their own decisions.
Some reasons stated in the NAS study on why people don’t get help for their hearing loss are:
- Hearing health care is not affordable; for example, hearing aids are not covered by Medicare and most insurance companies
- Services are difficult to access
- Some people have trouble getting past the stigma of wearing hearing aids, while others don’t know they need hearing aids because their hearing loss is gradual
- Hearing loss is often not screened for or discussed in primary health care visits
People Should Have Choices
People need choices. OTC hearing aids are just one option that should be available to adults with mild to moderate hearing loss.
To make an informed choice, consumers must have the tools they need and a way to compare products. HLAA supports industry standards and labeling that will set baseline performance standards. We also support information about these devices on or in the package about when to seek medical help and about realistic expections. We expect to see FDA regulations and consumer protection and education that will ensure that consumers have the opportunity to compare, purchase, and return these products if necessary.
The FDA has approved an online hearing test to help consumers get a better understanding of their own hearing loss. This is one example of a tool that will help consumers assess their needs and take advantage of OTC hearing aids, if appropriate. Or steer them to seek the help of an audiologist if they choose or if their hearing loss cannot be helped with an OTC product.
What about Audiologists and Hearing Instrument Specialists?
More people seeking to understand and address their hearing loss earlier will benefit both consumers and professionals who fit and sell hearing aids.
HLAA has long supported the gold standard of care which is to seek the services of a hearing health care professional first. Many with severe or profound hearing loss and complicated fittings would be at a loss without the help of their trusted audiologists or hearing instrument specialists.
However, people with mild to moderate hearing loss are by and large currently not seeking treatment from professionals – they are simply ignoring their hearing loss. HLAA believes OTC hearing aids will be the first step many people will take to address their hearing loss. People whose hearing loss declines over time will hopefully get help from a hearing health care professional when they can no longer benefit from an OTC hearing aid or when they want or need more audiological services.
Currently, the cost of a hearing aid is typically “bundled” into the cost of the services needed to provide that hearing aid. So you might receive an audiogram, a hearing aid, follow-up services, even batteries, all at one charge. That works well for some consumers who return repeatedly for services; however, others prefer a pay-as-you-go system, paying only for the services that best fits their needs and lowers the upfront costs. In addition, unbundling would make getting help easier when someone moves to another state and needs to have their hearing aids adjusted or repaired.
Many consumers tell us that they have not been aware that services and devices were bundled together. For that reason, we also support transparency in billing. Some audiology groups support unbundling their prices so people would know the difference between cost of the device and cost of follow-up services. HLAA believes that much needed aural rehabilitation services for adults has lost its value under the current system. We believe that unbundling will make all audiology services, including aural rehabilitation, even more valuable to consumers.
There’s More to Hearing Loss Than Getting a Hearing Aid or Cochlear Implant
Over-the-counter hearing aids and hearing wearable devices are just one piece of affordable and accessible hearing health care. Hearing loss is a primary health concern that must be prevented, screened for and treated.
HLAA continues to work on insurance and Medicare coverage for hearing aids which is more complicated and takes a long time. Medicare coverage for hearing aids and rehab services will take legislation change to a Medicare stature that specifically excludes hearing aids.
The NAS report also substantiates what HLAA has been working for and will continue to work for; such as, adherence to the Americans with Disabilities Act, the Rehabilitation Act, the Fair Housing Act, Air Carriers Access Act, the Telecommunications Act, the Communication and Video Accessibility Act, and other legislation that protects our rights as individuals with disabilities.
We work to ensure better acoustics in buildings, assistive listening systems and CART in public places, health insurance and Medicare coverage for hearing aids and auditory rehabilitation, wider access to information about hearing loss especially for primary care physicians who need to include hearing health care in regular health screenings.
As long as there is a single inaccessible meeting room, workplace, airplane, hospital room, theater, television program, website or video, HLAA will continue to work for people with hearing loss to ensure they get the access they need and is their civil right to have.