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 FDA published the Notice of Proposed Rule Making (NPRM) in the Federal Register on October 20, 2021. An open comment (90 days) and reply comment (30 days) period follows, after which the FDA will issue final rules.
After the final rules go into effect, you still need to be an educated consumer: learn all you can about your hearing loss and the device you want before you make that purchase.
See below for HLAA’s comments on the new over-the-counter hearing aid rule and HLAA’s statement on the FDA’s release of proposed rules.
HLAA Promotes Consumer Protection in Comments for New Over-the-Counter Hearing Aid Rule (January 19, 2022)
FDA Releases Proposed Rules for Over-the-Counter Hearing Aids (October 19, 2021)
Press Release: FDA Issues Landmark Proposal to Improve Access to Hearing Aid Technology for Millions of Americans
Related Information from the FDA
HLAA's Recommendations to the FDA
Over-the-Counter Hearing Aids – The Consumer View
Hearing Loss Association of America
The ability to effectively communicate is the foundation for nearly all of our daily life activities. For the 48 million Americans who have hearing loss, affordable and accessible hearing health care services and technology that meet their individual needs are critical.
In 2016, the National Academies of Sciences, Engineering, and Medicine (NASEM) published Hearing Health Care for Adults – Priorities for Providing Access and Affordability.
The NASEM made a clear, evidence-based case that over-the-counter (OTC) hearing devices should be available for adults with mild to moderate hearing loss through its Recommendation #7: Implement a New Food and Drug Administration Category for Over-the-Counter Wearable Hearing Devices. As a result, the Over-the-Counter Hearing Aid Act of 2017 was signed into law as section 709 of the FDA Reauthorization Act of 2017 (the OTC Hearing Aid Act). HLAA welcomed and supported the passage of this legislation.
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. The FDA has up to three years from the time the law is passed to publish 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.
The Hearing Loss Association of America (HLAA) supports a regulated market for OTC hearing devices that are intended for adults with mild to moderate hearing loss and meet performance and labeling criteria to ensure their safety, effectiveness and quality. We believe that OTC hearing devices will provide accessible and affordable hearing health care to millions of people who otherwise might not seek help. Or, for those who have sought help, OTC hearing devices could provide an affordable option.
As a consumer organization, HLAA supports informed consumer choice of quality OTC hearing devices that are affordable, safe, and effective. The devices should also be properly and adequately labeled and described to support consumer education. It is also critical that consumers have recourse should the products fail to deliver as promised. More choice means opening the market to greater competition resulting in innovation. More choice also brings the responsibility of ensuring that consumers are educated so they can make informed choices.
Opening the market to OTC hearing devices has the potential to create opportunities not just for manufacturers of hearing devices, but also for the hearing health care professionals who serve consumers with hearing loss.
HLAA looks forward to seeing a marketplace change that results in hearing health care professionals placing value on the service component of amplification and expanding their practices to include people with hearing loss who need or want assistance with OTC devices, regardless of where the device was purchased.
Safety, Efficacy and Quality
The FDA is responsible for protecting the public health by assuring the safety, effectiveness, quality, and security of human and veterinary drugs, vaccines and other biological products, and medical devices, such as hearing aids and over-the-counter hearing devices.
HLAA has confidence that the FDA will create rules and point to standards that will ensure the safety, efficacy and quality of this new category of hearing devices. Consumers must have assurances that these devices will be safe to use; they will not be the cause of further damage to hearing by having a maximum output of dB SPL limits; and they will not cause physical harm to the ear.
We support FDA rules that will also ensure OTC hearing devices are effective. Individuals with mild to moderate hearing loss have different and highly-individualized listening and amplification (or gain) preferences depending on background environment and listening situation. These variable preferences need to be addressed adequately in terms of device performance to produce an efficacious result for the end user.
The outer box labeling should be in a font large enough to be readable and written in plain language—it should not be overwhelming or too extensive. According to the OTC Hearing Aid Act, labeling should include:
- That the device is intended only for adults 18 and older
- Information on how consumers may report adverse events
- Information on contraindications, conditions or symptoms of medically treatable causes of hearing loss and advisements to consult with a licensed health care practitioner
In addition, HLAA suggests labeling should include the following:
- That the device is for adults with a perceived mild to moderate hearing loss
- Has a clearly-stated return policy
- Indicates whether or not the device has a telecoil
- Indicates whether or not the device has been tested for hearing aid compatibility with cell phones
The inner box labeling and referring websites for the device must have an explanation of red flag warnings that is more extensive and provides more direction for consumers than the outer box. It should also provide more extensive information regarding hearing aid compatibility with phones as well as telecoil information and how a telecoil works with assistive listening systems and phones. The labeling should also have a link to the FDA website on hearing aid compatibility, as well as a link to the FCC fact sheet.
The limitations of the product must be provided, with clear explanation of the potential benefits as well as realistic expectations of the device, specifically about using the device in noise, at a distance, or other difficult listening situations.
Currently when a hearing aid does not work as advertised, most complaints are handled with the hearing health care professional who sold the device, or possibly through the state oversight body.
For OTC devices, returning the device to the seller might not be easy and other steps might not be obvious to consumers. For that reason, the FDA must include in the rules a procedure for recourse should the product not work. As with most retail products, OTC devices should have consumer recourse no matter where the device is purchased. For example, the return policy and how to return it should be clearly stated. It should be easy for consumers to return a device following a 60-day trial period.
The FDA regulations should not be so restrictive or onerous. The regulations should allow for and even anticipate innovation in the field.
Self-fitting of hearing devices is a new development in consumer access to hearing health care. Consumers who are used to being guided through the process of selecting hearing aids as well as those consumers who have shied away from hearing aid purchases need to understand that it is their responsibility to be educated consumers. They need to fully understand the benefits and limitations of the devices available and understand the recourse they have if these devices do not live up to their advertised performance.
In addition, HLAA is already fielding requests for information as to whether or not a device is an FDA-approved hearing aid, an OTC device, a PSAP (Personal Sound Amplification Product), or a device that is being advertised and sold outside FDA rules. The FDA, Federal Trade Commission (FTC), and the National Institute on Deafness and Other Communication Disorders (NIDCD), as well as consumer organizations such as HLAA all have a role to play in unbiased consumer education.
We suggest that the FDA, FTC, NIDCD, and other federal agency websites provide the following information:
- Information about how consumers can determine whether or not a product is a hearing aid, an OTC device, a PSAP, or is a device that has been marketed outside FDA rules. To that end, HLAA suggests that the FDA creates a publicly-available database on their website listing the models of hearing aids and OTC devices available to consumers under FDA rules.
- Basic information regarding how OTC devices are different from hearing aids, how they are similar, and how they work.
- Information how the device can be used with assistive listening devices and systems for a range of use cases, including difficult listening situations such as noisy restaurants and large indoor meeting places.
- Information on how to connect with landline and wireless phones and a link to both the FDA and FCC websites on hearing aid compatibility.
- Information and background information about telecoils and their multiple uses; e.g., phones, wide-area listening situations with a hearing loop, or other assistive listening systems or devices.
- Explanation regarding the device manufacturer’s complaint process and a company contact for complaints.
- Links to the FDA and FTC websites that provide information about filing complaints with those agencies should be included.
- Information about the ability of consumers to exercise their private right of action under any state or federal product liability, tort, warranty, contract or consumer protection law.
- Links to online resources such as FDA, NIDCD, FCC and HLAA.
FDA Report to Congress
The OTC Hearing Aid Act requires that no later than two years after the date the final regulations are issued, the Department of Health and Human Services is to submit a report to Congress analyzing any adverse events relating to over-the-counter hearing devices.
To inform such a report, HLAA suggests that a portion of the FDA and/or the FTC website is devoted to OTC hearing devices with a section for consumer complaints. Should the FDA and/or FTC create such a web page, HLAA will link our site (hearingloss.org) to that page to ensure consumers can provide either agency with direct information about any adverse experiences.
In addition, HLAA urges the FDA to require manufacturers and sellers of OTC devices to report adverse events to the FDA.
HLAA does not endorse any product, service, or any type of technology, including OTC hearing devices, hearing aids or other wearable hearing devices sold over the counter or through hearing care professionals.
However, we see the arrival of OTC hearing devices as having the potential to usher in a new era of more affordable, innovative hearing device options, particularly for those consumers with hearing loss who, for whatever reason, have not explored the benefits that traditional hearing aids can provide. With thoughtful oversight by the FDA, information and education from government agencies such as the FDA and NIDCD, as well as manufacturers, and engagement with HLAA and other consumer-facing organizations, we look forward to a time when everyone who needs hearing technology can find, purchase and benefit from the right solutions for their individual needs.
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.