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 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 cellphones
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 during its 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.