FDA approval of over-the-counter hearing aids may seem like good news, but there are some caveats to be aware of.
The premise of this legislation is to provide a “self-care” option for hearing care to consumers, explained Catherine Palmer, PhD, Professor in the Departments of Communication Science & Disorders and Otolaryngology at the University of Pittsburgh, and Director of Audiology for the UPMC Integrated Health System. The language indicates that these devices are for individuals with “perceived mild to moderate hearing loss.” The usage of “perceived” is intentional because no hearing test is required prior to purchasing over-the-counter (OTC) hearing aids (HAs).
“The challenge is that data from the past 50 years indicates that individuals do not accurately self-assess their level of hearing loss,” Dr. Palmer said. People both under and over-estimate their degree of hearing loss. And the FDA rule does not provide a range of gain (amplification) that would be targeted towards people with mild to moderate hearing loss, which would allow consumers to get a sense if they have the correct hearing loss for this type of device. The rule also does not provide any guidelines for self-assessing one’s hearing level.
“Ideally, individuals concerned that they have hearing loss would see an audiologist first to have a hearing assessment,” Dr. Palmer said. This is covered by most insurance, including Medicare. This way, individuals will know what degree of hearing loss they have and if OTC HAs might be a reasonable option.
An audiologist’s evaluation means receiving a comprehensive plan to improve communication and safety; hearing aids and other devices are only one part of this. The primary difference between self-care or OTC HAs and the care pathway that includes a professional is customization, Dr. Palmer said.
This customized plan is more than matching technology to patient needs. It includes customizing the physical and acoustic fit of any devices, along with tailoring instruction in how to use and take care of the devices and providing communication strategies and other rehabilitation that will improve communication. “These measures allow the audiologist to ensure that the device cannot injure the individual’s remaining hearing,” Dr. Palmer said.
If someone purchases OTC HAs without the help of an audiologist, they are at another disadvantage. They have likely been listening through the filter of their hearing loss for an average of seven years before pursuing care, which will result in some challenges in terms of their ability to correctly set the device for optimum benefit.
Additionally, two studies looking at self-fitting have found that many individuals not only “under fit” their hearing losses but also require further assistance from a professional to tune and/or physically fit the devices. So, it makes sense for many reasons to see an audiologist as a first step. If you pursue an OTC HA and need help with its use, do not hesitate to contact an audiologist for assistance.
Beyond the need for an audiologist’s intervention, there are other issues with the FDA ruling. The goal, ostensibly, is to make hearing aids more affordable and easier to purchase for consumers. This will help the 3.4 million Americans who know they have hearing loss but have not pursued care if they are able to surmount the many other barriers like assumptions regarding hearing loss and hearing aids and the stigma that surrounds both. It will not address the 26 million who do not even recognize that they have hearing loss.
Not only that, but the wide range of capabilities in products approved by the FDA may be complicated for consumers to navigate. And even though the goal is to make HAs more affordable, the cost may still be out of reach for many.
“Given that these will be self-fit and the consumer will not know if they receive any benefit from the device until they try it, consumers should make sure that any device they purchase can be returned,” Dr. Palmer cautioned. “The rule from the FDA indicates that manufacturers will need to include the return policy on the label, but the rule does not require that the devices can be returned.”
The FDA outlined many items they plan to list on the outside or inside of the device’s packaging. “So many, in fact, it is hard to know how the manufacturer will accomplish this in a way that is easily understandable to the consumer,” Dr. Palmer said. In addition to whether the device can be returned, this includes what the “red flags” are that warn against self-care and when to seek medical consultation, or that it is best to have a hearing evaluation prior to making any decisions about self-care.
If purchasing OTC HAs, in addition to having a hearing test and verifying that devices can be returned, decide if you are comfortable self-programming the device and using app-based technology if this is required for the device you are considering. The Academy of Audiology has created FAQs for consumers related to OTC HAs. At the earliest, OTC HAs will be available in November 2022, so it will be a while before the manufacturers and options are known.
If you are in Pennsylvania, contact the UPMC Center for Audiology & Hearing Aids to find a clinic nearby. If you are outside the area, the American Academy of Audiology has a helpful link to find an audiologist.