More than 48 million Americans experience some form of hearing loss. However, only one in five people who could benefit from using hearing aids have them. Access and education play two key roles in increasing the adoption of hearing aids. People need to know that they would be good candidates for hearing devices while being able to afford them.
At present, patients who experience hearing loss need a prescription to receive hearing aids. They have to work with hearing doctors (audiologists), receive specialist exams, and get carefully fitted with devices. However, legislators on both sides of the aisle and President Joe Biden are calling on the FDA to approve over-the-counter hearing aid options.
The FDA is getting closer to finalizing its policy, which could significantly improve access to hearing devices. Learn more about what access to OTC hearing devices means and the importance of democratizing hearing solutions.
The fight for OTC hearing aids has been growing for more than five years. The proposal was initially introduced in 2017 and passed in a senate bill. The Over-the-Counter Hearing Aid Act was co-sponsored by Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa) with the goal of creating a class of hearing aids regulated by the FDA that could be purchased directly by consumers.
After this law was passed, the FDA set to work creating guidelines for OTC hearing aids and Congress largely forgot about the legislation. Then the COVID-19 pandemic happened and all of the FDA’s efforts were focused on regulating masks, tests, and vaccines. It wasn’t until just recently that it was able to refocus on guidelines for hearing aids.
In October 2021, the FDA released its proposed guidelines. In the past three months, the rules have been in the finalization process by Congress and other policymakers. As of January 2022, there is no finalized policy, but multiple interest groups are calling on the government to approve a plan so these hearing aids can hit the market.
There are two key drivers that keep people from using hearing aids: the cost of the devices and the ability to see professionals to help them get fitted.
Historically, hearing aids have been prescribed only by medical professionals. If a patient experiences mild to moderate hearing loss, they need to find a hearing specialist, take time to schedule an appointment, pay the office fee, and potentially return for follow-up appointments for fitting, replacements, and check-ups.
These costs add up. The average price for a hearing test is $60 in the United States. This doesn’t include the cost of the office visit, the time a patient spends missing work, childcare costs, and transportation costs.
Limiting hearing aids to prescription coverage also limits competition, according to the FDA. A few companies can create hearing devices and control the market by lobbying doctors. They can work to keep prices inflated, making hearing aids inaccessible to low-income Americans. Today, hearing aids costs can range from $1,000 to $6,000 depending on the technology.
Part of the proposed legislation focuses on the return policies of hearing air manufacturers. David Certner, AARP’s legislative counsel and legislative policy director, told RollCall that hearing aids should have at least a 60-day return policy. This allows people to try out the devices to make sure they provide a good fit and work as promised. Many people avoid investing in hearing aids because they can’t recoup their money if they don’t work properly for their specific needs.
The Hearing Loss Association of America (HLAA) is calling for at least a 45-day return policy so patients can enjoy an adjustment period, saying it can take months for some people to feel comfortable with hearing aids.
Finally, OTC opportunities allow the FDA to greater regulate the hearing device market. Currently, some companies create personal sound amplification products (PSAPs) which aren’t covered under the FDA regulatory guidelines. This is what many people use who can’t handle the cost or time requirements of meeting with an audiologist. Now that the FDA has a section for OTC hearing aids, it can require approval before these devices hit the shelves.
“Patients will obtain no genuine benefit from easier access to hearing aids that are unsafe or ineffective,” says Kate Carr, president of the Hearing Industries Association.
Along with access and price, there are personal reasons why people with hearing loss fail to seek help and invest in devices like hearing aids.
“We know that when people find out they have a hearing loss they take five to seven years before they do something about it,” says Barbara Kelley, the executive director of the HLAA. Stigma is one of the main drivers that keep people from getting treatment – so much so that the HLAA created a whitepaper on the need to address it.
Because hearing loss is often gradual, it is easy to ignore. The HLLA uses the example of saying a restaurant is too noisy to hear conversations or that people mumble too much to hear properly. In these instances, people with hearing loss are placing the problem on something other than their own ears.
Many people aren’t ready to face the reality of hearing loss – including the prospect that it could get worse. By ignoring the problem, they believe that their hearing is fine, rather than declining. For a dramatic example of this, watch The Sound of Metal on Amazon.
By making hearing aids more accessible, more people who want them have access to these devices. This can start conversations about hearing loss and help others overcome their nerves about hearing decline. It reduces the stigma while making the prospect of using hearing aids less intimidating because of the perceived cost and fitting process.
Hearing loss comes in multiple different forms. There are times when sound is completely blocked from getting through the ear canal and times when people have a difficult time processing different sounds in ways they can understand. People with different types of hearing loss (and levels of severity) have different needs. Learn more about hearing disabilities and how you can make your school, workplace, or community organization more hearing accessible.