The National Institute on Deafness and Other Communication Disorders (NIDCD) estimates that 37.5 million Americans report some type of hearing loss. Among adults aged 70 and older, only 30 percent who could benefit from wearing hearing aids have ever used them. The FDA is considering what to do about that.
The FDA Stance on Hearing Aids
The agency recently announced that it is actively examining ways to balance patient safety issues with the need for more rapid advancements in hearing aid technology and better access to the devices across America.
William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, notes: “The FDA recognizes that hearing aids are an important and often underutilized medical device for those with hearing impairment. Additional insight from all stakeholders will help us to better understand how we can overcome the barriers to access and spur the development of devices that compensate for impaired hearing.”
The Reason for Re-evaluation
As it now stands, hearing aids are required to comply with general FDA regulatory controls put in place to ensure the safety and effectiveness of medical devices. However, there is some concern that the regulations currently in place are hampering the pace of innovation and unnecessarily raising the cost of hearing aids.
Based in part on recommendations in a report from the President’s Council of Advisors in Science and Technology (PCAST), the FDA plans to host a public workshop to further explore its role in making hearing aids more accessible and spurring new development in the field of auditory assistive devices.
How Older Adults May Benefit
While the outcome of this evaluation by the FDA is unknown, it seems likely that FDA changes will be good news for older adults suffering from hearing loss. The three most cited obstacles to hearing aid adoption are cost, appearance, and dissatisfaction with current technologies. If FDA changes impact all these areas, it is likely that more with hearing impairment will turn to hearing aids for a solution.
Addressing Cost Issues
In most cases, Medicare does not cover the cost of hearing aids or the exams needed to properly fit them. This presents a major challenge for many older Americans. According to a recent AARP article, the average cost of a mid-level pair of hearing aids is $4,400-$4,500 across the country, making hearing aids prohibitively expensive for many.
The Appearance Issue
There is also a psychological barrier for some who are reluctant to use hearing aids. Many people feel that wearing a hearing aid would detract from their appearance. Advances in hearing aid technology might alleviate this concern to some degree, as manufacturers work to make their devices as unobtrusive as possible.
Eliminating Technological Shortcomings
If the FDA’s exploration results in spurring research and innovation in the industry, it seems probable that technologies will emerge that address pain points for many hearing aid wearers. Advances both in the shape and function of hearing aids could present a persuasive proposition for those on the fence about trying the devices.
What the FDA Now Recommends
For now, the FDA provides some helpful hints and words of caution for those considering hearing aid use. Their checklist for those with hearing impairment includes this advice:
- Before purchasing hearing aids, get an exam from a licensed physician to rule out any medical issues that would require medical or surgical treatment.
- Consider getting advice from an audiologist, who specializes in hearing loss issues and can make recommendations concerning non-medical treatment options for hearing impairment.
- Select your hearing aid according to the manner in which you intend to use it.
- Get help in understanding how to clean and maintain your hearing aids appropriately.
- Look for a manufacturer that offers a trial period or adjustment period.
- Check out the manufacturer warranty.
The FDA’s renewed focus on hearing aids is likely to result in advances in technology that will spur hearing aid use among older Americans and thereby enhance their quality of life. For more information, check out our blog for hearing loss news and other senior home care matters.