You may have heard about a new hearing aid law recently approved to expand access to hearing aids without a prescription. Many of my Memphis patients have asked what this means for them. What is the new hearing aid law? When can I get over-the-counter hearing aids now? Are OTC hearing aids safe and effective?
What Is the New Hearing Aid Law?
According to WhiteHouse.gov, the Executive Order on Promoting Competition in the American Economy includes instructions for the FDA to allow authorized companies to sell hearing aids over the counter (OTC).
OTC means that some people will no longer need a hearing exam, prescription, or professional fitting by an audiologist (like me) to buy a hearing aid.
Is This a Good Thing?
This is intended to reduce the cost of hearing aids so that more people who need hearing aids can get them and promote public health. According to AARP and scientific research, hearing aids can:
- Reduce the risk of falling
- Improve mood and emotional wellbeing
- Enhance brain function if it is declining due to hearing loss
- Decrease the risk of dementia
- Reduce hospital visits and shorten stays
- Keep people connected with those they love
If new hearing aid laws help people get these benefits, it’s a very good thing.
Who Can Get an OTC Hearing Aid?
According to the official statement, OTC hearing aids are intended only for adults over 18 with mild to moderate hearing loss. The US Food and Drug Administration (FDA) decided only to have the rule apply to these individuals based on science.
Why Are Those with Severe Hearing Loss Excluded?
With 25% of people 65 and 74 and over 50% of people over 75 with severe hearing loss, many will need a hearing test, prescription, and professional fitting. Severe hearing loss hearing aids must be personalized to a person’s unique hearing loss profile to work effectively.
Why Are Children Under 18 Excluded?
This is a critical time for language, learning, and social skills. When disrupted, even for a short time due to hearing loss or auditory processing disorder, this can cause significant, long-term struggles. For this reason, those under 18 should always see a professional if they struggle with hearing or processing disorders. Together, we can ensure your child gets the hearing aid that’s best for them.
How Can This Benefit Those Who Are Excluded?
This will probably increase competition in the hearing aid industry. This may drive hearing aid costs down and spark new innovations in an already technologically-advanced hearing aid industry. This will likely also increase awareness about the importance of hearing aids. It’s my hope that more people will get the help they need to hear.
Are Over-the-counter Hearing Aids Available Now?
Beginning on OCTOBER 17, 2022, OTC hearing aids became available under this Executive Order. Several retailers can carry them in the Memphis area, including:
- Best Buy
Are Over-the-Counter Hearing Aids FDA Approved?
The FDA does not approve hearing aids or most medical devices, for that matter. FDA approval means that a company has done rigorous clinical testing to show that the benefits of something outweigh the risks. The FDA reviews these studies and then gives FDA approval if the company proves its case.
Instead, the FDA is giving “FDA clearance” to hearing aid companies that have filed for “510(k) clearance” to market their hearing aids. This is a less rigorous review process and is not as closely monitored.
This doesn’t mean OTC hearing aids can’t be safe and effective. But it does mean that if the person has any concerns about the safety and effectiveness of hearing aids, they are much better off coming to see me for a formal hearing test and proper fitting so I can help them hear at their best. You can schedule an appointment here.