On August 16th the US Food and Drug Administration finalized its rules for the creation of a new class of over-the-counter (OTC) hearing aids that is designed to make amplification more affordable and accessible to consumers (ages 18+) with mild to moderate hearing loss. Five years in the making, these new rules provide a path for consumers to purchase hearing aids directly from stores or online retailers without the need for a medical exam, prescription, or a fitting by a licensed hearing care provider.
The FDA’s OTC hearing aid rule has taken over 5 years. Original OTC Hearing Aid legislation was first passed by Congress and signed by President Trump in August 2017, and it gave FDA a full 3 years to craft the rules, with a deadline of August 2020. However, Covid-19 consumed the FDA’s resources with an “all-hands-on-deck” response to the pandemic, creating a large backlog of approvals and work for the Agency.
Ultimately, the hope is that OTC hearing aids will get amplification into people’s ears much sooner. Previous studies suggest that consumers wait on average 7-10 years before purchasing a hearing aid. Increasing evidence points to how untreated hearing loss is an expensive and debilitating healthcare problem that increases the risk of dementia, negatively impacts general health, increases falls and injuries, degrades aspects of memory and cognitive function and overall quality of life, places burdens on marital/conjugal relationships, negatively impacts income, and is also linked to a variety of chronic illnesses.
It is hoped this new class of OTC hearing aids will allow people to experience better hearing and communication earlier in the aging process, and to seek help from trained hearing care providers should these new devices not work for them and/or their hearing loss becomes more severe or problematic.
With this news comes the good and the concerns. We have seen the affects of untreated hearing loss as many of our patients have waited years to establish a hearing healthcare plan. Adaptation to amplification and the effect on cognitive processing is a concern. As we would all like to see people address their hearing issues soon, we have several concerns regarding this ruling.
Affordability is repeatedly touted as the cause of consumers not moving forward with amplification. In countries where hearing healthcare is provided at no cost, adaptation of hearing aids is no greater than here. Time will tell. We do, however, offer devices to meet your needs and budget while providing professional care and support.
With this new ruling, the purchase of an OTC device does not require a diagnostic hearing evaluation. It is probable that consumers will purchase an over-the-counter device when medical or surgical intervention would correct the hearing loss. We recommend always getting an evaluation first.
Remember, these devices are intended for individuals with mild hearing loss. We are also concerned that many consumers may purchase an OTC device, not find it beneficial and will think “hearing aids don’t work for me”. They will not seek professional care, but the fact is that the device is not appropriate for that hearing loss, their lifestyle or needs.
For some consumers this is maybe what they need, just like my reading glasses are great for me when I am home reading the newspaper. But my prescription bifocals are what I need at the office when caring for my patients.
Be careful. If you have questions about what is right for you, give Jamie or Diane a call at 704-633-0023 or visit our website: www.hearingsolutionsofnc.com. Jane, Cheryl, and I look forward to seeing you soon.