Dear friends,

You may have heard recently of the passage of a new classification of over the counter hearing devices by the FDA, but you may be wondering what that is all about.  Here are some quick facts on what those hearing devices are and what that may mean for you.  As always, if you have further questions, please do not hesitate to reach out to us for more information.  We consider patient education to be our most important responsibility as hearing healthcare providers!

What are OTC hearing devices?

The FDA has created a new classification of hearing devices called OTC that can be available without a prescription as soon as October 17, 2022, even without a hearing evaluation. They are not to be confused with prescription hearing devices that are fitted by a professional audiologist or hearing instrument specialist with the proper licensure and credentials, tailored to your exact hearing needs.

Who should consider OTC devices?

Adults 18 or over with perceived mild to moderate hearing loss, perhaps who do not consider themselves ready for prescriptive devices, may be good candidates for OTC devices. Since the devices are self-fitted, do-it-yourselfers who are tech savvy and do not require additional support would be good candidates. If your hearing loss is more severe than a mild to moderate loss, OTC hearing aids may not be good for you. Either way, it is advisable to have an evaluation with a hearing healthcare professional who can assess your hearing and make an appropriate recommendation. Hearing aids for more severe hearing loss or for users younger than age 18 remain prescription devices.

Are there any concerns regarding OTC hearing aids?

YES. Many OTC hearing aids do not require a physical or audiological exam prior to purchasing them. While this certainly increases access to the devices, and perhaps makes them less expensive, the lack of an exam prior to obtaining them could lead to missed medical conditions or diagnoses that could require treatment, and perhaps even improving hearing sensitivity. What if it’s just wax causing your hearing loss?

What’s the difference between an OTC device and a prescriptive hearing aid?

In addition to the regulations for safety put out to govern the different classifications of hearing aids, there are several differences between devices you can purchase over the counter and those that you can obtain from a certified and licensed professional or doctor of audiology. Professionals offer a wide range of technology options to meet an individual’s communication, lifestyle, and financial needs, paired with clinical best practices, verification, support, and years of experience and training to maximize your listening experience. It is definitely not a “one size fits most” experience, but instead, one tailor-made to an individual’s particular needs.

Is the future of audiology in jeopardy with this new OTC ruling?

Absolutely not! In addition to diagnostic testing, there will always be a need for high quality technology options paired with best practices for fitting and white glove service and support, and we are here for that! Additionally, custom, in-the-ear hearing devices, cochlear implants, Lyric hearing devices, tinnitus treatment options, devices for children and those with more severe hearing loss and many more services we offer will continue to be exclusively provided on a prescription basis, and not over the counter. OTC devices will improve access, awareness, and advocacy for people who perhaps otherwise would not have sought treatment, and will hopefully drive more people to seek help for their hearing loss earlier than they would have originally.

Hearing loss significantly affects quality of life for tens of millions of adults in the United States and contributes to high healthcare costs. Untreated hearing loss can lead to isolation, and it has been associated with serious conditions such as depression, anxiety, low self-esteem, dementia, reduced mobility, and falls. Yet only one in four adults who could benefit from hearing aids has ever used them. Making hearing health care more accessible and affordable is a public health priority, especially as the number of older adults in the U.S. continues to grow.

There are a lot of options out there and a lot of confusing information. Where should I start?

You should start with your audiologist! If you suspect you may have a hearing problem, schedule an appointment for a hearing evaluation with a qualified professional. You’ll have a full examination of your hearing and will receive recommendations to help guide you in your next steps.

We hope this information has shed some light on this exciting new development.  As always, we are here to help!  Please contact us at (703) 748-3300 or reply to this email if you’d like to schedule an appointment to discuss your hearing health needs.  If you prefer to be unsubscribed from emails like these, please reply with “unsubscribe.”

Sincerely,
Dr. Crovato, Dr. Yunes, Dr. Trinka, and our patient care coordinator, Kate