Details surrounding over-the-counter hearing aids are still in the process of being finalized by the FDA, but there is a good amount of information that we can share with you at this time. Read on for our answers to FAQs about OTC hearing aids. And click here to read CHC's comments to the FDA on draft regulations for OTC hearing aids.
OTC Hearing Aids FAQs
1. What is an Over-the-Counter (OTC) hearing aid?
An OTC hearing aid, also known as direct to consumer, or DTC, is a new class of lower-priced, self-fit hearing aids that will be regulated by the FDA. OTC hearing aids are designed to be self-fit by consumers. OTC hearing aids are only for individuals who are age 18 or older and have a mild to moderate hearing loss.
2. What are prescription hearing aids?
Once the new OTC hearing aid category is officially established, more traditional hearing aids, those that are currently available and require the support of an audiologist or hearing aid dispenser, will be referred to as prescription hearing aids. 3. When will OTC hearing aids be available?
The OTC Hearing Aid Act was signed into law in 2017 and was expected to go into effect in 2020, but was delayed due to the pandemic. The FDA released initial guidelines in October of 2021. The FDA solicited and will incorporate feedback from industry, professionals and consumers and will issue finalized guidelines by the summer of 2022. It is expected that these new devices will be available for purchase in the fall of 2022.
4. Why is this new class of OTC hearing aids being created?
This initiative really began in 2015 when the President’s Council of Advisors on Science and Technology (PCAST) met and concluded that the use of hearing devices needed to be increased in individuals whose hearing had diminished in a mild to moderate way as a result of aging. They charged the FDA and other organizations to develop a pathway by which assistive devices would be more accessible. This new category of OTC hearing aids was created in response to this charge. OTC aids are anticipated to be more accessible for adults because they will likely cost less and be sold directly to the consumer online or at retail stores without the involvement of a hearing care professional.
5. Do I need to have a hearing test to purchase an OTC hearing aid?
A hearing test is not required to purchase an OTC hearing aid; however, CHC highly recommends a recent evaluation by an audiologist. The results help provide proper guidance on the best device and care and rule out any health issues.
6. Why are these products only for mild to moderate hearing loss?
The FDA has decided that people who have more than a moderate loss need amplification options that would not be safe to self-fit and must have the assistance of a hearing health care professional to ensure the hearing device is fit safely and accurately.
7. Will OTC hearing aids be less expensive than currently available hearing aids?
We anticipate that OTC hearing aids will be less expensive than most currently available hearing aids (referred to as prescription hearing aids), but as none are yet available, we do not have any estimates of cost.
8. How will OTC hearing aids be different from prescription hearing aids?
OTC hearing aids are expected to have fewer technological features and their performance might not match that of prescription aids. In addition, OTC hearing aids are expected to not include cost for any professional assistance in fitting, follow-up and warranties. Prescription hearing aids come in a range of price points and typically include professional fitting and warranties. 9. Are the OTC hearing aids just as good as my prescription hearing aids?
While we do not yet know what OTC hearing aids will be, we believe they will not have all of the features of prescription hearing aids. There will be different OTC hearing aids from different manufacturers and some will be better than others. 10. How do I decide which type of product to get, the OTC hearing aid or the prescription hearing aid?
If you are not sure which hearing device to get, the best route is to discuss this with your audiologist. At CHC we firmly believe that anyone considering an OTC hearing aid should first have a complete hearing test in order to determine if an OTC hearing aid might be good for you and rule out any hearing health issues. If you are considered to be a candidate for an OTC hearing aid based on your hearing loss, the ultimate decision will likely depend on what features you want the hearing aid to have, what types of listening situations you typically find yourself in, your ability to self-fit the device, and your budget. 11. Do I qualify for OTC Hearing Aids?
You qualify for an OTC hearing aid if you are 18 or older and have a “perceived” mild to moderate hearing loss. It is difficult to accurately determine if you have a mild or moderate hearing loss on your own. We highly recommend having a hearing test by an audiologist for the most accurate information about your hearing ability and hearing health. Hearing tests are covered by Medicare and Medicaid and most private insurances. Contact CHC to schedule your hearing test today.
CHC is Your Partner in Healthy Hearing
We hope you found this information helpful and look forward to sharing more news on OTC hearing aids as it develops. Should you have additional questions, please click here to submit them to us and we will get back to you.
The Center for Hearing and Communication is pleased to be your partner in healthy hearing. Click below to request an appointment for a hearing test or any other hearing-related service at our office in New York or Florida. Be well!
Details surrounding over-the-counter hearing aids are still in the process of being finalized by the FDA, but there is a good amount of information that we can share with you at this time. While regulations are being shaped, it reminds me a bit of how strategy in Agario evolves over time—just as the game starts simply, but layers of tactics emerge as you grow. Similarly, as the OTC hearing aid regulations become clearer, we can better understand how to navigate the options available. For now, you can explore our answers to FAQs about OTC hearing aids. And if you're curious, click here to read CHC's comments to the FDA on draft regulations for OTC hearing aids.
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