Over the Counter (OTC) Aids, You Say?!
It’s true! In August 2017 the US Senate passed the OTC Hearing Aid Legislation as part of the FDA (Food and Drug Administration) Reauthorization Act of 2017(FDARA).
Are they here now? No, OTC hearing aids are a new category of hearing aids that will be available for purchase in stores and online without a prescription. Currently, they don’t exist yet. This is because the FDA has not published regulations for this category of hearing aids yet. The expected date is August 2020 for regulations to be published. However, there will be a period for public comment, and then followed by the publication of finalized regulations.
What exactly are OTC hearing aids? Unfortunately, we don’t know yet, because the FDA has not finalized regulations yet. But for now, we know based on the FDARA:
1) OTC hearing aids will use “same fundamental scientific technology as […] hearing aids.”
2) OTC hearing aids will be “available over the counter, without the supervision, prescriptions, or other order, involvement, or intervention of a licensed person, to consumers through in-person transactions, by mail, or online.”
3) They will be for adults only (18+ years old).
4) They will provide adequate amplification for mild-to-moderate hearing losses.
5) The user will be able to control their OTC hearing aids and customize them as they see fit.
6) OTC hearing aids may include self-assessment tests.
7) OTC hearing aids may include wireless technologies.
So, what are the options today? Professionally fitted hearing aids are currently available through audiologists. Prices can vary in different areas of the country for hearing devices. Prices for OTC hearing aids are expected to range from $500-$1000 per device. For those that cannot afford professionally-fitted hearing aids, please consider looking into options for financial support. If you are not ready to pursue professionally fitted hearing aids, direct to consumer hearing aids and personal sound amplification products might be right for you. It should be noted that Direct-To-Consumer (DTC) hearing aids are hearing aids that are sold online or in stores, but that do not adhere to OTC hearing aid regulations. Personal Sound Amplification Products (PSAPs) are intended to “enhance” situational listening but should not be considered a solution for hearing loss.
Choice Audiology currently has professionally fitted hearing aids in the price range of OTC hearing aids, available now. We also offer DTC and PSAP options for patients who are not ready for hearing aids. We also offer financing options, lease options and rental options for hearing aids. We believe that price should NOT be a barrier for treatment.