Over-The-Counter Hearing Aids
What are they, and when will they be available?
11 September 2018
Over-The-Counter (OTC) hearing aids are a new category of hearing aids that will soon be available for purchase in stores and online without a prescription.
When will over-the-counter hearing aids be available?
Technically, Over-The-Counter hearing aids don’t exist yet. The FDA is expected to publish proposed regulations for the new category of hearing aids by August 18, 2020. Following the publication of the proposed regulations there will be a public comment period, and this will be followed by the publication of finalized regulations. See timeline.
What exactly are over-the-counter-hearing aids?
We’ll know a lot more once the FDA publishes regulations, but for now, here’s what we know based on the FDA Reauthorization Act of 2017 (FDARA):
- OTC hearing aids will use “same fundamental scientific technology as […] hearing aids”
- OTC hearing aids will be “available over-the-counter, without the supervision, prescription, or other order, involvement, or intervention of a licensed person, to consumers through in-person transactions, by mail, or online.”
- They will be for adults only (18+ years old)
- They will provide adequate amplification for mild-to-moderate hearing loss
- The user will be able to control their OTC hearing aids and customize them as they see fit
- OTC hearing aids may include self-assessment tests
- OTC hearing aids may include wireless technologies
What are your options today?
Professionally-fitted hearing aids are currently available for purchase through state-licensed audiologists and hearing instrument specialists. The average price for a professionally-fitted hearing aid, including a hearing aid fitting and and follow up care, is $2372, according to a recent Hearing Tracker survey.
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, but still need help hearing, take a look at our product directories for direct-to-consumer hearing aids and personal sound amplification products.
Update for October 2018: Bose has been authorized to market the Bose Hearing Aid as a direct-to-consumer self-fitting hearing aid.
OTC Hearing Aid Timeline
FDA Draft Regulation Expected
Draft regulation from the FDA is expected on or before this day. Once published, the FDA will accept public comments, and this will be followed by the publication of the finalized regulations.
President Trump Signs OTC Hearing Aid Legislation into Law
The Over the Counter Hearing Aid Act was signed into law by President Trump, as a part of The FDA Reauthorization Act of 2017 (FDARA)
US Senate Passes OTC Hearing Aid Legislation
The Over-The-Counter Hearing Aid Act of 2017 passes through the senate as a part of The FDA Reauthorization Act of 2017 (FDARA).
OTC Hearing Aid Legislation Passes Through House
The Over-The-Counter Hearing Aid Act of 2017 passes through the house as a part of The FDA Reauthorization Act of 2017 (FDARA). The OTC Hearing Aid Act was previously merged into the Medical Device User Fee and Modernization Act (MDUFA), which itself was passed as part of the FDARA.
OTC Hearing Aid Act of 2017 Introduced
The Over-The-Counter Hearing Aid Act of 2017 was introduced into the 115th Congress by US Senators Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa). The Act was originally introduced on 06 Nov 2016, but was re-introduced in the new congressional session.
Note: 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 (since regulations have yet to be published). Personal Sound Amplification Products (PSAPs) are intended to “enhance” situational listening, but should not be considered a solution for hearing loss.