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Over the Counter Hearing Aids

In August of 2017, Congress passed the FDA Reauthorization Act, which included the Over the Counter Hearing Aid Act.  President Trump signed it into law on August 18, 2017.

You may read the FDA Reauthorizaton act here (OTC Hearing Aids on pages 61-63)

In short, the government has until August 2020 to develop a common set of regulations that will govern the Over the Counter Hearing Aid industry specifically for those with mild to moderate hearing loss.  This one set of federal regulations will preempt the outdated, individual state laws that have hindered access to hearing aids by limiting availability and keeping prices too high for many Americans to afford.

Presently, it is permissible under federal regulation to sell Class 1 Air Conduction Hearing Aids direct to consumers without a doctor's prescription if 1) the supplier and the supply chain have the appropriate FDA Registrations and Medical Device Licenses, and 2) the product has cleared an FDA document review upon import (if imported).  For years, Hearing Assist has been stringently meeting these standards.  However, there remain some older, state laws that require hearing aids be purchased from state licensed distributors and audiologists.  

 

Hearing Assist welcomes the fact that the OTC Hearing Aid Act will finally provide clarity and preempt the various state laws so we can have a single open and safe marketplace and a common set of marketing and performance guidelines. We will adhere to all OTC guidelines as soon as they are published.

At Hearing Assist, our overall goal has always been to bring high quality, low-cost hearing healthcare to American consumers with mild to moderate hearing loss.  We could absolutely charge more for our products, but we choose not to. We feel that our seniors are already taxed enough financially, and insurance doesn’t typically cover these life-altering devices, which we find appalling; we want to be the solution, not part of the problem. With our large US-based customer service operation and our experience in the wholesale and retail business, as well as relationships at mass retailers, it is you, our valued customer, who will benefit the most from the opening of this market.

We welcome your comments and inquiries.  Please email us at fda@hearingassist.com