Did you know hearing loss is one of the most common chronic conditions in the US and increasing accessibility and affordability are the primary reasons for the push to allow the sale of OTC hearing aids?
Did you know in 2017 Congress passed a law that mandates FDA to create a new category of hearing aids designated for perceived mild-to-moderate hearing losses?
These devices would be available over-the-counter, without the supervision of a hearing health care professional. This law is intended to increase consumer choice and access to devices that treat mild to moderate hearing impairment.
FDA’s Congressional mandate is to draft regulations that ensure these medical devices will be safe and effective, protecting consumers from health risks associated with over amplification or ineffective products.
There will be many new choices on the market. Consumers need information to make an informed decision and ensure a safe and effective experience.
The leading scientific voices on hearing care have concluded in a recent consensus paper that the best way to protect consumers is to control the amplification of these over-the-counter consumer devices by regulating the decibel gain (volume) and the decibel output (maximum loudness).
This is where we need your help. To fulfill its Congressional mandate to protect consumer health FDA should regulate these OTC hearing aids based on a scientifically based medical standard, not a consumer electronics standard.
And, that standard should be easily accessible, and should make comparing devices easy for consumers.
Your Member of Congress needs to ensure this regulation is done right. Ask them to hold FDA accountable by ensuring that proper safety specifications are put into place with the development of the technical and device specifications.
GET INFORMED AND SEE WHAT MEDICAL AND INDUSTRY EXPERTS SAY
Qualified hearing care professionals have agreed on recommendations for sensible OTC hearing device safety and effectiveness. Download their consensus paper that lays out 5 evidence-based and science-supported priorities for FDA consideration.