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OVER-THE-COUNTER HEARING AID REGULATIONS MUST PROTECT PATIENTS ABOVE ALL ELSE

On October 19, the U.S. Food and Drug Administration (FDA) proposed rules for over-the-counter (OTC) hearing aids. As you likely know, this started a 90-day public comment period to ensure all voices are heard and lawmakers get these rules right. This public comment period is now closed.

However, your voice can still make a difference by encouraging your state attorney general (AG) to keep pushing for strong consumer protections in the OTC hearing aid rule! 

These rules are designed with the purpose to provide greater access to hearing assistance for those with perceived mild-to-moderate hearing loss. However, without proper guardrails in place to protect patient’s long-term hearing health, these products could result in more harm than help.

As currently written, the proposed rules would repeal virtually all exemptions from preemption for state and local rules. This means state regulators would not be able to enforce stronger levels of protection for their constituents and consumers, jeopardizing the state’s overall public health. In response to this, a bi-partisan group of over 40 state AGs sent a letter to the FDA urging them to amend this problematic provision in the proposed OTC hearing aid rules. 

Please join us in thanking these AGs for their commitment to consumer safety and requesting that they continue their efforts to ensure those suffering from perceived mild-to-moderate hearing loss have access to safe, effective hearing products.

Remember: Federal regulations should encourage stronger protections, not weaken them. 

It is our hope that the FDA will Listen Carefully and put safety first.

 

OVER-THE-COUNTER HEARING AID REGULATIONS MUST PROTECT PATIENTS ABOVE ALL ELSE

On October 19, the U.S. Food and Drug Administration (FDA) proposed rules for over-the-counter (OTC) hearing aids. As you likely know, this started a 90-day public comment period to ensure all voices are heard and lawmakers get these rules right. This public comment period is now closed.

However, your voice can still make a difference by encouraging your state attorney general (AG) to keep pushing for strong consumer protections in the OTC hearing aid rule! 

These rules are designed with the purpose to provide greater access to hearing assistance for those with perceived mild-to-moderate hearing loss. However, without proper guardrails in place to protect patient’s long-term hearing health, these products could result in more harm than help.

As currently written, the proposed rules would repeal virtually all exemptions from preemption for state and local rules. This means state regulators would not be able to enforce stronger levels of protection for their constituents and consumers, jeopardizing the state’s overall public health. In response to this, a bi-partisan group of over 40 state AGs sent a letter to the FDA urging them to amend this problematic provision in the proposed OTC hearing aid rules. 

Please join us in thanking these AGs for their commitment to consumer safety and requesting that they continue their efforts to ensure those suffering from perceived mild-to-moderate hearing loss have access to safe, effective hearing products.

Remember: Federal regulations should encourage stronger protections, not weaken them. 

It is our hope that the FDA will Listen Carefully and put safety first.