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OTC HEARING AID REGULATIONS MUST PROTECT PATIENTS ABOVE ALL!

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

These devices are a new category of hearing aids that consumers will be able to buy directly, without visiting a hearing health professional. They are intended to help adults who believe they have mild-to-moderate hearing loss, at budget friendly prices. However, lower prices often result in lower quality of care. Without proper guardrails in place to protect patient’s long-term hearing health, these products could result in more harm than help.

The FDA’s current proposal trusts OTC hearing aid users to self-diagnose “mild-to-moderate” hearing loss based on labeling, but there is no indication that the FDA has validated the labeling to verify individuals can self-diagnose accurately. Even more concerning, the FDA has allowed amplification in OTC hearing aids of up to 120 decibels (equivalent to the sound of a chain saw). This gives devices enough power to assist even those with severe to profound hearing loss, potentially incentivizing individuals who need expert attention to avoid seeking professional help.

Lastly, the currently proposed rules repeal the FDA’s recognition of state and local enhanced consumer protections for both OTC and non-OTC hearing aids. Federal regulations should encourage stronger protections, not weaken them.

A hearing aid is not a consumer electronics device; they are medical devices and should be regulated as such.

To properly protect patients and provide adequate help for mild-to-moderate hearing loss, FDA’s OTC hearing aid regulations should:

  • Impose a gain limit of 25 decibel and an overall output limit of 110 decibel
  • Validate the proposed labeling statements to ensure users can accurately self-diagnose their level of hearing
  • Preserve state and local public health and consumer protections for both non-OTC and OTC hearing aids
  • Require warranties and returns as conditions of sale for all hearing aids

We encourage Americans to submit comments through this form to strengthen these proposed regulations. It is our hope that the FDA will Listen Carefully and put patient safety first.

OTC HEARING AID REGULATIONS MUST PROTECT PATIENTS ABOVE ALL!

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

These devices are a new category of hearing aids that consumers will be able to buy directly, without visiting a hearing health professional. They are intended to help adults who believe they have mild-to-moderate hearing loss, at budget friendly prices. However, lower prices often result in lower quality of care. Without proper guardrails in place to protect patient’s long-term hearing health, these products could result in more harm than help.

The FDA’s current proposal trusts OTC hearing aid users to self-diagnose “mild-to-moderate” hearing loss based on labeling, but there is no indication that the FDA has validated the labeling to verify individuals can self-diagnose accurately. Even more concerning, the FDA has allowed amplification in OTC hearing aids of up to 120 decibels (equivalent to the sound of a chain saw). This gives devices enough power to assist even those with severe to profound hearing loss, potentially incentivizing individuals who need expert attention to avoid seeking professional help.

Lastly, the currently proposed rules repeal the FDA’s recognition of state and local enhanced consumer protections for both OTC and non-OTC hearing aids. Federal regulations should encourage stronger protections, not weaken them.

A hearing aid is not a consumer electronics device; they are medical devices and should be regulated as such.

To properly protect patients and provide adequate help for mild-to-moderate hearing loss, FDA’s OTC hearing aid regulations should:

  • Impose a gain limit of 25 decibel and an overall output limit of 110 decibel
  • Validate the proposed labeling statements to ensure users can accurately self-diagnose their level of hearing
  • Preserve state and local public health and consumer protections for both non-OTC and OTC hearing aids
  • Require warranties and returns as conditions of sale for all hearing aids

We encourage Americans to submit comments through this form to strengthen these proposed regulations. It is our hope that the FDA will Listen Carefully and put patient safety first.