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OTC HEARING AID REGULATIONS MUST PROTECT PATIENTS!

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. 

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 rules have some problematic sections, including:

  • The onus is on 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.
  • There is nothing to prevent manufacturers from combining OTC hearing aids with other wearable consumer technologies, potentially expanding use well beyond adults with mild-to-moderate hearing loss.
  • The FDA has allowed amplification in OTC hearing aids of up to 120 decibels (equivalent to the sound of a chain saw), giving devices enough power to assist even those with severe to profound hearing loss and potentially incentivizing individuals who need expert attention to avoid seeking professional help.
  • The proposed rules would repeal virtually all the exemptions from preemption for state and local rules, threatening public health and consumer protections.
  • A lack of a consistent, federally mandated standard of protection.

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

Federal regulations should encourage stronger protections, not weaken them. We encourage hearing health professionals to submit comments through this form to strengthen these proposed regulations and ensure OTC hearing aids are used as intended, for those only with mild-to-moderate hearing loss.

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

 

OTC HEARING AID REGULATIONS MUST PROTECT PATIENTS!

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. 

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 rules have some problematic sections, including:

  • The onus is on 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.
  • There is nothing to prevent manufacturers from combining OTC hearing aids with other wearable consumer technologies, potentially expanding use well beyond adults with mild-to-moderate hearing loss.
  • The FDA has allowed amplification in OTC hearing aids of up to 120 decibels (equivalent to the sound of a chain saw), giving devices enough power to assist even those with severe to profound hearing loss and potentially incentivizing individuals who need expert attention to avoid seeking professional help.
  • The proposed rules would repeal virtually all the exemptions from preemption for state and local rules, threatening public health and consumer protections.
  • A lack of a consistent, federally mandated standard of protection.

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

Federal regulations should encourage stronger protections, not weaken them. We encourage hearing health professionals to submit comments through this form to strengthen these proposed regulations and ensure OTC hearing aids are used as intended, for those only with mild-to-moderate hearing loss.

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