Over-the-counter (OTC) hearing aid regulations — What you need to know

On the latest episode of Starkey Sound Bites, Starkey Chief Compliance Officer and Executive Vice President of Corporate Relations, Michael Scholl, sat down with Dr. Dave Fabry to talk about changes to hearing healthcare regulations, prescription hearing aids vs over-the-counter hearing aids, and how hearing care providers and patients can participate in conversations currently happening in Washington, D.C.

Over-the-counter hearing aids (OTC) have been a topic of conversation across the hearing industry for several years. The FDA is now months away from finalizing the OTC hearing aid regulations. The deadline for public comments is January 18, 2022. Here’s an overview:

In October, the FDA released draft regulation for OTC hearing aids, designed to provide greater access to hearing assistance for those with perceived mild-to-moderate hearing loss. However, without proper guardrails in place to protect patients’ long-term hearing health, these products could potentially result in more harm than help.

As currently written, the proposed rule includes a few areas that need to be addressed, 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 perceived 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.

According to Scholl, “A hearing aid is not a consumer electronics device; it is a medical device and should be regulated as such. Federal regulations should encourage stronger protections, not weaken them. As the largest U.S. hearing aid manufacturer, we support greater access and affordability for hearing aids, but not if it means compromising patient safety and satisfaction. Because hearing loss is unique to each individual patient, we at Starkey believe it is critically important that licensed, trained hearing health professionals continue to play a key role in someone’s hearing loss journey.”

Scholl encourages hearing health professionals to submit their feedback to strengthen these proposed regulations and ensure OTC hearing aids are used as intended — for those only with perceived mild-to-moderate hearing loss. Starkey has created an advocacy platform, called Listen Carefully, to provide more information. Check out listencarefully.org and listen to Dave and Michael’s conversation here.


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By Starkey Hearing