Clock is Ticking on FDA OTC Submission Deadline

December 20, 2021


Michael Scholl, Starkey Chief Compliance Officer and Executive Vice President of Corporate Relations, outlines his point of view on the upcoming OTC submission deadline.


Eden Prairie, Minnesota (December 20, 2021) - Over-the-counter hearing aids (OTC) have been a topic of conversation and concern across the hearing industry for several years. The FDA is now months away from finalizing the OTC hearing aid regulation. That’s why it has never been more important for hearing healthcare professionals to act – and act quickly – to have their voices heard by the decisionmakers in Washington, D.C. The deadline for public comments is January 18, 2022. Here’s what’s at stake:


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 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.

​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.


We encourage 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. If you’re not sure how to do that or where to start, we’ve created an advocacy platform, called Listen Carefully, to provide more information. The website is www.listencarefully.org. You can also listen to the most recent episode of the Starkey Sound Bites podcast, during which Dr. Dave Fabry and I discuss this subject in depth.


On behalf of everyone at Starkey, I want to thank our partners in better hearing for continuing to put in the hard work to ensure patients have every opportunity to hear better, so they can live better.


This release appeared on Audiology Online news page.