MDHearing's Comments to the FDA Regarding the Proposed Over-the-Counter Hearing Aid Act Regulations

January 19, 2022 by Doug Breaker

MDHearing's Comments to the FDA Regarding the Proposed Over-the-Counter Hearing Aid Act Regulations

You may have heard about the new "Over-the-Counter Hearing Aid Act" law that will take effect in the fall of 2022. President Trump announced the law years ago, but Covid delayed the implementation of the law. The goal of the law is to provide more competition in the hearing aid market, and bring more affordable hearing aids to U.S. consumers. We applaud that goal, as it's been our mission for over a decade to bring high-quality, affordable hearing care to everyone.

The FDA published the first draft of the new law last fall, and asked for comments from interested parties. That comment period closed yesterday, and I'd like to share the comments we submitted to the FDA.

I've embedded a PDF of our full response below, and pasted a few key excerpts below.

The key feedback points we pass along to the FDA are:

Although we believe that consumers deserve affordable prices, we also strongly advocate that consumer safety and health remains paramount. In that spirit, we strongly agree with the feedback presented by Professor Frank R. Lin, M.D. Ph.D. of Johns Hopkins University. Specifically, we agree with Johns Hopkins’ recommendations of: 
  • A maximum permissible output of 120 dB SPL 
  • The FDA clarify that OTC hearing aid controls may only be applied to self-fitting hearing aids and hence subject to 510(k) review 

Why these points? Because these suggestions strike the right balance of opening the market to the greatest number of people in a safe way, while requiring strict testing and university studies to prove the effectiveness and safety of the hearing aids.

However, we would encourage the FDA to go even further to ensure that the health of consumers remain paramount. To achieve that goal, we submitted the following feedback:

In addition, we urge the FDA to consider further requirements to safeguard consumer health. Unfortunately, unscrupulous sellers fill the Direct to Consumer market today. The sellers do not offer any reasonable support, much less support from licensed hearing professionals. They do not test their products to ensure safety. Some outsource their support to untrained foreign call centers and put roadblock after roadblock in the way of customers returning their aids, racking up thousands of consumer complaints. Since our founding we have always employed licensed medical professionals and have tested every single batch of hearing aids for quality. 

Specifically, we offer the following input for your consideration to maximize consumer health: 
  • Specify a minimum return policy at the national level instead of leaving it to state regulations. If left to the states, this will create an opening for unscrupulous sellers to game the system.
  • Require every seller of OTC hearing aids staff customer support in the US with the ability for customers to meet with a licensed hearing professional via telemedicine technology
  • Require serial number tracking of every device shipped in case a device recall is needed
  • Require the frequency response and ANSI specifications of the aids to be included in the user manual
  • Require that every seller of OTC hearing aids demonstrate relevant ISO certification and comply with appropriate FDA quality systems
  • Define a national standard to sell Prescription hearing aids via telemedicine to adult patients over 18 who suffer from age-related hearing loss, as long as those patients do not have other medical issues that affect their hearing. We recommend calibrated, in-home air conduction and bone conduction tests, and video telemedicine appointments with licensed hearing professionals to achieve this goal.

We believe these recommendations will result in more affordable hearing care, while ensuring that consumer health remains top priority. Hearing aids are just one piece of the solution for better hearing health. Combining affordability, high-quality, and support and training from licensed hearing professionals will lead to the best consumer outcomes.

Doug Breaker
CEO
MDHearing