OTC Hearing Aids feat. Michael Scholl | Chief Compliance Officer at Starkey

The Hearing Matters Podcast discusses hearing technology (more commonly known as hearing aids), best practices, and a growing national epidemic - Hearing Loss. The show is hosted by father and son - Blaise Delfino, M.S., HIS, and Dr. Gregory Delfino, CCC-A. Blaise Delfino and Dr. Gregory Delfino treat patients with hearing loss at Audiology Services, located in Bethlehem and Nazareth, PA.

In this episode, Blaise discusses over-the-counter hearing aids and Medicare benefits for hearing instruments with Michael Scholl, chief compliance officer and vice president of corporate relations at Starkey. 

The Beginning 

Talk of OTC hearing aids started back in 2016-2017 when President Trump signed the FDA Reauthorization Act. The FDA was to create an OTC category by August of 2020. In October,2021 the FDA finally released the draft of OTC hearing aid regulations that is available for public comment over the next 90 days. The public comment period concludes on January 18, of 2022. The FDA will take all of those public comments into account, and then promulgate a final rule. By summer of 2022, we will see a final OTC regulation, and it will go into effect 60 days after they finalize that rule.

More Harm than Good?

There are a few safety concerns about the OTC aids. The auditory industry, consumer groups and audiologists are asking for the aids to have a maximum output of 110 dB and a maximum gain of 25 dB. In the proposed regulation, the max output could get to 120 dB. The difference between 110 and 120 is significant and could cause damage to someone’s hearing. Also, consumers need to clearly understand who and where there is enforcement over the hearing aids. Only those over 18 should be able to purchase these hearing aids.

Medicare Coverage 

As Congress looks to pass the Build Back Better law, there are two things the hearing healthcare industry has to focus on. The first is to get Congress to get the bill in the best possible shape before it goes to a vote. Once it is passed, it goes to the Centers for Medicare and Medicaid will write part of the language of the law. There are a few items that are really important. First, a hearing aid is a prosthetic, not durable medical equipment. A hearing aid is not a cane, it's not a walker, it's not a one-time product. it's a medical device that is continually fine-tuned.  Number two is that the hearing aids are exempt from competitive bidding. And third is that an audiologist and a hearing instrument specialist can provide the help to Medicare recipient.

Listen Carefully

This fall, Starkey launched Listen Carefully. People can find out what's happening with Medicare coverage and OTC hearing instruments in Washington. The public comment period is happening now. People can write comments, and there are draft comments people can use and add their own thoughts. Starkey works very hard to educate legislators at the state and federal level. Michael encourages all audiology practices to get involved at the local level as well. Hearing healthcare is a non-partisan issue. Everyone everywhere wants people to understand that untreated hearing loss dramatically affects overall health.

A New Era

Michael says he believes one day soon that the hearing healthcare industry will no longer be on the defensive. He believes there will be more access to hearing healthcare and people

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