Continuing Education Presentation
Over-The-Counter Hearing Aid Sales
What's Legal, What's Not, What's Next?
THAA Legal Counsel
Giles Aseron, PLLC
Saturday Afternoon - June 24
Probably the most misunderstood issue in the hearing aid industry is the difference between "selling" a hearing aid and "fitting and dispensing" one, according to current federal and state laws governing the sale of hearing aids. Throw in the FDA's announcement last December that it will no longer enforce the medical evaluation requirement that has been in effect for over 40 years, and the question of what's legal and what's not legal when it comes to the sale of hearing aids becomes unclear at best. So, what is legal and what is not? Which sales of hearing aids require a license to fit and dispense, and which ones don't?
This presentation will discuss the legality (and illegality) of over the counter hearing aid sales according to current federal and state laws and regulations governing the sale of hearing instruments in Texas. The presentation will cover the Medical Device Amendments of 1976 and the subsequent federal regulations issued by the Food and Drug Administration that have governed the sale of hearing aids in all states for over 40 years.
What's Next? Last fall, Senators Elizabeth Warren and Chuck Grassley introduced the Over-the-Counter Hearing Aid Act of 2016, which would allow hearing aids intended to compensate for mild-to-moderate hearing loss to be sold over the counter. This federal legislation also asks the FDA to issue new regulations containing safety and labeling requirements for this new category of OTC hearing aid and update its draft guidance on Personal Sound Amplification Products (PSAPs). This presentation will look at the contents of this bill and how it could affect hearing aid sales and traditional hearing aid delivery models for years to come.
- Attendees will understand the content and application of the Medical Device Amendments of 1976, their purpose, and their application in modern day hearing aid delivery models.
- Attendees will understand the application of current FDA regulations governing the sale of hearing aids in CFR 801.420 and CFR 801.421, and learn the real reason the FDA announced it will no longer enforce the medical evaluation requirement contained in these regulations.
- Attendees will emerge with a complete understanding of the difference between “selling a hearing aid” vs “fitting and dispensing hearing aids” as defined by federal law and regulations and how Chapter 402 of the Texas Occupations Code (dispenser licensing act) works in conjunction with these federal regulations.
- Attendees will understand the content of the proposed Over-the-Counter Hearing Aid Act of 2016 and how it could affect dispenser licensing models if passed.
Adam C. Aseron is a founding member of Giles Aseron PLLC. His principal area of practice is healthcare law, with an emphasis on regulatory and transactional matters. Adam represents hospitals, physicians, state associations, and other healthcare entities, as well as healthcare industry investors, in connection with business transactions and ventures, federal and state regulatory matters, and day-to-day operations and compliance issues. Adam regularly advises clients on fraud and abuse issues under the anti-kickback and self-referral laws, provider agreements, third-party payor reimbursement, HIPAA and other information privacy and security laws, legislative and rulemaking initiatives, healthcare reform, EMTALA, entity formation, corporate practice of medicine, licensure, and operational matters.