The session opened with Dr. Tom Tedeschi and a distinguished panel including representatives from Amplifon and the ADA. The main message emphasized the urgent need for states to update their audiology and hearing aid dispensing laws in light of the FDA’s 2022 rule, which reclassified many hearing aids from restricted to prescription devices and simultaneously introduced over-the-counter (OTC) categories.
The FDA’s action, while aiming to increase access, created regulatory confusion at the state level. States must now explicitly authorize audiologists and hearing aid specialists to “prescribe” or “order” hearing aids—language that many existing laws lack. This omission could inadvertently exclude professionals from legally fitting and dispensing hearing aids under the new federal framework.
Panelists stressed that the terms “prescribe” or “order” must be included in state laws or administrative guidance to ensure continuity of care. Two pathways were discussed: (1) legislative amendments using the proper terminology, and (2) interim administrative guidance or FAQs issued by state boards or departments of health.
The presentation offered case studies from Maryland and Kentucky, which successfully updated their laws by ensuring collaboration between audiologists and hearing instrument specialists. Other states like New York and Florida were highlighted for their challenges, particularly due to fragmented authority between state agencies and reluctance to adopt the precise federal terminology.
The legal concepts of casus omissus (unintentional omission implies exclusion) and expressio unius est exclusio alterius (listing one implies exclusion of others) were introduced to explain why explicit language is necessary. Without it, professionals may be denied prescribing authority, leading to barriers for patients.
The webinar concluded with practical advice for stakeholders: review your state laws and engage with national organizations like ADA for model language and support. Collaboration and proactive communication between stakeholders were emphasized as key to preventing unintended limitations on professional practice and ensuring patient access to care.
In essence, this webinar was a call to action for audiology professionals to advocate for policy alignment at the state level to preserve and expand patient access to hearing healthcare.