Academy of Doctors of Audiology
April 04, 2023
A Prescription for Change – How to Conform State Laws to FDA Prescription Hearing Aid Regulations and Protect Consumer Access to Care
Posted in: All News

State audiology advocacy efforts have intensified, in response to new Over-the-Counter (OTC) and prescription hearing aid regulations, implemented by the U.S. Food and Drug Administration (FDA) in 2022, with the most critical initiatives focused on ensuring that practice statutes for audiologists and hearing aid specialists are amended to conform with FDA regulations for prescription hearing aids, so that consumers continue to have ready access to the care that they need.

Register for this important state advocacy briefing webinar, which will summarize the FDA regulations necessitating amendments to state audiology and hearing aid dispensing laws across the nation, provide a status update on policy initiatives in each state, and offer attendees actionable information, resources, and collaborative models that they can use to address any policy deficiencies in their states, through legislative, regulatory, and/or administrative action.

When: Tuesday, April 11th
Time: 1:00 p.m. Eastern Time
Learning Outcomes:

  1. Attendees will be able to describe the FDA regulations for OTC and prescription hearing aids and why those regulations have necessitated updates to state laws.
  2. Attendees will be able to assess whether the laws in their state have been updated to include necessary language to conform with the FDA regulations and support consumer access to care.
  3. Attendees will be able to list three actions that they can take to address policy deficiencies related to OTC and/or prescription hearing aid laws in their state.



Meet the Presenters

Alicia D.D. Spoor, Au.D. is President of Designer Audiology, LLC in Highland, Maryland. She earned her Doctor of Audiology degree from Gallaudet University and completed her fourth-year externship at the Mayo Clinic Arizona. Dr. Spoor is a Past President of the Academy of Doctors of Audiology (ADA) and Maryland Academy of Audiology (MAA); she is the current ADA Advocacy Chair and MAA Legislative Chair.

Michael Belaen is the Senior Vice President of Regulatory Affairs and Deputy General Counsel for Amplifon Americas where his is responsible for planning, developing, and achieving Amplifon's strategic government relations, regulatory affairs, and legal priorities across North America. Michael is an attorney with senior-level experience across numerous industry, legal, and policy areas. Michael earned his bachelor’s degree in political science from the University of Minnesota and his juris doctorate from Mitchell Hamline School of Law.

Shruti Kulkarni is the Senior Director of Regulatory Affairs and Associate General Counsel at Amplifon. Prior to joining Amplifon, Ms. Kulkarni was a partner at a law firm, where she provided counsel to pharmaceutical, biotechnology, and medical device companies on federal and state legal, legislative, regulatory, and enforcement matters. Ms. Kulkarni obtained her Juris Doctor degree from George Mason University School of Law.

Tom Tedeschi, Au.D. is the Chief Audiology Officer for Amplifon Americas. Primary responsibilities center around Governmental Affairs and Regulatory activities. He holds a doctorate degree in Audiology. Dr. Tedeschi has worked in a number of sectors throughout his 45-year career, hospital based, private practice, teaching, and industry related positions. He has co-authored chapters on Ethics in Audiology in two books, and recently co-authored a chapter on Practice Management.

Stephanie Czuhajewski, MPH, CAE mission to promote evidence-based clinical and business practices in the delivery of audiology services and to advance the profession of audiology. She holds a master’s degree in public health from the University of New England.

ADA is grateful for Amplifon’s support of this important webinar and its collaboration on state advocacy efforts to align state laws with the FDA regulations.