FDA OTC Hearing Aid Rule Impact on States

UPDATE: FDA Issues Clarification Letter on the Impact of OTC Hearing Aid Rule on States (10/17/2022)

The Food and Drug Administration’s (FDA) final rule classifying over-the-counter (OTC) hearing aids has resulted in a paradigmatic shift affecting how all hearing aids are sold and marketed nationwide. ASHA has been active in helping our members and state affiliates understand the implications of two critical components of the FDA rule: the designation of non-OTC hearing aids as “prescription devices” and the repeal of federal medical evaluation requirements.

Designation of Non-OTC Hearing Aids as Prescription Devices
In creating the new category of OTC devices, the FDA has redesignated traditional (non-OTC) hearing aids as “prescription devices.” This has created confusion that a licensed audiologist may not be allowed to fit and dispense a prescription hearing aid if their state law does not expressly denote them as a prescriber. This confusion could severely affect access to prescription hearing devices by limiting the number of audiologists who can order their use, even though they have done so for decades.

ASHA’s Advocacy Efforts
ASHA has responded to this issue by urging the FDA to clarify that reclassifying non-OTC hearing aids as “prescription devices” is not intended to prevent licensed practitioners—who are authorized to order the use of these devices—from continuing to do so. In addition, we are working with our state affiliates to push local policymakers to alter their regulations to meet the FDA definition.

Repeal of Federal Medical Evaluation Requirements
Under the final rule, the FDA repealed its existing medical evaluation requirements, giving authority back to the states to implement medical evaluations as part of hearing aid dispensing as they see fit (for non-OTC hearing aids). With FDA rules no longer overriding state medical evaluation laws, ASHA is concerned that some states may maintain medical evaluation requirements that unnecessarily restrict the ability of audiologists to fit and dispense hearing aids.

ASHA’s Advocacy Efforts
ASHA strongly urged the FDA to confirm that the OTC hearing aid rule does not require states to implement medical evaluation requirements for prescription hearing aids for adults. In addition, ASHA will be engaging with state policymakers to repeal any laws that unduly restrict audiologists from fitting and dispensing hearing aids.

Background
Throughout the rulemaking process, ASHA has been a leader in advocating to ensure the FDA adopts appropriate consumer protections and maintains the vital role of audiologists in fitting and dispensing hearing aids.

Prior to the release of the OTC hearing aid proposed rule, ASHA was advocating for state policymakers to prepare for its release and pushed back against state efforts to eliminate consumer protections and diminish the role of audiologists in addressing hearing loss.

What’s Next?
In the coming months, ASHA will continue to update members on our collaborative advocacy efforts addressing OTC hearing aids. We also welcome your feedback and perspectives about these policy changes. If you have questions about ASHA’s work in this arena or how it impacts your state, contact us at states@asha.org.

See also:
• Comment Letter to FDA on Request for Guidance on State Regulation of Medical Waivers and Licensed Practitioners Related to the Use of Prescription Hearing Aid, September 16, 2022 [PDF]
• Over-the-Counter Hearing Aid Toolkit