The FDA Final Rule Establishing OTC Hearing Aids

The FDA Final Rule Establishing OTC Hearing Aids

Kim Cavitt, Au.D.

From the 1960s, until now, there has not been, officially, over the counter (OTC) hearing aids. There have been personal sound amplification products (PSAP), or Food and Drug Administration (FDA) registered legacy, air-conduction and wireless class hearing aids dispensed in person, through a licensed provider, via a direct to consumer (DTC) channel, with engagement from a licensed provider, or over the counter (mail order, online/internet, or retail), without provider engagement.

The FDA requirements were limited to air-conduction hearing aids:

  1. manufacturing requirements for Class I or Class II medical devices,
  2. labeling requirements,
  3. medical clearance for anyone under the age of 18,
  4. medical clearance or medical waiver for anyone 18 years of age or older, and
  5. dissemination of a user brochure.

The FDA did not require a hearing test, a prescription, return for credit privileges, or a trial period. The States created these additional regulations decades ago. There has been little-to-no enforcement, for decades, of FDA requirements when the devices are delivered OTC or DTC, which makes this all the more confusing. This is one reason why implementation of the Final FDA OTC Rule will be valuable to consumers and providers.

Beginning October 17, 2022, there will be an FDA class of OTC hearing aids, with specific manufacturing and labeling requirements and an FDA class of prescription hearing aids (which include legacy, air-conduction, bone-conduction, wireless and self-fitting devices), with specific manufacturing and labeling requirements.

On October 18 and beyond, no State can legally put restrictions on the retail sale of the OTC category, outside of what has been required by the FDA. For example, there are no requirements for evaluation, return for credit or trial periods with the OTC class. Now, States CAN create regulations for licensed providers in the fitting of ANY class of hearing aid where the FDA provides no regulation. Per the FDA Final Rule: “For example, a State may require a license for a hearing aid fitter, because “fitting” is not listed among the activities in section 709(b)(4) of FDARA, and we do not interpret any of the listed activities to include fitting. A person could not be a fitter in that State, even for OTC hearing aids, without a license. However, the State could not require a hearing aid fitting prior to a user purchasing an OTC hearing aid because that would restrict or interfere with commercial activity involving OTC hearing aids”.

As it pertains to prescription class devices, the FDA defines this category as “a device that is:

    1. either in the possession of a person, or his agents or employees, regularly and lawfully engaged in the manufacture, transportation, storage, or wholesale or retail distribution of such device or in the possession of a practitioner, such as physicians, dentists, and veterinarians, licensed by law to use or order the use of such device and
    2. is to be sold only to or on the prescription or other order of such practitioner for use in the course of his professional practice”.

Per the FDA, the prescription class will “be sold only to or on the prescription or other order of a practitioner licensed by law to use or order the use of (prescribe) the devices”. States may continue to regulate the hearing aids, that now fall within the prescription class, as they have for many years. The States will again determine the evaluation, prescription, return for credit, trial period and dispensing provisions of this class of device. I suspect consumers do not want it to be harder to get prescription hearing aids than it is today.

Audiologists in each state will need to define what a “prescription for a hearing aid” entails and who can provide such prescription. Our best correlate of this would be the Federal Trade Commission’s (FTC) Eyeglass Rule: Some considerations are the type and level of evaluation or testing required, the assistive technology required, the style and features required of recommended technology and how this prescription is supplied to the user. For example, a state might consider an evaluation that consists of pure-tone air conduction testing, bone-conduction testing or the Consumer Ear Disease Risk Assessment (CEDRA;, speech/digits in noise testing. The recommendation might include binaural receiver in canal hearing aids, with a minimum of 10 channels, multiple program options that can be accessed from their cellular phone, noise suppression/compression, directional microphones, a telecoil, Bluetooth connectivity and rechargeability.

It is important that audiologists ENGAGE at the State level, through State association membership and volunteer activities, to make these decisions for prescriptions and provider delivered care in their state. Every State hearing aid dispensing law will need to be addressed to account for these FDA regulatory changes. ■

Dr. Kim Cavitt was a clinical audiologist and preceptor at The Ohio State University and Northwestern University for the first ten years of her career. Since 2001, Dr. Cavitt has operated her own Audiology consulting firm, Audiology Resources, Inc. She currently serves on the State of Illinois Speech Pathology and Audiology Licensure Board. She also serves on committees through AAA and ASHA and is an Adjunct Lecturer at Northwestern University.