The FDA’s New OTC Hearing Aid Regulations

What Does This Mean For Patients?

In 2017, the Food and Drug Administration (FDA) released its proposal to allow a new class of hearing aids to be sold over-the-counter (OTC) without a prescription and without a hearing evaluation. The intended purpose of this bill was to increase access and decrease the costs of obtaining hearing help. On August 16, 2022, the FDA released its final language, and we believe it is important to share this information with you. This will provide you, as the patient, with the facts so you can make educated decisions regarding your own hearing health.

The Facts:

• OTC hearing aids are a new class of devices. The FDA does not view them as equivalent to prescriptive hearing aids which require a licensed professional to dispense and provide ongoing care.
• OTC hearing aids are only meant for those individuals with ‘perceived’ mild to moderate hearing loss.
• No hearing evaluation is required.
• The purchaser must be 18 years of age or older.
• The purchaser should not have any ear/ auditory system medical contraindications (asymmetry, sudden hearing loss, tinnitus, intake of medication that causes hearing loss, history of chemotherapy of the head and/or neck, active ear drainage, ear pain or discomfort, dizziness).
• OTC hearing aids can be sold outside of a healthcare practice environment.

As professionals, we have been closely monitoring this legislation over the past 5+ years. We are in complete support of the concept that hearing care needs to be more accessible to all patients. That said, our core belief is that any person presenting with possible hearing loss should seek the collaborative help of professionals in the fields of Audiology and medicine. At a minimum, a comprehensive hearing evaluation should be required to help patients make informed decisions about OTC or prescriptive hearing aid options.

We expect OTC options to be available to the public in the upcoming months, along with a wave of news stories and advertisements. Our practice does not have immediate plans to offer OTC options as we are firm believers in a comprehensive, evidence-based, prescriptive approach to hearing aid fitting and care. We will continue to offer prescriptive hearing aid options and services, including professionally dispensed hearing aid options that are similar in cost to current OTC devices available on the market today.

You will certainly have questions as this story evolves. Please don’t hesitate to utilize us as your resource to help navigate the evolving hearing healthcare landscape.

Sincerely,

Craig A. Kasper, Au.D., FAAA, CCC-A

Distinguished Fellow, National Academies of Practice
Founder & Managing Director