The FDA recently finalized regulations that apply to the new over the counter (OTC) hearing aid category. These devices become available for purchase on October 17, 2022.

The purpose of the OTC category was to increase access and lower the cost of getting hearing help. Because studies show a link between untreated hearing loss and falls, loneliness, and cognitive decline etc., timely treatment is important.

OTC hearing aids will be sold in audiology clinics as well as other retailers, without a prescription and without a hearing evaluation. These devices are intended to be self-fitted by the consumer and they have no mandated return policy. Pricing will be determined by the manufacturers, but estimates are that they will cost between $300-$600 per device.

OTC devices are intended for those 18 years or older with perceived mild to moderate hearing loss. They are not meant for those with unilateral, asymmetrical, or sudden hearing losses. Those with tinnitus, drainage, ear pain, dizziness, or history of chemotherapy and/or radiation to the head/neck should be medically evaluated prior to any hearing aid purchase.

Prescriptive devices will continue to be professionally fit by an audiologist.

My Professional Advice:

• OTC hearing aids may be an appropriate first step for some patients. While a hearing evaluation is not mandatory for purchase, I would recommend a comprehensive hearing evaluation to rule out any medical concerns and make sure you can receive benefit from the OTC devices.

• If OTC devices aren’t providing benefit, please don’t give up on hearing loss treatment altogether. Ask your audiologist to help develop a customized treatment plan for your specific needs.

• Lean on the expertise of an audiologist as your trusted hearing healthcare resource. Audiologists are doctoral level professionals trained to comprehensively evaluate hearing and communication difficulties. We are glad to guide you through each stage of your hearing journey.