Introducing OTC Hearing Aids
First, let’s examine the new regulatory framework the FDA established. For the first time, all hearing aids will fall under two categories: prescription hearing aids and OTC hearing aids.
Prescription hearing aids will require a consumer to have a prescription for a hearing aid from a physician, audiologist or a licensed hearing instrument specialist.
The other – brand new – category of hearing aids will be available over-the-counter to people 18 and older with perceived mild-to-moderate hearing loss without the involvement of a licensed hearing care professional. These OTC hearing aids do not require a prescription.
This OTC category is further broken down into two types of products: self-fitting OTC hearing aids with a few preset settings that users can control either through an app or volume control wheel; and the second type, which is not self-fitting – basically an amplifier with volume control.
While the number of products in the marketplace may be limited initially, expect to see an increase in OTC hearing aids through the rest of 2022 into the first half of 2023.
The availability of the OTC devices is expected to increase awareness of hearing care in general and encourage more consumers to address their hearing health needs. These are vitally important goals. Approximately 40 million people have some degree of hearing loss, yet it is widely undiagnosed and untreated. In fact, of the 35 million Americans who could benefit from hearing aids, only one-third use them.¹