Over-the-counter hearing aids are a new category of FDA-regulated devices. In general, OTC hearing aids are meant to make general hearing care more affordable. OTC hearing aids will be an alternative to today’s FDA-regulated hearing aids, which are currently only available from hearing health professionals, such as audiologists and hearing aid specialists. The audiologist fits you for the hearing aid, adjusts the device based on your hearing loss, and provides additional follow-up services. Those with any degree of hearing loss should know if they are a good fit for these OTC hearing aids.
Why make hearing aids OTC?
Hearing aids today, on average, cost $4,500. OTC hearing aids offer a lower-cost alternative to customers, making hearing care more accessible to the general public. To ensure patient safety, the proposed rule addresses design and performance requirements such as a maximum output (volume) limit that would prevent injuries from the overamplifying sound.
Am I a good candidate?
OTC hearing aids will be for adults who believe they have mild-to-moderate hearing loss, even if they have not had a hearing exam. For those seeking great medical-grade hearing aids at the best possible prices with the ability to do everything from the comfort of your home, this approach may be the right one for you.
