The FDA hopes to revolutionize the hearing aid marketplace. Its new rules would allow over-the-counter hearing aids to be sold directly to consumers. Manufacturers could even sell the devices online without the involvement of an audiologist or an otolaryngologist.
Who Will Benefit from Over-the-Counter Hearing Aids?
Until now, hearing aids have been available only by prescription, with a few exceptions. Consequently, they have been very pricey. With this change in regulation, the devices should become both more available and easier to afford.
Tens of millions of Americans suffer from mild to moderate hearing loss. Until now, many did not consider using hearing aids because they are so expensive. Each device can cost thousands of dollars and insurance companies usually do not cover them. As a result, only about 20% of those who could benefit actually use listening assistance devices. The proposed rule should make it far easier for people to find and afford appropriate hearing aids.
People with severe hearing impairment and those under 18 would still need to consult a professional. Over-the-counter hearing aids are not intended for children or people with significant deafness.
The Objectives of the New Rule:
The FDA intends the new rule to increase competition in the hearing aid marketplace. If this results in greater accessibility and affordability, more people should be able to use hearing aids. Other barriers to adoption, such as social stigma, may not disappear quickly, though. On the other hand, over-the-counter hearing aids and Personal Sound Amplification Products are often less visible than Bluetooth mobile phone earpieces.
We have been anticipating this change for a few years. You may wish to listen to our interviews on the topic. They include Show 1108: Surprising Solutions to Help You Hear Better and Show 1261: Overcoming Hearing Loss.