FDA Approves Sale of OTC Hearing Aids Making Them More Affordable

"The?FDA?can?change,?transform?or?create?new industries at the stroke of the pen. Its a responsibility we take very seriously. The rule and announcements made today are a good example of this at work. Todays announcement will make it much easier to access and use innovative and effective hearing-aids for all people who suffer from mild to moderate hearing loss."

Vid Desai, Chief Information Officer, FDA

This week the FDA established a new regulatory category for over-the-counter (OTC) hearing aids and updated the regulatory framework for hearing aids. This new ruling is important because it will improve access and lower the cost of hearing aids making them more affordable for millions of Americans. Over 37 million people in the US could benefit from using hearing aids but many are unable to buy them because they are too expensive. This rule aims to stimulate competition and facilitate the sale of safe and effective OTC hearing aids that are more assessable and less expensive than current options.?

Prior to this week's action, getting a hearing aid was an involved and expensive process. People were required to make an appointment with a specialist and have a medical exam, get a prescription for a hearing aid, then they were required to make another appointment with an audiologist to fit the hearing aid and make adjustments. Many people could not afford to pay for the two exams and the hearing aid.

The new rules enable people to purchase hearing aids directly from stores and online retailers without the need for a medical exam, prescription, or a fitting adjustment by an audiologist.?People will be able to buy OTC hearing aids in traditional retail and drug stores as soon as mid-October when the new rule takes effect.

Hearing Loss Linked To Dementia and Falls

Hearing loss strains the brain. Brain scans show that hearing loss may contribute to a faster rate of atrophy in the brain. According to a 2020 Lancet Commission report, hearing loss is one of the top risk factors for dementia. Research from Johns Hopkins shows that hearing helps with balance and links hearing loss with walking problems and falls.?The Johns Hopkins researchers also found that mild hearing loss doubled dementia risk. Moderate loss tripled risk, and people with a severe hearing impairment were 5 times more likely to develop dementia. Hearing aids may reduce the risk of falls and dementia.

Over 1000 Public Comments

The FDA finalized the rule after receiving and reviewing more than 1,000 public comments on the proposed rule issued on October 20, 2021. Comments submitted by consumers, professional associations, hearing aid manufacturers, public health organizations and advocacy groups, members of Congress, state agencies, and other stakeholders are summarized in the final rule, along with the FDA’s respective responses.

The OTC category established in this final rule applies to certain air-conduction hearing aids intended for people 18 years of age and older who have perceived mild to moderate hearing impairment. Hearing aids that do not meet the requirements for the OTC category (for example, because they are intended for severe hearing impairment or users younger than age 18) will continue to require a prescription.?

“Hearing loss is a critical public health issue that affects the ability of millions of Americans to effectively communicate in their daily social interactions. Establishing this new regulatory category will allow people with perceived mild to moderate hearing loss to have convenient access to an array of safe, effective and affordable hearing aids from their neighborhood store or online.”??

Robert M. Califf, MD, FDA Commissioner

In response to public comments and to assure the safety and effectiveness of OTC hearing aids, the final rule incorporates several changes from the proposed rule, including lowering the maximum sound output to reduce the risk to hearing from over-amplification of sound, revising the insertion depth limit in the ear canal, requiring that all OTC hearing aids have a user-adjustable volume control, and simplifying the phrasing throughout the required device labeling to ensure it is easily understood. The final rule also includes performance specifications and device design requirements specific to OTC hearing aids.

Hearing Stats

• 37 million American adults report trouble hearing
• Age is the strongest predictor of hearing loss among adults with the greatest amount of hearing loss in the 60 to 69 age group.
• Men are almost twice as likely as women to have hearing loss among adults aged 20-69.
• Non-Hispanic white adults are more likely than adults in other racial/ethnic groups to have hearing loss.
• Non-Hispanic black adults have the lowest prevalence of hearing loss among adults.
• 8% of people aged 55 to 64 have disabling hearing loss.
• 25% of people aged 65 to 74 have disabling hearing loss.
• 50% of people 75 and older have disabling hearing loss.
• Over 37 million people in the US could benefit from using hearing aids.
• Among adults aged 70 and older with hearing loss who could benefit from hearing aids, fewer than 30% has ever used them.
• Among adults aged 20 to 69 who could benefit from wearing hearing aids fewer than 16% have ever used them.
• As of December 2019 about 736,900 cochlear implants have been implanted worldwide.
• In the United States about 118,100 cochlear implants have been implanted in adults and 65,000 in children.

Source: NIH

Image source: FDA

Subscribe and Comment

I'm interested in your feedback - please leave your comments. To subscribe please click subscribe at the top of this article.

Copyright ? 2022 Margaretta Colangelo. All Rights Reserved.

This article was written by?Margaretta Colangelo.?Margaretta is Co-founder of Jthereum. She serves on the advisory board of the AI Precision Health Institute at the University of Hawai?i?Cancer Center. She's based in San Francisco?

Twitter?@realmargaretta