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The New OTC Hearing Aid Law

On August 16, 2022, the U.S. Food and Drug Administration (FDA) issued a final rule to improve access to hearing aids which will in turn lower costs for millions of Americans suffering from hearing loss. This law establishes a new category for over-the-counter (OTC) hearing aids, enabling consumers with perceived mild to moderate hearing loss to purchase hearing aids directly from stores, online retailers, clinics and pharmacies without the need for a medical exam, prescription or a fitting adjustment issued by an audiologist.

OTC Hearing Aids. Licensed Consultion. Free Hearing Test
Pharmacist reviewing OTC Hearing Aid options.

Over 30 million adults in the U.S. could benefit from hearing aid use. “Today’s action by the FDA represents a significant milestone in making hearing aids more cost-effective and accessible,” said Health and Human Services Secretary Xavier Becerra. The Law has been imminent for some time, since in 2017 Congress passed the legislation with bipartisan support. The Biden Administration made the rule a priority for it to be implemented in conjunction with the passing of the Inflation Reduction Act.


As early as mid-October, consumers over the age of 18 will have the ability to purchase hearing aids over-the-counter. The rule is expected to lower the cost of hearings aids, stimulate competition and improve the accessibly to hearing care services and solutions. It is designed to assure the safety and effectiveness of OTC hearing aids while fostering innovation and competition in the hearing aid technology marketplace.


The specifications and criteria of what a hearing aid is are being defined, all with the consumer’s hearing health being a top priority. The central requirements are that the volume level must be able to be adjusted by the user, the amplification level is limited to prevent accidental ear damage, lowering the maximum sound output to reduce the risk of over-amplification, limiting the insertion depth of the device in the ear canal 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.


Specific information in hearing aid labeling is essential for consumers to identify conditions that either may pose a threat to health if left undiagnosed or avoid unnecessary and inappropriate hearing aid use. The consumer needs to review the label of the device and understand and claims the seller is making before making a purchase.


You may have seen Personal Sound Amplification Products (PSAPs) in stores or online, like Amazon. These are not alternatives to hearing aids. The FDA is aware of confusion in the marketplace when the consumer is considering a hearing aid or a PSAP to assist with their hearing loss.


Self Fitting. Self Testing. Hearing Aids. Medical Grade Hearing Aids.
AudixLife Hearing Aids. For Mild-to-Moderate Hearing Loss.

PSAPs are not intended to compensate for hearing loss and cannot be labeled as hearing aids. They are intended to accentuate sounds in specific listening environments. Examples of situations in which PSAPs typically are used include hunting, bird watching, listening to lectures with a distant speaker, and listening to soft sounds that would be difficult for normal-hearing individuals to hear. PSAPs are not intended to diagnose, treat, cure, mitigate, or prevent hearing loss


Currently, the average price of a pair of quality hearing aids costs over $3,500. A small percentage of this cost comes from the components, manufacturing and the cost of overhead. A large slice is associated with obtaining hearing aids and having them fitted by an audiologist. The new law should also remove the predatory and deceptive marketing and selling practices used by Audiologists and others to sell hearing aids. You also can’t rely on your health insurance to pick up the costs either. There is no hearing aid coverage through Medicare parts A or B.


While you may see “hearing aids” for as low as $99 on Amazon or through other online retailers, these haven’t passed through any serious medical muster. As great as the price may look, it’s probably too good to be true. Simply put, buyer beware. Before purchasing a pair of hearing aids, be sure to contact the seller to ensure their trustworthiness. Also inquire about their warranty, customer service and if they have licensed hearing specialists on staff.


RxHearing delivers a comprehensive suite of hearing care services to identify people who may be suffering from hearing loss and then offers them an affordable hearing aid solution. RxHearing provides free professional online hearing tests, evaluates via free licensed hearing care consultations, then ships medical-grade hearing aids directly to their customers. Saving them hundreds of dollars.


If you are suffering from hearing loss, seek advice from your primary physician.

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