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Patients experiencing mild to moderate hearing loss in the US could soon be able to buy hearing aids over-the-counter (OTC) without a medical exam or meeting with an audiologist, in line with new proposals from the Food and Drug Administration (FDA).

The proposed rule to establish an OTC category of hearing aids is designed to help increase competition in the market while ensuring the safety and effectiveness of OTC and prescription hearing aids. The rule is now up for 90 days of public comment.

An executive order made by President Joe Biden in July on promoting competition in the US economy called for the FDA to take steps toward allowing certain hearing aids to be sold without prescription.

The FDA said around 15% of US adults report some trouble hearing, but only a fifth of people who could benefit from a hearing aid use one. Barriers to use include access, social stigma, perceived value of the devices, certain state and federal regulations and cost.

Hearing aids sold OTC, the FDA says, would likely be less expensive than those currently sold on prescription, giving consumers greater choice at lower prices.

FDA acting commissioner Dr Janet Woodcock said: “The FDA’s proposed rule represents a significant step toward helping ensure that adults with mild to moderate hearing loss have improved access to more affordable and innovative product options.

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“The new regulatory category will provide the public with greater control over their hearing aid purchasing decisions at stores nationwide or online without the need for a professional hearing exam, fitting adjustment or a prescription.”

Campaigners and lawmakers alike have been calling for OTC hearing aids to be made available in the US for years. The FDA Reauthorization Act of 2017 actually states that the FDA “must categorize certain hearing aids as over-the-counter hearing aids and issue regulations regarding those hearing aids.” The law, however, has been followed by four years of inaction.

The FDA’s proposed rule would amend existing rules that apply to hearing aids for consistency with the new category, repeal the conditions for sale for hearing aids and address state regulation of hearing aids.

The OTC category would be applicable only to certain air-conduction hearing aids intended for adults aged 18 and older who have perceived mild to moderate hearing loss. Hearing aids for severe hearing loss or for users younger than 18 would still be prescription devices.

OTC devices would have a maximum volume limit to prevent the risk of injuries due to overamplification of sound. They would also be subject to device performance and design requirements, such as distortion control limits, self-generated noise limits and latency limits.

The range of frequencies that the devices can reproduce and how uniformly the OTC hearing aid amplifies different frequencies over its bandwidth would also be under certain restrictions, and the insertion depth of the devices would be limited.

If the rule is introduced, it will place some significant regulatory scrutiny on companies that aren’t approved to sell hearing aids but are essentially already doing so by marketing them as personal sound amplification products (PSAPs).

PSAPs are similar in appearance and function to hearing aids but are sold not as medical devices but as commercial sound boosters. They are often marketed as products that can help users within the normal range of hearing hear better in noisy environments like restaurants or crowded public places, but are often used by people experiencing hearing impairment.

For many US citizens they are established as an accessible alternative to acquiring an expensive hearing aid, and allow people experiencing hearing loss to bypass any formal medical intervention. With OTC hearing aids potentially coming onto the market, many PSAP manufacturers may find their products reclassified – or even obsolete.