FDA creates new category of OTC hearing aids, issues PSAP guidance

Regulatory NewsRegulatory News
| 16 August 2022 | By Ferdous Al-Faruque 

After pressure from the Biden Administration, the US Food and Drug Administration finalized a much-anticipated rule that allows certain air conduction hearing aids to be available over-the-counter (OTC) without the need for hearing exams or fittings. At the same time, the agency also published a final guidance on personal sound amplification products that clarifies how they are different from hearing aids.
On 16 August, FDA announced a final rule that removes significant oversight of certain hearing aids and allows consumers to buy them without a prescription by creating a new OTC hearing aid category.
In 2017, Congress passed the bipartisan Over-the-Counter Hearing Aid Act, which mandated that FDA create a new category of OTC hearing aids, but the agency has taken years to implement the necessary regulation to do so. President Biden issued an Executive Order in July 2021 setting a 120-day deadline for FDA to issue a proposed rule on the matter. (RELATED: FDA issues proposed OTC hearing aid rule, Regulatory Focus 19 October 2021)
The OTC hearing aid final rule sets out the regulatory requirements that hearing aids need to meet to be included in the new category. It also updates current rules by relaxing the conditions for allowing the sale of OTC hearing aids and addresses certain state regulations for the devices.
The rule only applies to certain air conduction hearing aids for adults who have mild to moderate hearing loss. Air conduction hearing aids are worn inside the ear or over the ear with components reaching into the ear to amplify sound.
The rule also sets certain limits on maximum volume the devices are allowed to output to prevent further hearing loss and they must meet certain device performance and design requirements that include limits on sound distortion, delay and range of output frequencies. The final rule also sets limits on how far the hearing aid can go into the ear canal to prevent injury and sets labeling requirements to ensure consumers know the limitations of their device and how to report adverse events.
In their rule, FDA notes that it has either accepted or declined several changes made by stakeholders in response to the proposed rule. For instance, it changed the maximum volume the devices are allowed to emit after getting stakeholder feedback. (RELATED: Stakeholders split over FDA’s contentious proposed rule for OTC hearing aids, Regulatory Focus 27 January 2022)
“We are finalizing lower output limits than we proposed,” said FDA. “The general limit will be 111 decibels of sound pressure level (dB SPL), with 117 dB SPL allowable for devices while input-controlled compression is activated.”
The agency also said it is declining to set a gain limit, has revised the allowable insertion depth of the device, will not require age verification of customers, has improved phrasing on the labeling to make it more readable, will not require measurements of hearing loss to qualify for purchase, will not require the devices be self-fitting and will continue to require the devices meet quality management system requirements.
At the same time as FDA published its final OTC hearing aid rule, it also published a final guidance titled “Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products.” While hearing aids and PSAPs often look very similar and work in the same way, the guidance delineates when a PSAP will be considered a hearing aid and hence have to meet more stringent regulatory requirements.
PSAPs are meant for use by people with normal hearing to help amplify sound in certain recreational situations such as hunting, bird watching and listening to lectures. More specifically, FDA says PSAPs “are not intended to diagnose, treat, cure, mitigate, or prevent disease and are not intended to affect the structure or function of the body.”
“A lack of clarity between PSAPs and hearing aids has contributed to stakeholder and consumer confusion,” the agency added. “This guidance is intended to describe hearing aids, PSAPs, their respective intended uses, and the regulatory requirements that apply to both types of products.”
During a press briefing after announcing the rule and guidance, Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, noted that while hearing aids and PSAPs both amplify sound for the user, the latter are not intended to compensate for impaired hearing.
“The FDA has worked diligently to draft and finalize these regulations in the midst of its unprecedented efforts to address the COVID-19 pandemic and monkeypox public health emergency,” he said. “Issuing the rule has been a primary focus for the FDA, and the agency has worked to ensure that the appropriate safeguards are in place to make over-the-counter hearing aids a safe and effective option for consumers.”
"It's our belief that these two actions will help encourage additional innovation in the field of hearing aid technology,” Shuren added. “Consumers will soon be able to purchase over-the-counter hearing aids from a wider variety of retailers as more options for hearing aid models are available to them at potentially lower costs."
Kate Carr, president of the Hearing Industries Association, supported FDA’s final rule but also recommended consumers still see hearing professionals to figure out the extent of their hearing loss and find the best solution.
“This is a significant step forward for the millions of Americans who suffer hearing loss yet are untreated,” she said in a statement. “Hearing loss is unique to each person, and most do not know if their condition is mild, moderate, or greater, caused by another medical issue or something as simple as ear wax.”
The industry lobby group recommended when consumers buy an OTC hearing aid, they should keep their receipts and understand the warrant policy in case the device isn’t right for them, and they need to return it.
During the press briefing with Shuren, FDA Commissioner Robert Califf, said he was “particularly excited” about the new OTC hearing aid rule and recalled getting a call from the Obama White house during his previous commissionership to work on the rule in 2016.
“This rule is the result of years of work and engagement with the communities affected and involved with hearing loss,” he said. “It's nice to see the work coming to such a good result.”
He noted that about 30 million American adults have some trouble hearing which can significantly impact their communication with others, personal relationships, school or work performance, and emotional health. He also said that despite the high prevalence of hearing loss and public health impact, only about one out of five people who could benefit from a hearing aid are currently using one.
“Today's action will not only help adults who have perceived mild to moderate hearing loss gain access to more affordable and innovative product options, but we expect that it will unleash the power of American industry to improve the technology in a way that will impact the enormous burden of disability from hearing loss affecting the world,” said Califf.
While the final rule won’t into effect for another 60 days, he expects a rush of new OTC hearing aids hitting shelves as early as mid-October.


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