FDA proposes rule to make hearing aids available over the counter
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The FDA has proposed a rule that would allow some hearing aids to become available over the counter, and thus, make them potentially more affordable and accessible.
CDC data indicate that 15.9% of U.S. adults and five of every 1,000 children aged 3 to 17 years have some type of hearing loss.
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“For those who have experienced mild or moderate hearing loss, this is going to be great news for you,” HHS Secretary Xavier Becerra said during a conference call with reporters. “Equally important is that [this proposed rule] allows us to put hearing devices more in reach of communities that have often been left out, such as communities of color and the underserved who have typically traditionally lacked access to hearing aids.”
According to documents issued by the FDA, the proposed rule calls for:
- some hearing aids to be sold at brick-and-mortar stores or online without the need for a medical exam or fitting performed by an audiologist;
- over-the-counter hearing aids to contain limits on audio volume, distortion control, self-generated noise, latency and the insertion depth of the devices;
- requirements regarding the range of frequencies that over-the-counter hearing aids can reproduce and how uniformly they amplify different frequencies over bandwidth; and
- packaging labels that state the devices should only be used by individuals aged 18 years or older, symptoms of perceived mild-to-moderate hearing loss, possible reasons for seeing a health care professional for hearing issues and warnings about signs and symptoms that “should prompt a consultation with a licensed physician (preferably an ear specialist).”
The FDA simultaneously issued draft guidance regarding the regulatory requirements for hearing aid devices as well as personal sound amplification products, or PSAPs. In a press release, the agency said the draft guidance provides descriptions for these items, discusses their purpose and allows for “further clarification regarding the differences between PSAPs, which help people with normal hearing amplify sounds, and hearing aids and to inform consumers that PSAPs are not considered OTC alternatives for hearing aids.”
“It’s our belief that these two things will help encourage additional innovation in the field of hearing aid technology,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said during the conference call. “The proposal will allow consumers to purchase over-the-counter hearing aids from a wider variety of retailers with more options and hearing aid models available to them, and potentially lower costs by improving access to safe, effective and potentially more affordable over-the-counter hearing aid options.”
Comments on the proposed rule and draft guidance will be accepted until Jan. 18 on the Federal Register.
References
Blackwell DL, Norris T. MMWR Morb Mortal Wkly Rep. 2017;doi:10.15585/mmwr.mm6650a7.
CDC. Data and statistics on hearing loss in children. https://www.cdc.gov/ncbddd/hearingloss/data.html. Accessed Oct. 21, 2021.
FDA issues landmark proposal to improve access to hearing aid technology for millions of Americans. https://www.fda.gov/news-events/press-announcements/fda-issues-landmark-proposal-improve-access-hearing-aid-technology-millions-americans. Published Oct. 19, 2021. Accessed Oct. 21, 2021.
Medical Devices; Ear, nose and throat devices; Establishing over-the-counter hearing aids. https://www.federalregister.gov/documents/2021/10/20/2021-22473/medical-devices-ear-nose-and-throat-devices-establishing-over-the-counter-hearing-aids. Published Oct. 20, 2021. Accessed Oct. 21, 2021.
FDA. Regulatory requirements for hearing aid devices and personal sound amplification products /draft guidance for industry and FDA staff. https://www.fda.gov/media/87330/download. Published Oct. 20, 2021. Accessed Oct. 21, 2021.
Perspective
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Michael McKee, MD
This proposed rule is an excellent idea.
In the long term, this rule was needed to help try to move the needle that would allow for, especially those with mild- to moderate-hearing loss, the ability to acquire these types of devices. In the short term, there will be workflow issues and some confusion among patients regarding what is a mild- to moderate-hearing loss compared with a severe hearing loss. However, a professionally administered audiogram can help answer that question.
In terms of the impact on audiology, this is probably more of a mixed bag for them. Although there are probably some concerns among audiologists regarding how they will bill for services and keep their clinics going, a lot of those concerns will probably not pan out.
University of Michigan
Perspective
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Jeffrey P. Regan, MA
The American Speech-Language-Hearing Association, or ASHA, appreciates the release of this long-anticipated rule.
We note from an initial review that the FDA has proposed several provisions that do not align with expert consensus recommendations that ASHA made in collaboration with a wide variety of external stakeholders in 2018.
ASHA remains committed to advocating that OTC hearing aids meet key technical specifications, especially related to gain and output levels, that ensure their safe utilization by individuals with self-perceived mild to moderate hearing loss. We also remain committed to advocating that these devices are appropriately marketed only to individuals who are 18 years of age and older and that anyone with any degree of self-perceived hearing loss be encouraged to consult with a certified audiologist or hearing health care professional.
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