Comments on the FDA’s proposed creation of an over-the-counter hearing aid category have exposed flaws in the audiology industry. Manufacturers, backed by trade bodies or lawmakers, are lining up on opposite sides of a debate over core aspects of the agency’s proposal.
In 2017, legislators led by the FDA to create a new category of over-the-counter hearing aids for adults with perceived mild to moderate hearing loss. The FDA followed in October 2021 with the publication of a proposed rule regarding the establishment of a category of over-the-counter hearing aids. The proposal paved the way for hearing aids to be sold directly to consumers in stores or online without a medical exam or fitting by an audiologist, while maintaining prescription-only status for minors and severe hearing loss. .
FDA has received more than 1,000 comments on the proposal, including many from individuals who filed nearly identical submissions detailing concerns about the proposed maximum sound pressure level in decibels (dB). The proposed amplification limit of 120 dB is higher than the output limit of 110 dB proposed by groups including the Academy of Doctors of Audiology (ADA).
The agency justified its proposed amplification limit of 120 dB by requiring devices to have input-controlled compression and user-adjustable volume control. According to the FDA, the features mean users would have “sufficient time to take appropriate action to mitigate unacceptable sound levels,” such as lowering the volume, removing the device, or moving to a quieter environment. The American Academy of Audiology (AAA) criticized the FDA plan.
“Abundant evidence related to noise-induced hearing loss indicates that individuals do not know when sound is potentially harmful and do not take steps to reduce their exposure. Furthermore, the vast majority of people with hearing loss who will be the main consumers of these types of devices are aging adults and may have multiple comorbidities that prevent them from taking expected mitigation measures to reduce uncomfortable or potentially damaging loud sound levels,” said the audiologists have written.
The reactions contrast with the opinions put forward by some manufacturers and legislators. Audio equipment maker Bose, which sparked the creation of the FDA’s self-adjusting hearing aid category in 2018 with its De Novo application, provided the most detailed rebuttal the case of audiologists to limit the output of OTC hearing aids to 110 dB.
According to Bose, “there is no clear scientific consensus on what the maximum output limits of hearing aids should be” and some parts of the process ADA, AAA and other hearing care associations used to calculate the ceiling of 110 dB is “incorrect and reflects a fundamental misunderstanding.”
Senators Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa), in their joint comments submitted to the FDA, expressed support for maintaining the upper limit of 120 dB.
Bose significantly increased its political contributions during the 2020 election cycle, distributing more money than in the previous 13 election cycles combined. Yet Bose’s political contributions were still overshadowed by those of Starkey Hearing Technologies, a historic player in the prescription-only hearing aid market. During the 2020 election cycle, Starkey Contributions reached nearly $1.7 million, more than 10 times Bose’s spending. Starkey, a big spender in the 2018 cycle, has already donated $700,000 in the 2022 cycle.
Starkey used the FDA’s comment process to Raising concerns with the “hybrid surveillance model” planned by the agency. According to the hearing aid manufacturer, the model falls short because it “mixes the requirements of medical devices with controls more appropriate to consumer technology.” Starkey added that “the lightweight approach proposed for the app would do little to deter non-compliance from manufacturers and sellers, increasing the risk of over-the-counter hearing aid use by unintended users.” and aggravating the weaknesses of this hybrid model”. The manufacturer is also pushing for an overall output limit of 110 dB.
In addition to central disagreements, manufacturers, professional bodies and state attorneys general called on the FDA to revise its proposals to avoid several points of potential confusion. Some comments from different organizations are contradictory.
Bose has pushed back against the FDA’s proposal that the packaging of over-the-counter hearing aids will contain details of the manufacturer’s return policy. The company argued that the seller’s return policy will apply and, as such, disclosure of the manufacturer’s policy on the outer packaging may be “confusing and even misleading to consumers purchasing the device from third-party vendors”.
In contrast, the Federal Trade Commission called the proposal “an inexpensive addition” that can “help alleviate confusion about return policies.”
Other groups disagreed on the extent to which federal requirements should supersede existing state exemptions. Warren, Grassley and the FTC expressed support for preempting conflicting state laws and regulations, with the latter saying it means the proposal is likely to promote “pro-competitive benefits.”
However, the National Association of Attorneys General is worried the proposal will repeal virtually all exemptions sought by the state, causing “unnecessary confusion and the potential for unnecessary litigation.”
The FDA will now work to finalize the rule. It is not known how long it will take for the agency to adopt its final text. The rule will come into effect 60 days after the publication of the final rule.