The Food and Drug Administration has taken another step toward creating a category for over-the-counter hearing aids to be sold directly to consumers or online without the need for a clinical exam.
Its proposed rule, announced Tuesday, would allow adults with perceived mild to moderate hearing loss to obtain certain air-conduction hearing aids without a prescription. It also address patient safety, with guidance on maximum volume, device performance and design requirements such as insertion depth. In addition, the agency has updated its consumer guidance on hearing aids, personal sound amplification products and the proposed changes to obtaining the products.
Adults and children with severe hearing loss would continue to require a prescription under the rule.
Federal officials have been inching toward a final rule since the passage of the Over-the-Counter Hearing Aid Act of 2017. The intent of the new proposal is to promote competition among hearing aid manufacturers (the market currently is controlled by four companies) and reduce cost barriers for consumers, the administration said in a statement.
Benefit to LTC uncertain
Whether a final rule would benefit long-term care residents is uncertain. Costs may certainly be a concern, but removing an audiologist from the process of acquiring hearing aids may backfire, according to a study from 2019.
Only about one-fifth of people who could benefit from a hearing aid use one, and those numbers may be lower in long-term care. Investigators found that people who are dually eligible for both Medicare and Medicaid have about 41% lower odds of using hearing care services. They were also twice as likely to report having trouble hearing with their devices when compared to high-income Medicare beneficiaries.
Separating hearing aid purchases from a healthcare encounter may exacerbate those concerns, the authors wrote. But one of their proposed solutions — hiring a staff audiologist — may be beyond the reach of many facility budgets.
