Hearing Aid Articles

Acquiring hearing aids was previously a fairly difficult and lengthy process with requirements that could deter many who needed hearing aids from getting them. Last Tuesday, October 19th, the FDA released a proposal for new rules to officially categorize over-the-counter (OTC) hearing aids. This new proposal has actually been in the works for quite some time - its postponement was another casualty of the recent COVID-19 pandemic. The FDA document, titled “Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids,” covers specific labeling/packaging requirements and electroacoustic device regulations for OTC hearing aids in efforts to make it easier and safer for consumers to purchase these devices, as well as foster an environment for more market competition by also making it easier for new hearing aid manufacturers to enter the fold. This effort follows President Joe Biden’s Executive Order on Promoting Competition in the American Economy that was signed in early July of this past year.
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