U.S. regulators have finalized a long-awaited rule that's expected to allow millions of Americans to buy hearing aids without a prescription.
The new over-the-counter status won't apply to devices for more severe hearing loss, which will remain prescription only.
Consumer electronic companies for years have produced lower-cost “personal sound amplification” devices, but U.S. regulations bar them from being marketed as hearing aids and they do not undergo FDA review. The new rule makes explicit that those devices are not alternatives to FDA-vetted hearing aids. Companies that market them inappropriately could face penalties, such as fines or product seizures.
The FDA said it changed several parts of its initial proposal in response to public comments, including clarifying how the federal rule will impact state regulations on hearing aids. Once the federal rule takes effect, traditional manufacturers are expected to begin selling cheaper, direct-to-consumer models. Eventually, advocates predict the hearing aid market will resemble eye care, where consumers can choose between drugstore reading glasses or prescription bifocals.
Tuesday’s announcement follows prodding from medical committees and Congress, which in 2017 instructed the agency to lay out a plan for over-the-counter hearing devices.
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