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.
Brasil Últimas Notícias, Brasil Manchetes
Similar News:Você também pode ler notícias semelhantes a esta que coletamos de outras fontes de notícias.
Over-the-counter hearing aids expected this fall in USMillions of Americans will be able to buy hearing aids without a prescription later this fall, under a long-awaited rule finalized Tuesday.
Consulte Mais informação »
FDA green lights over-the-counter hearing aidsPeople will soon be able to buy hearing aids over the counter, without a medical exam, prescription or fitting.
Consulte Mais informação »
Millions of Americans will soon be able to buy hearing aids without a prescriptionAdults with perceived mild to moderate hearing impairment will be able to buy hearing aids directly from stores, pharmacies and online retailers — no prescription or doctor's appointment required — as soon as mid-October.
Consulte Mais informação »
FDA: Hearing aids will be available to purchase over-the-counter starting mid-OctoberIt will soon be easier, and potentially cheaper, to buy hearing aids. Tuesday, the FDA announced Americans will be able to purchase the devices over the counter. KevRincon reports you could see them on store shelves starting in mid-October.
Consulte Mais informação »
Over-the-Counter Hearing Aids Could Be Available by October, FDA AnnouncesFDA Paves Way for Over-the-Counter Hearing Aids to Be Available as Soon as October
Consulte Mais informação »