The Food and Drug Administration said the new regulation cuts red tape by creating a new class of hearing aids that don’t require a medical exam, a prescription and other specialty evaluations. — The Associated Press
WASHINGTON — Millions of Americans will be able to buy hearing aids without a prescription later this fall, under a long-awaited rule finalized Tuesday.
The devices are intended for adults with mild to moderate hearing problems. The FDA estimates that nearly 30 million adults could potentially benefit from hearing aid use, but only about one-fifth of people with hearing problems use the devices currently. The FDA first proposed the rule last October. The new rule will take effect in mid-October.
Cost is a big obstacle now. Between the device itself and fitting services, Americans can pay more than $5,000 to get a hearing aid. Insurance coverage is very limited, and Medicare doesn’t pay for hearing aids, only diagnostic tests. 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.
Österreich Neuesten Nachrichten, Österreich Schlagzeilen
Similar News:Sie können auch ähnliche Nachrichten wie diese lesen, die wir aus anderen Nachrichtenquellen gesammelt haben.
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.
Weiterlesen »
Americans Will Be Able to Buy Over-the-Counter Hearing Aids This FallU.S. regulators have finalized a long-awaited rule that's expected to allow millions of Americans to buy hearing aids without a prescription.
Weiterlesen »
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.
Weiterlesen »
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
Weiterlesen »
FDA Finalizes Rule to Allow Over-the-Counter Hearing AidsThe FDA will allow people over the age of 18 with mild to moderate hearing loss to purchase hearing aids without a prescription. See potential bias and similarities in coverage from NBCNews, WSJ and dcexaminer: FDA HearingAids
Weiterlesen »