F.D.A. paves the way for the sale of over-the-counter hearing aids
Agency action opens door to cheaper, more accessible devices without a prescription or medical exam.
The Food and Drug Administration decided on Tuesday to allow over-the-counter and non-prescription hearing aids to be sold to adults, a wish long sought by consumers frustrated with expensive exams and devices.< /p>
The high cost of hearing aids, which are not covered by basic health insurance, has discouraged millions of hearing-impaired Americans from purchasing these devices. Health experts say untreated hearing loss can contribute to cognitive decline and depression in older adults.
Under the new rule, people with mild to moderate hearing loss should be able to buy hearing aids online and in retail stores as early as October, without having to visit a doctor for an exam to get a prescription.
The F.D.A. cited studies estimating that about 30 million Americans suffer from hearing loss, but only about a fifth of them receive help. The changes could upend the market, which is dominated by a relatively small number of manufacturers, into a larger field with cheaper and possibly more innovative designs. Current hearing aid costs, which typically include visits to an audiologist, range from around $1,400 at Costco to around $4,700 elsewhere. Nicholas Reed, audiologist in the Department of Epidemiology at the Johns Hopkins Bloomberg School of Public Health. “We don't know what these companies might offer. We could literally see new ways hearing aids work, what they look like. »
The F.D.A. takes effect in 60 days. Industry officials say device makers are largely ready to launch new products, though some may need time to update labeling and packaging or comply with technical details. of the ruler.
Dr. Robert Califf, the F.D.A. commissioner, said the move was intended to "unleash the power of American industry" in a way that could have global influence.
"Hearing loss has a profound impact on everyday communication, social interaction, and the overall health and quality of life of millions of Americans," Dr. Califf said at a press briefing on Tuesday. "It's a huge global problem. where I believe American ingenuity can make a huge difference."
The White House also hailed the decision as a milestone achievement for President Biden, who is also expected to signing the Cut Inflation Act on Tuesday. The change eliminates the requirement to see an audiologist for a hearing test and fitting, a process rarely covered by hearing aid insurance. Brian Deese, Director of the Council national economy in the White House, said that e change was a "top priority" for the president. difference in the lives of millions of Americans,” said Deese.
Hearing loss is associated with cognitive decline, depression, isolation and to other health problems in the elderly. Yet barriers to getting a hearing aid include costs that are not covered by Medicare. There's also the stigma - like appearing "old" - that comes with use.
Appreciation of the importance of fine hearing for adults is also offbeat: A recent survey found that people between the ages of 50 and 80 were twice as likely to plan to take their pet to the vet in the next year than to have their hearing checked.
>"This kinda breaks my heart," said Sarah Sydlowski, Associate Chief i...
Agency action opens door to cheaper, more accessible devices without a prescription or medical exam.
The Food and Drug Administration decided on Tuesday to allow over-the-counter and non-prescription hearing aids to be sold to adults, a wish long sought by consumers frustrated with expensive exams and devices.< /p>
The high cost of hearing aids, which are not covered by basic health insurance, has discouraged millions of hearing-impaired Americans from purchasing these devices. Health experts say untreated hearing loss can contribute to cognitive decline and depression in older adults.
Under the new rule, people with mild to moderate hearing loss should be able to buy hearing aids online and in retail stores as early as October, without having to visit a doctor for an exam to get a prescription.
The F.D.A. cited studies estimating that about 30 million Americans suffer from hearing loss, but only about a fifth of them receive help. The changes could upend the market, which is dominated by a relatively small number of manufacturers, into a larger field with cheaper and possibly more innovative designs. Current hearing aid costs, which typically include visits to an audiologist, range from around $1,400 at Costco to around $4,700 elsewhere. Nicholas Reed, audiologist in the Department of Epidemiology at the Johns Hopkins Bloomberg School of Public Health. “We don't know what these companies might offer. We could literally see new ways hearing aids work, what they look like. »
The F.D.A. takes effect in 60 days. Industry officials say device makers are largely ready to launch new products, though some may need time to update labeling and packaging or comply with technical details. of the ruler.
Dr. Robert Califf, the F.D.A. commissioner, said the move was intended to "unleash the power of American industry" in a way that could have global influence.
"Hearing loss has a profound impact on everyday communication, social interaction, and the overall health and quality of life of millions of Americans," Dr. Califf said at a press briefing on Tuesday. "It's a huge global problem. where I believe American ingenuity can make a huge difference."
The White House also hailed the decision as a milestone achievement for President Biden, who is also expected to signing the Cut Inflation Act on Tuesday. The change eliminates the requirement to see an audiologist for a hearing test and fitting, a process rarely covered by hearing aid insurance. Brian Deese, Director of the Council national economy in the White House, said that e change was a "top priority" for the president. difference in the lives of millions of Americans,” said Deese.
Hearing loss is associated with cognitive decline, depression, isolation and to other health problems in the elderly. Yet barriers to getting a hearing aid include costs that are not covered by Medicare. There's also the stigma - like appearing "old" - that comes with use.
Appreciation of the importance of fine hearing for adults is also offbeat: A recent survey found that people between the ages of 50 and 80 were twice as likely to plan to take their pet to the vet in the next year than to have their hearing checked.
>"This kinda breaks my heart," said Sarah Sydlowski, Associate Chief i...
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