FDA unveils proposal for OTC hearing aids
WASHINGTON, Oct 20, (AP): Health regulators on Tuesday unveiled their proposal to allow Americans to buy hearing aids without a prescription, a long-awaited move intended to make the devices more accessible to millions of people with hearing problems.
The Food and Drug Administration said the proposed rule would cut red tape that currently requires hearing exams and a prescription for people with mild-to-moderate hearing loss. Under the plan, the devices could be ordered online or bought over-the-counter at pharmacies and other retail stores.
The move follows years of pressure from medical experts and consumer advocates to make the devices cheaper and easier to get.
More than 37 million Americans, or 15% of adults, have trouble hearing, according to the FDA, but only about one-fifth of people who can benefit from a hearing aid use one.
Cost is a big obstacle. 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.
US officials said Tuesday that the FDA change, when finalized, should spur competition and bring down prices.
“Today we open the door to an easier process and a more affordable process,” Health and Human Services Secretary Xavier Becerra told reporters.
The agency will take public comments on its proposal for 90 days before finalizing the new rules. FDA officials wouldn’t speculate on when new devices would actually hit store shelves.
Amplification
Consumer electronic companies for years have produced lower-cost “personal sound amplification” devices, but US regulations bar them from being marketed as hearing aids and they do not undergo FDA review. Regulators said Tuesday that the new rules will make explicit that those devices are not alternatives to FDA-vetted hearing aids. Companies that market them inappropriately could face federal penalties, such as fines or product seizures.
For their part, makers of hearing aids have long argued that professional expertise is required to pick the right device and adjust its settings to work properly.
Once the FDA rules take 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.
The looser regulations would not apply to devices for people with severe hearing loss or for children. Also, the agency said over-the-counter devices would be required to have volume limits and other measures to help prevent injuries.
Companies making over-the-counter hearing aids generally wouldn’t be required to conduct studies in people. Instead, they would submit applications to the FDA showing they met its standards for the devices.
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 by August 2020. The agency missed that deadline, in part due to the workload of the COVID-19 pandemic. Additionally, an executive order by President Joe Biden earlier this year set a timetable for the agency to take action no later than mid-November.
Salmonella: Federal health officials are rethinking their approach to controlling salmonella in poultry plants in the hope of reducing the number of illnesses linked to the bacteria each year, and on Tuesday the US Department of Agriculture announced several steps it plans to take to achieve that goal.
The USDA says the industry has succeeded in reducing the level of salmonella contamination found in poultry plants in recent years, but that hasn’t translated into the reduction in illnesses the agency wants to see.
Poultry is linked to roughly 23% of the 1.35 million salmonella infections in the US each year that lead to roughly 26,500 hospitalizations and 420 deaths, and those numbers haven’t changed much. Salmonella typically causes diarrhea, fever and stomach cramps, and severe cases require hospital care.
So the US Department of Agriculture plans to set up pilot projects to try changing the way it tests for salmonella in plants and to try encouraging the industry to do more on the farm to reduce the amount of bacteria on chickens before they enter the plant. The agency also plans to hold a series of meetings with industry officials and interested groups to discuss other ways to reduce the risk of salmonella illnesses.
“This is deeper, more targeted and more system-based approach than in the past,” Agriculture Secretary Tom Vilsack said. “The hope is that we can significantly reduce the risk of these serious cases and it’s certainly worth the effort.”
Currently, the USDA tests for the presence of salmonella on poultry at processing plants. One of the proposed pilot projects would add tests for the quantity of bacteria present and tests for the specific strains of salmonella that cause the most illnesses.
The agency also wants to encourage farmers to take a combination of steps proven to reduce bacteria in their chickens, including using more vaccinations, adding probiotics to feed and doing more to ensure that the birds’ bedding, food and water remain clean.
Solutions
The National Chicken Council trade group has said the industry has already invested millions of dollars in efforts to reduce salmonella contamination, including spraying germkilling solutions on raw chicken during processing, improving sanitation and using more vaccines. Spokesman Tom Super said many chicken farmers are already taking steps recommended by the USDA.
“We pledge to continue to do our part — the industry will remain committed to investing significant resources — at the hatchery, feed mill, farm and plant — to further enhance the safety profile of chicken products. But there is no law, regulation or silver bullet that will make raw chicken a 100% sterile product,” said Ashley Peterson, the trade group’s senior vice president of scientific and regulatory affairs.
The USDA said 89% of the nation’s poultry processing plants are now meeting the agency’s performance standard for limiting salmonella in chicken parts. That is up from three years ago when only 71% of the plants met the standard.
National Turkey Federation President Joel Brandenberger said the industry already shares ideas about the best ways to control salmonella so the companies look forward to participating in the USDA roundtables.
”Because there are no simple solutions, improving food safety requires the type of collaborative approach USDA is advocating,” Brandenberger said.
Zach Corrigan of Food and Water Watch, an advocacy group that supports stricter food safety regulations, said it sounds like the USDA’s new efforts are “a move in the right direction” but he still hopes the agency will do more to control salmonella by declaring that meat found to have the bacteria can’t be sold to consumers.
Currently, it is legal to sell raw chicken with salmonella bacteria on it, which is why health officials stress the need for safe handling of raw poultry, including thoroughly cooking the meat to kill potential germs. They also warn people should not rinse raw chicken, which can spray bacteria everywhere.
Brian Ronholm, a former USDA under secretary for food safety who now oversees food policy for Consumer Reports, praised the federal agency’s comprehensive approach to reducing salmonella illnesses.