OTC hearing aids performed nearly as well as prescription devices, but not yet legal for sale
In a highly controlled comparison study, several over-the-counter hearing assistance devices performed almost as well as a conventional hearing aid that cost thousands of dollars more.
Three of five selected personal sound amplification products (PSAP) were found to improve speech understanding among participants with mild-to-moderate hearing loss to a degree that was comparable to results obtained with a hearing aid, Nicholas Reed, AuD, of Johns Hopkins School of Medicine, and colleagues wrote in the July 4 issue of JAMA.
Congress is currently considering rare, bipartisan legislation that would allow these devices to be marketed as direct-to-consumer products subject to FDA regulation. At present, hearing aids can only be purchased through a licensed hearing specialist.
Hearing aids for both ears typically cost around $4,500, while PSAPs cost several hundred dollars or less.
The Over-the-Counter Hearing Aid Act of 2017 is being sponsored in the Senate by Elizabeth Warren (D-Mass.) and Charles Grassley (R-Iowa) and in the House by Joseph Kennedy (D-Mass.) and Marsha Blackburn (R-Tenn.).
Reed told MedPage Today that the study findings lend support to the creation of the new regulatory classification for hearing aids.
“Some of these devices did about as well as the hearing aid in our controlled environment, suggesting that some PSAPs are pretty good,” he said. “Perhaps we should support the movement to get these in the hands of more people and to regulate them to improve the quality of the products.”
Klobuchar said she will also introduce legislation in January to provide the FDA with new tools to deal with potential drug shortages.
Pharmacists and health care providers are reporting an “unprecedented” shortage of prescription drugs, especially for chemotherapy. The FDA currently lists 150 “medically necessary” drugs that are in short supply, which is double the number from five years ago.
Earlier this month, Klobuchar sent a letter to FDA Commissioner Margaret Hamburg, requesting “immediate action” to ensure adequate supplies of essential drugs.
Klobuchar noted that medications in short supply include everything from morphine for pain relief to propofol for sedation to leucovrin for cancer. There is also a serious shortage of pre-filled epinephrine syringes used in emergencies to treat heart attacks and allergic reactions
Experts cite a number of factors behind the shortages, including scarcity of some raw materials, manufacturing problems and unexpected demand. Business decisions within the pharmaceutical industry are also a factor, such as cutting back on production of low-cost generic drugs in favor of more profitable brand-name drugs.
“Physicians, pharmacists and patients are currently among the last to know when an essential drug will no longer be available,” said Klobuchar. “That’s not right. There needs to be better coordination between the pharmaceutical industry, the FDA and health care providers so patients don’t lose access to the medications they depend on.”
Klobuchar said she plans to introduce legislation next month to provide the FDA with better tools to address potential drug shortages in the future.
Specifically, Klobuchar said her legislation would give the FDA the authority to require early notification from pharmaceutical companies when they decide to limit or discontinue production of prescription drugs.
Klobuchar also said that when there is an impending shortage of a drug, the FDA should have the authority to establish an expedited process to approve substitute treatments or the importation of safe, clinically-equivalent drugs from outside the United States.
“We want to respect the private market, but we also need to protect the public’s health,” said Klobuchar. “This is a common-sense solution. It’s not too much to ask to have an early warning system so pharmacists and physicians can prepare in advance and ensure that patients continue to receive the best care possible.”
Food facilities now required to report potentially dangerous products
The U.S. Food and Drug Administration has a new way to head off potential cases of foodborne illness – the Reportable Food Registry (RFR), where food industry officials must use to alert the FDA quickly, through an electronic portal when they find their products might sicken or kill people or animals. The requirement, a result of legislation, took effect with the launch of the portal.
Facilities that manufacture, process or hold food for consumption in the United States now must tell the FDA within 24 hours if they find a reasonable probability that an article of food will cause severe health problems or death to a person or an animal.
The reporting requirement applies to all foods and animal feed regulated by the FDA, except infant formula and dietary supplements, which are covered by other regulatory requirements. Some examples of reasons a food may be reportable include bacterial contamination, allergen mislabeling or elevated levels of certain chemical components.
The opening of the RFR electronic portal reflects a fundamental principle of the President’s Food Safety Working Group that “preventing harm to consumers is our first priority.”
“President Obama has pledged to strengthen food safety,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “The opening of the Reportable Food Registry electronic portal represents a significant step toward that pledge.”
“By fostering real-time submission to the FDA of information on food safety hazards, the registry enhances FDA’s ability to act quickly to prevent foodborne illness,” said Michael R. Taylor, senior advisor to the commissioner. “Working with the food industry, we can swiftly remove contaminated products from commerce and keep them out of consumers’ hands.”
The requirements apply to any person who has to submit registration information to the FDA for a food facility that manufactures, processes, packs, or holds food for human or animal consumption in the United States. These people are termed responsible parties.
A responsible party:
Must investigate the cause of the adulteration if the adulteration of food may have originated with the responsible party
Must submit initial information; followed by supplemental reports
Must work with the FDA authorities to follow up as needed
A responsible party is not required to report if it found the problem before the food was shipped, and corrected the problem or destroyed the food.
The agency issued draft guidance on the RFR in June and sought comment. The FDA also held three public workshops across the country in which FDA representatives explained the RFR requirements and how the portal will work. A Federal Register notice was issued today announcing the opening of the RFR electronic portal and the availability of final guidance to assist the food industry in complying with the requirements of the RFR.
Stephanie Kwisnek, 301-827-0955 Consumer Inquiries:
The U.S. Food and Drug Administration (FDA) today issued the results of its interim safety and risk assessment of melamine and melamine-related compounds in food, including infant formula.
A safety/risk assessment is a scientifically based methodology used to estimate the risk to human health from exposure to specified compounds. It is based on available data and certain scientific assumptions in the absence of data. The purpose of the FDA interim safety/risk assessment was to identify the level of melamine and melamine-related compounds in food which would not raise public health concerns. The interim safety/risk assessment evaluated the melamine exposure in infant formula and in other foods.
The safety/risk assessment, prompted by reports of melamine contamination of milk-derived ingredients and finished food products containing milk manufactured in China, was conducted by scientists from FDA’s Center for Food Safety and Applied Nutrition and the Center for Veterinary Medicine. The FDA reviewed scientific literature on melamine toxicity. The FDA is in the process of identifying a group of experts that would be charged with the task of reviewing the risk assessment and providing guidance regarding the current gaps in scientific knowledge relating to the toxicity of melamine and its analogues.
FDA is currently unable to establish any level of melamine and melamine-related compounds in infant formula that does not raise public health concerns. In large part, this is because of gaps in our scientific knowledge about the toxicity of melamine and its analogues in infants, including:
the consequences of the continuous use of infant formulas as the sole source of nutrition;
the uncertainties associated with the possible presence and co-ingestion of more than one melamine analogue; and
for premature infants with immature kidney function, the possibility that they may be fed these formulas as the sole source of nutrition and thus on a body weight basis experience greater levels of intake for a longer time than is experienced by term infants.
There is too much uncertainty to set a level in infant formula and rule out any public health concern. However, it is important to understand that this does not mean that any exposure to any detectable level of melamine and melamine–related compounds in formula will result in harm to infants.
Other Food Products
In food products other than infant formula, the FDA concludes that levels of melamine and melamine-related compounds below 2.5 parts per million (ppm) do not raise concerns.
This conclusion assumes a worst case exposure scenario in which 50% of the diet is contaminated at this level, and applies a 10-fold safety factor to the Tolerable Daily Intake (TDI) to account for any uncertainties. The TDI is an estimate of the maximum amount of an agent to which an individual could be exposed on a daily basis over the course of a lifetime without an appreciable health risk.
FDA continues to screen products, collaborate with foreign governments and their regulatory agencies, and monitor reports of contamination from international sources to help ensure that potentially contaminated products from foreign sources are examined if imported into the United States. If products are adulterated because they contain melamine and/or a melamine-related compound, the agency will take appropriate actions to prevent the products from entering commerce.