Tag Archives: hearing loss

FDA proposes rule to make many hearing aids cheaper

(Reuters) – The U.S. Food and Drug Administration on Tuesday proposed creation of a new category of over-the-counter (OTC) hearing aids to be sold directly to millions of Americans in an effort to make the devices more affordable.

White House spokeswoman Jen Psaki said the proposed rules should be finalized next year and should increase competition to drive down prices, so the devices cost “hundreds instead of thousands of dollars.”

The changes “will help millions of Americans with mild to moderate healing loss get access to cheaper and more convenient access to hearing aids,” she told reporters, adding just one-fifth of the estimated 37.5 million Americans who have trouble hearing use such aids.

The rule allows greater reach to communities of color that have been typically lacked access to hearing aids, said Xavier Becerra, secretary of Health and Human Services.

Under the proposal, hearing aids for severe hearing loss or for users younger than 18 would remain as prescription devices.

The department will take comments on the proposed rule for 90 days and plan to implement the rule 60 days after finalizing it.

“Finalizing this remains a top priority for the agency,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said during a press call.

Representative Debbie Dingell called the announcement “a major step forward for hearing health and will increase the accessibility of affordable hearing aid options for those who need them.”

The proposed rule follows an instruction in President Joe Biden’s broad competition executive order, which had told the Department of Health and Human Services to “promote the wide availability of low-cost hearing aids,” among many other instructions aimed at a wide variety of industries.

(Reporting by Manojna Maddipatla in Bengaluru and Diane Bartz and Trevor Hunnicutt in Washington; Editing by Shinjini Ganguli and Nick Zieminski)

U.S. warns citizens in China after ‘abnormal’ sound injures consulate worker

U.S. Secretary of State Mike Pompeo gestures as he testifies at a hearing of the U.S. House Foreign Affairs Committee on Capitol Hill in Washington, U.S., May 23, 2018. REUTERS/Leah Millis

By Michael Martina

BEIJING (Reuters) – An American citizen working at the U.S. consulate in the southern Chinese city of Guangzhou has reported suffering from “abnormal” sounds and pressure leading to a mild brain injury, the U.S. embassy said on Wednesday.

The embassy, which issued a health alert to Americans living in China, said it could not link the case to health issues suffered by U.S. government staff in Cuba dating back to late 2016.

However, later on Wednesday, U.S. Secretary of State Mike Pompeo told lawmakers that the “sonic attack” in China was “medically similar” to the incidents in Cuba.

The unnamed American citizen assigned to the consulate in Guangzhou had reported a variety of “physical symptoms” dating from late 2017 to April this year, the U.S. embassy in Beijing said in an email.

The worker was sent to the United States for further evaluation. “The clinical findings of this evaluation matched mild traumatic brain injury (MTBI),” the embassy said.

The State Department was taking the incident very seriously and working to determine the cause and impact, the embassy said. Pompeo said that medical teams were heading to Guangzhou to investigate the incident.

The State Department added the Chinese government told the embassy it is also investigating and taking appropriate measures.

“We cannot at this time connect it with what happened in Havana, but we are investigating all possibilities,” a U.S. embassy official told Reuters.

China’s Foreign Ministry did not immediately respond to a request for comment.

The U.S. government on Wednesday issued a health alert to Americans in China, warning them about the incident it described as “subtle and vague, but abnormal, sensations of sound and pressure”.

“While in China, if you experience any unusual acute auditory or sensory phenomena accompanied by unusual sounds or piercing noises, do not attempt to locate their source. Instead, move to a location where the sounds are not present,” the emailed alert said.

The U.S. government in October expelled 15 Cuban diplomats from the United States for what it said was Cuba’s failure to protect staff at the U.S. embassy in Havana from mysterious health incidents at one point thought to possibly have been acoustic “attacks”.

Staff there reported symptoms including hearing loss, dizziness, fatigue and cognitive issues, though Cuban officials dismissed the idea of acoustic strikes as “science fiction” and accused Washington of slander.

The cause of those incidents remains unresolved.

The Canadian government in April said it would remove families of diplomats posted to Cuba after Canadian personnel there in 2017 also reported similar health symptoms.

(Reporting by Michael Martina; Additional reporting by Lesley Wroughton and Patricia Zengerle in Washington; Editing by Darren Schuettler and Susan Thomas)

Zika virus findings show hearing loss to some babies

An Aedes aegypti mosquito is seen inside a test tube as part of a research on preventing the spread of the Zika virus and other mosquito-borne diseases at a control and prevention center in Guadalupe,

CHICAGO (Reuters) – A study in Brazil of 70 babies whose mothers had confirmed Zika infections found that nearly 6 percent had hearing loss, adding a new complication to the list of ills the virus can cause when women are infected during pregnancy.

The Brazilian study, published on Tuesday in the U.S. Centers for Disease Control and Prevention’s weekly report on death and disease, confirmed less rigorous reports of deafness among infants born to mothers with Zika infections.

The finding is part of an effort to fully characterize the harm caused by the Zika virus during pregnancy. The virus is best known for causing the severe birth defect microcephaly, characterized by undersized heads and underdeveloped brains. But other studies have shown that Zika can cause other brain abnormalities, vision problems and joint deformities.

In the latest study, a team led by Dr. Marli Tenório and Dr. Ernesto Marques of the Oswaldo Cruz Foundation in Pernambuco, Brazil, examined records from 70 infants with microcephaly whose mothers had laboratory-confirmed Zika infections during pregnancy.

They found that nearly 6 percent had hearing loss without any other plausible cause.

Several other viral infections during pregnancy can cause hearing loss, including rubella and cytomegalovirus, or CMV, infections. The current study adds Zika infection to that list.

Scientists say Zika should now be considered a risk factor for hearing loss, and children who were exposed during pregnancy but have normal hearing at birth should be screened regularly for delayed or progressive hearing loss.

The connection between Zika and microcephaly first came to light last fall in Brazil, which has since confirmed more than 1,800 cases of microcephaly.

(Reporting by Julie Steenhuysen; Editing by Jonathan Oatis)