SAN FRANCISCO--(BUSINESS WIRE)--Jun 11, 2025--
SoundHealth, a medical technology company harnessing the power of artificial intelligence and medical science to improve patient outcomes, announced it received United States Food and Drug Administration (FDA) approval for pediatric use of its groundbreaking SONU Band. SONU is the world’s first FDA De Novo authorized, AI-enabled, wearable medical device for at-home treatment of moderate to severe nasal congestion due to allergic and non-allergic rhinitis. This expanded approval makes SONU the first FDA-approved, drug-free solution for nasal congestion and allergies in children ages 12 and up, providing a safe alternative to pharmaceutical treatments.
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“SONU offers a promising new option for children struggling with chronic nasal congestion. As a non-invasive, drug-free solution, it addresses a significant need among families looking for safe, effective alternatives to traditional therapies—particularly those involving steroids or medications with side effects,” said Dr. Alan Greene, Adjunct Professor of Pediatrics, Stanford University; Principal Investigator.
Clinically proven to be fast-acting and effective, over 80 percent of SONU patients reported improvement in their nasal symptoms. SONU represents a brand-new category of safe and rapid relief therapies for nasal congestion and spares patients from the side effects commonly associated with other treatment options.
“Nasal congestion and allergies don’t have to be life-altering,” said Dr. Paramesh Gopi, founder and CEO of SoundHealth. “Our team of scientists, engineers and medical professionals has truly revolutionized respiratory health with AI-powered sound therapy. We are thrilled to now be able to offer relief from congestion to children and will continue to work toward helping people breathe better.”
SONU is easy, convenient and pleasant to use for patients. Using SoundHealth’s proprietary AI technology, the SONU app scans the patient's face using a smartphone and creates a digital map of their sinuses, calculating their optimal resonant frequencies. Following the initial one-time scan, the patient simply places the SONU Band around their head, turns it on and the band delivers frequencies tailored to the patient based on the app’s calculations.
The science behind SONU:
SONU is the only FDA-approved device equivalent to or better than the leading nasal steroid spray, calming down symptoms of allergies, inflammation and congestion. For more information, please visit https://soundhealth.life/.
About SoundHealth
SoundHealth is a medical technology company that harnesses the power of artificial intelligence and medical science to improve respiratory and mental health. The SoundHealth team consists of experienced medical professionals, data scientists and engineers who are passionate about improving healthcare. Visit https://soundhealth.life.
SoundHealth has developed the world’s first FDA-approved, wearable device for children 12 and up that offers a drug-free, safe solution for treating nasal congestion and allergies.
WASHINGTON (AP) — Venezuelan opposition leader María Corina Machado met with U.S. President Donald Trump, presenting him with her Nobel Peace Prize medal and praising his support for Venezuelan democracy, even as Trump has signaled a willingness to work with the country’s acting president.
As Machado was in Washington, acting President Delcy Rodríguez delivered her first state of the union address in Caracas, calling for reforms to Venezuela’s state-run oil industry aimed at attracting foreign investment following the removal of former President Nicolás Maduro. The former vice president also outlined a distinct vision for the future between the two historic adversaries, straying from her predecessors, who have long railed against American intervention in Venezuela.
This is a photo gallery curated by AP photo editors.
Military leaders arrive at the National Assembly where acting President Delcy Rodriguez addresses lawmakers in Caracas, Venezuela, Thursday, Jan. 15, 2026. (AP Photo/Ariana Cubillos)
National Assembly lawmaker Nicolas Maduro Guerra, son of deposed President Nicolas Maduro, and his wife Grysell Torres arrive at the National Assembly for Venezuela’s acting President Delcy Rodriguez first state of the union address in Caracas, Venezuela, Thursday, Jan. 15, 2026. (AP Photo/Ariana Cubillos)
Venezuela's acting President Delcy Rodriguez delivers her first state of the union address at the National Assembly in Caracas, Venezuela, Thursday, Jan. 15, 2026. (AP Photo/Ariana Cubillos)
Venezuela's acting President Delcy Rodriguez addresses lawmakers next to a picture of former President Nicolas Maduro and his wife Cilia Flores, at the National Assembly in Caracas, Venezuela, Thursday, Jan. 15, 2026. (AP Photo/Ariana Cubillos)
Venezuela's acting President Delcy Rodriguez arrives at the National Assembly in Caracas, Venezuela, Thursday, Jan. 15, 2026. (AP Photo/Ariana Cubillos)
Venezuela's acting President Delcy Rodriguez, center, National Assembly President Jorge Rodriguez, left, and Interior Minister Diosdado Cabello arrive at the National Assembly in Caracas, Venezuela, Thursday, Jan. 15, 2026. (AP Photo/Ariana Cubillos)
Venezuelan opposition leader María Corina Machado greets supporters on Pennsylvania Avenue near the White House after meeting with President Donald Trump Thursday, Jan. 15, 2026, in Washington. (AP Photo/Pablo Martinez Monsivais)
Venezuelan opposition leader Maria Corina Machado reaches out to embrace Sen. Ted Cruz, R-Texas, left, as the Nobel Peace Prize recipient meets with Sen. Alex Padilla, D-Calif., right, and others two weeks after President Donald Trump toppled Venezuelan president Nicolas Maduro in a stunning military raid, at the Capitol in Washington, Thursday, Jan. 15, 2026. (AP Photo/J. Scott Applewhite)
Venezuelan opposition leader María Corina Machado arrives at the Capitol, Thursday, Jan. 15, 2026, in Washington. (AP Photo/Allison Robbert)
Venezuelan opposition leader María Corina Machado, left, leaving the White House in Washington, after meeting with President Donald Trump Thursday, Jan. 15, 2026. (AP Photo/Pablo Martinez Monsivais)
Venezuelan opposition leader María Corina Machado, center, leaves the Capitol, Thursday, Jan. 15, 2026, in Washington. (AP Photo/Allison Robbert)
Venezuelan opposition leader Maria Corina Machado is welcomed as she arrives for meetings in the office of Sen. Dick Durbin, D-Ill., the ranking member of the Senate Judiciary Committee at the Capitol in Washington, Thursday, Jan. 15, 2026. (AP Photo/J. Scott Applewhite)
