Health
Children with total deafness regain hearing after ‘groundbreaking’ gene therapy: ‘Like a miracle’
Five children who were born completely deaf have had some reversal of hearing loss after receiving a “groundbreaking” gene therapy.
The clinical trial, which was co-led by Mass Eye and Ear in Boston and the Eye & ENT Hospital of Fudan University in Shanghai, was the first in the world to apply gene therapy to children in both ears, according to the researchers.
The research has just been published in Nature Medicine on June 5.
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In addition to regaining their hearing, the children participating in the trial — who ranged in age from 1 to 11 years old — were also able to identify the origins and locations of sounds, even in noisy environments, researchers said.
This was a follow-up to an earlier trial that began in Dec. 2022, in which the research team successfully performed the gene therapy in just one ear. This new study showed that treating both ears led to even greater benefits.
Five children who were born completely deaf have had their hearing loss reversed after receiving a “groundbreaking” gene therapy. (Eye & ENT Hospital of Fudan University)
All the children in the study had a hereditary form of deafness called DFNB9, which is caused by mutations in the OTOF gene.
The condition occurs when the OTOF gene is unable to produce a protein called otoferlin, which is essential for transmitting sound signals from the ear to the brain.
As a result, the children could not hear or speak.
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“The children were chosen because they would benefit most from early intervention of gene therapy, especially in speech acquisition,” study author Zheng-Yi Chen, DPhil, an associate scientist in the Eaton-Peabody Laboratories at Mass Eye and Ear in Boston, told Fox News Digital in an interview.
“From a safety standpoint, however, it is more risky for children.”
How the procedure works
During the “minimally invasive” surgical procedure, the doctors administered an injection of the human OTOF gene into the children’s inner ears.
The children remained in the hospital for around seven to 10 days for observation.
“After four weeks, the kids showed hearing perception in tests, and then gradually they gained the ability to speak,” Chen said.
Dr. Yilai Shu is shown communicating with a young patient at the Eye & ENT Hospital of Fudan University. (Eye & ENT Hospital of Fudan University)
Within the families, response to sound was noticed within two to three weeks.
“All five patients have restoration of hearing, speech perception improvements, and sound source perception in noisy environments,” Chen said.
The participants experienced only low-grade adverse effects, such as fever and vomiting.
“This is the first time in history that hearing loss is being reversed by gene therapy.”
“There were no serious adverse effects,” he said. “They all recovered without any intervention.”
The gene therapy is intended to be a one-time treatment and will not need to be repeated, the researchers said, although the children will likely require speech therapy.
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Until now, there has not been any single treatment for hearing loss, other than cochlear implants, according to researcher Yilai Shu M.D., PhD, director of the Diagnosis and Treatment Center of Genetic Hearing Loss at Fudan Hospital in Shanghai.
“This is the first time in history that hearing loss is being reversed by gene therapy,” Shu told Fox News Digital. “And, of course, we believe this will have a profound impact on children’s lives.”
Dr. Yilai Shu’s team is pictured working in the lab of the Eye & ENT Hospital of Fudan University. (Eye & ENT Hospital of Fudan University)
Chang Yiyi, a mother in Shanghai whose 3-year-old son, Zhu Yangyang, participated in the trial, spoke to Fox News Digital about the experience.
“When Zhu couldn’t speak at 2 years old and didn’t have a response to sound, we realized there was a problem,” she said.
After hearing tests, it was determined that Yiyi’s son had total deafness.
“It was unbelievable — the best feeling. It was like a miracle.”
“He would get very frustrated because he couldn’t understand, couldn’t speak, couldn’t hear,” she said.
Twenty-three days after receiving the gene therapy, the boy first responded to someone calling out to him.
“It was unbelievable — the best feeling,” Yiyi told Fox News Digital. “It was like a miracle.”
“Now he can say ‘Mommy’ and ‘I want’ and some simple sentences.”
Dr. Yilai Shu (center) is pictured in the operating room at the Eye & ENT Hospital of Fudan University. (Eye & ENT Hospital of Fudan University)
Approximately 430 million people worldwide have disabling hearing loss, including 34 million children, according to the World Health Organization.
More than 50% of hearing loss cases are the result of genetics.
Gene therapy is promising but limitations exist, expert says
Dr. Amy Sarow, the Michigan-based lead audiologist at Soundly, a hearing health care marketplace, noted that gene therapy has had some success in the treatment of cancer and eye disease, along with other emerging areas.
“It is exciting to think about how gene therapy could impact millions of individuals with hearing loss worldwide,” Sarow, who was not involved in the experimental gene therapy, told Fox News Digital.
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“However, it is essential to emphasize that there are many causes of hearing loss, and one type of gene therapy will not be right for every type.”
Even among genetic causes of deafness, different genes may cause abnormalities or dysfunction that affect different auditory pathways, according to Sarow.
“Thus, development of specific treatment interventions is dependent on causality and will still take time to develop.”
Dr. Yilai Shu examines a young patient at the Eye & ENT Hospital of Fudan University. (Eye & ENT Hospital of Fudan University)
Additionally, Sarow noted, a “reversal” of hearing loss does not mean that an individual will have normal hearing ability fully restored.
“The first three years of life are very important to language acquisition, and although these children would be behind their normal-hearing peers (having spent the first few years of life profoundly deaf), they would still have the possibility to ‘catch up’ to some degree,” she said.
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“Research tells us that the younger the intervention, the better for potential language development.”
As with any intervention, there can be risks with gene therapy. “One potential risk is that treatment may not be successful in every case,” Sarow said.
“Another potential risk is that the targeted gene therapy may not work in the targeted region.”
What’s next?
The next step is to follow the trial patients for a longer time period to ensure that the positive results are stable, Shu said.
Until now, there has not been any single treatment for hearing loss, other than cochlear implants, according to one of the researchers. (iStock)
Based on the results of the first study, the researchers expect that the patients’ hearing abilities will continue to improve over time.
“Then we want to expand to older patients, and gauge how the treatment works for aging adults,” he said.
“Ultimately, we want the patient to have a choice about which treatment option they want to go with.”
The researchers also plan to start the process of seeking FDA approval to bring the gene therapy to the U.S.
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“We are working to bring this to people outside China, including the U.S., as quickly as possible,” Shu Fox News Digital.
The researchers also hope to extend this type of gene therapy to treat other types of deafness in the future.
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In a dramatic turn of events that’s captured the attention of animal lovers worldwide, Punch — the young macaque at a zoo in Japan famous for his inseparable bond with a stuffed orangutan toy — has reached a major milestone in his journey toward social integration.
On Thursday, visitors and staff at the Ichikawa Zoological and Botanical Garden witnessed a breakthrough: Punch was seen cuddling with and hitching a ride on the back of a fellow macaque.
Punch’s story began with hardship. He was abandoned by his mother shortly after his birth in July 2025 — and to ensure his survival, zookeepers stepped in to hand-rear the primate.
On Jan. 19, 2026, the zoo officially began the process of reintegrating Punch into the “monkey mountain” enclosure.
The transition was initially fraught with tension.
Punch’s story began with hardship when he was abandoned by his mother shortly after he was born. To help him, zookeepers gave him a stuffed toy that he began dragging around everywhere he went. (David Mareuil/Anadolu via Getty Images)
As a hand-reared infant, Punch was bullied and ignored by the established group of monkeys.
He was often seen huddled alone with his orange plush companion while the rest of the troop interacted.
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In an official statement released Feb. 27, the Ichikawa Zoological and Botanical Garden detailed the meticulous care behind this process.
Previous viral videos showed Punch bullied by the rest of the troop, running to his plushy toy for comfort. (David Mareuil/Anadolu via Getty Images)
“From an animal welfare perspective, our primary goal is to reintegrate Punch with the troop,” the zoo said.
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The strategy involved nursing Punch within the enclosure, so the troop could recognize him as one of their own, and pairing him with a gentle young female macaque prior to his full release to build his confidence.
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The latest footage, captured by X user @tate_gf, suggested the zoo’s patience is paying off.
The video shows Punch seeking physical contact not from his toy, but from another monkey — eventually climbing onto its back for a vital social behavior for young macaques: the “piggyback ride.”
The zoo’s strategy appears to be paying off: Punch, shown at far left, was recently seen riding on the back of a fellow macaque. (David Mareuil/Anadolu via Getty Images)
While Punch still carries his stuffed toy for comfort during moments of perceived danger, the zoo remains optimistic about his progress.
The organization cited the successful 2009 case of Otome, another hand-reared macaque who eventually outgrew her stuffed toy, successfully integrated — and went on to raise four offspring of her own.
The zoo has had crowds coming to see Punch, with hundreds of people lining up to get inside to see the young star, according to reports.
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“I’m hoping Punch has a good life like everybody else does, and think he’s a cute little guy,” one person commented online.
“Such a precious baby,” another person wrote.
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This story discusses suicide. If you or someone you know is having thoughts of suicide, please contact the Suicide & Crisis Lifeline at 988 or 1-800-273-TALK (8255).
Artificial intelligence has been touted as a boon to healthcare, but a new study has revealed its potential shortcomings when it comes to giving medical advice.
In January, OpenAI launched ChatGPT Health, the medical-focused version of the popular chatbot tool.
The company introduced the tool as “a dedicated experience that securely brings your health information and ChatGPT’s intelligence together, to help you feel more informed, prepared and confident navigating your health.”
But researchers at the Icahn School of Medicine at Mount Sinai have found that the tool failed to recommend emergency care for a “significant number” of serious medical cases.
The study, published in the journal Nature Medicine on Feb. 23, aimed to explore how ChatGPT Health — which is reported to have about 40 million users daily — handles situations where people are asking whether to seek emergency care.
Artificial intelligence has been touted as a boon to healthcare, but a new study has revealed its potential shortcomings when it comes to giving medical advice. (iStock)
“Right now, no independent body evaluates these products before they reach the public,” lead author Ashwin Ramaswamy, M.D., instructor of urology at the Icahn School of Medicine at Mount Sinai in New York City, told Fox News Digital.
“We wouldn’t accept that for a medication or a medical device, and we shouldn’t accept it for a product that tens of millions of people are using to make health decisions.”
Emergency scenarios
The team created 60 clinical scenarios across 21 medical specialties, ranging from minor conditions to true medical emergencies.
Three independent physicians then assigned an appropriate level of urgency for each case, based on published clinical practice guidelines in 56 medical societies.
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The researchers conducted 960 interactions with ChatGPT Health to see how the tool responded, taking into account gender, race, barriers to care and “social dynamics.”
While “clear-cut emergencies” — such as stroke or severe allergy — were generally handled well, the researchers found that the tool “under-triaged” many urgent medical issues.
The team created 60 clinical scenarios across 21 medical specialties, ranging from minor conditions to true medical emergencies. (iStock)
For example, in one asthma scenario, the system acknowledged that the patient was showing early signs of respiratory failure — but still recommended waiting instead of seeking emergency care.
“ChatGPT Health performs well in medium-severity cases, but fails at both ends of the spectrum — the cases where getting it right matters most,” Ramaswamy told Fox News Digital. “It under-triaged over half of genuine emergencies and over-triaged roughly two-thirds of mild cases that clinical guidelines say should be managed at home.”
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Under-triage can be life-threatening, the doctor noted, while over-triage can overwhelm emergency departments and delay care for those in real need.
Researchers also identified inconsistencies in suicide risk alerts. In some cases, it directed users to the 988 Suicide and Crisis Lifeline in lower-risk scenarios, and in others, it failed to offer that recommendation even when a person discussed suicidal ideations.
“ChatGPT Health performs well in medium-severity cases, but fails at both ends of the spectrum.”
“The suicide guardrail failure was the most alarming,” study co-author Girish N. Nadkarni, M.D., chief AI officer of the Mount Sinai Health System, told Fox News Digital.
ChatGPT Health is designed to show a crisis intervention banner when someone describes thoughts of self-harm, the researcher noted.
OpenAI launched ChatGPT Health, the medical-focused version of the popular chatbot tool, in January 2026. (Gabby Jones/Bloomberg via Getty Images)
“We tested it with a 27-year-old patient who said he’d been thinking about taking a lot of pills,” Nadkarni said. “When he described his symptoms alone, the banner appeared 100% of the time. Then we added normal lab results — same patient, same words, same severity — and the banner vanished.”
“A safety feature that works perfectly in one context and completely fails in a nearly identical context … is a fundamental safety problem.”
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The researchers were also surprised by the social influence aspect.
“When a family member in the scenario said ‘it’s nothing serious’ — which happens all the time in real life — the system became nearly 12 times more likely to downplay the patient’s symptoms,” Nadkarni said. “Everyone has a spouse or parent who tells them they’re overreacting. The AI shouldn’t be agreeing with them during a potential emergency.”
Fox News Digital reached out to Open AI, creator of ChatGPT, requesting comment.
Physicians react
Dr. Marc Siegel, Fox News senior medical analyst, called the new study “important.”
“It underlines the principle that while large language models can triage clear-cut emergencies, they have much more trouble with nuanced situations,” Siegel, who was not involved in the study, told Fox News Digital.
ChatGPT and other LLMs can be helpful tools, a doctor said, but they “should not be used to give medical direction.” (iStock)
“This is where doctors and clinical judgment come in — knowing the nuances of a patient’s history and how they report symptoms and their approach to health.”
ChatGPT and other LLMs can be helpful tools, Siegel said, but they “should not be used to give medical direction.”
“Machine learning and continued input of data can help, but will never compensate for the essential problem – human judgment is needed to decide whether something is a true emergency or not.”
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Dr. Harvey Castro, an emergency physician and AI expert in Texas, echoed the importance of the study, calling it “exactly the kind of independent safety evaluation we need.”
“Innovation moves fast. Oversight has to move just as fast,” Castro, who also did not work on the study, told Fox News Digital. “In healthcare, the most dangerous mistakes happen at the extremes, when something looks mild but is actually catastrophic. That’s where clinical judgment matters most, and where AI must be stress-tested.”
Study limitations
The researchers acknowledged some potential limitations in the study design.
“We used physician-written clinical scenarios rather than real patient conversations, and we tested at a single point in time — these systems update frequently, so performance may change,” Ramaswamy told Fox News Digital.
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Additionally, most of the missed emergencies happened in situations where the danger depended on how the condition was changing over time. It’s not clear whether the same problem would happen with acute medical emergencies.
Because the system had to choose just one fixed urgency category, the test may not reflect the more nuanced advice it might give in a back-and-forth conversation, the researchers noted.
ChatGPT Health is designed to show a crisis intervention banner when someone describes thoughts of self-harm. (iStock)
Also, the study wasn’t large enough to confidently detect small differences in how recommendations might vary by race or gender.
“We need continuous auditing, not one-time studies,” Castro noted. “These systems update frequently, so evaluation must be ongoing.”
‘Don’t wait’
The researchers emphasized the importance of seeking immediate care for serious issues.
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“If something feels seriously wrong — chest pain, difficulty breathing, a severe allergic reaction, thoughts of self-harm — go to the emergency department or call 988,” Ramaswamy advised. “Don’t wait for an AI to tell you it’s OK.”
The researchers noted that they support the use of AI to improve healthcare access, and that they didn’t conduct the study to “tear down the technology.”
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“These tools can be genuinely useful for the right things — understanding a diagnosis you’ve already received, looking up what your medications do and their side effects, or getting answers to questions that didn’t get fully addressed in a short doctor’s visit,” Ramaswamy said.
“That’s a very different use case from deciding whether you need emergency care. Treat them as a complement to your doctor, not a replacement.”
“This study doesn’t mean we abandon AI in healthcare.”
Castro agreed that the benefits of AI health tools should be weighed against the risks.
“AI health tools can increase access, reduce unnecessary visits and empower patients with information,” he said. “They are not inherently unsafe, but they are not yet substitutes for clinical judgment.”
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“This study doesn’t mean we abandon AI in healthcare,” he went on. “It means we mature it. Independent testing and stronger guardrails will determine whether AI becomes a safety net or a liability.”
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