Can Apple make hearing aids cool?

After dabbling in hearing health for years, Apple went all in this week with a battery of new updates, including software that will allow people to test their hearing with AirPods Pro and turn the wireless earbuds into hearing aids. Once it gets clearance from FDA, the features will be available to users with mild or moderate hearing loss.

In a new story, my colleague Timmy Broderick and I explore the big question: Will users take advantage of the feature to hear better? Millions of people have mild hearing loss that might make it hard for them to hear conversations in certain situations, such as a noisy restaurant, but never do anything about it. The recent availability of regulated over-the-counter products were supposed to make hearing amplification more accessible. But, experts told us that it hasn't really generated an explosion of interest.

The AirPods feature could add a virtually frictionless way for millions of existing users to be proactive about their hearing health. The widely accessible and familiar Apple products could help raise awareness and combat stigma. Still, hearing aids come with a learning curve. So people may not stick with Apple's new feature if they don't have expert help from an audiologist.

Another observation that warrants a mention is how social cues conveyed by AirPods might evolve over time if the feature catches on.

"For some people, seeing someone wearing AirPods may make them think the person is streaming music or podcasts and not paying attention to them, but over time this will change," said Catherine Palmer, director of audiology at University of Pittsburgh Medical Center. "Eventually, people may be comfortable knowing that the person is using the AirPods to hear them better, not block them out."

Read our whole story on Apple's hearing aids push here

Artificial Intelligence

FDA chief tells hospitals to 'step up' on AI regs

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Food and Drug Administration commissioner Robert Califf this week told a group of journalists, including STAT's Brittany Trang, that health systems need to take a leading role on regulating artificial intelligence in health care.

If they don't, he warned, the health systems might end up "holding the bag on liability" when algorithms don't work or cause harm. Califf explained that developers can't fully guarantee their algorithms because AI models' performance changes over time and may work differently in every patient population.

Califf's comments come amid a heated debate over how best to regulate artificial intelligence systems that are rapidly making their way into patient care. The commissioner mentioned the agency's efforts to support "self-assessment cooperatives," in which a network of labs would test algorithms. He also mentioned the necessity of hospitals taking steps to validate AI models for their own patient populations.

Digital health

MSK wars: Hinge, Sword updates

Companies offering virtual musculoskeletal care have become popular with employers who want to cut high costs for their workers' pain care that can include lots and lots of physical therapy sessions, expensive surgery, or dangerous drugs. Two top players, both valued in the billions, announced updates this week as competition heats up for new business.

Hinge Health this week announced an update to Enso, the FDA-cleared electric stimulation device it offers to users of its services. Ahead of the announcement, I caught up with CEO Daniel Perez who told me more than 100,000 members have used previous models. Perez also gave me an update on the company's business: "We actually generated cash in Q2, we're on pace to generate cash again in Q3, and we'll be consistently cash flow positive throughout 2025."
Not to be outdone, Sword Health, a competitor, this week announced it would guarantee results to clients with a new "Outcome Pricing" model in which "what clients pay will be directly determined by the effectiveness of Sword programs in helping improve the health of their people."

TELEHEALTH

Noom jumps into compounded weight-loss drugs

STAT's Katie Palmer tells us: Hims has already made it clear that it wants to continue selling compounded versions of blockbuster GLP-1 obesity drugs even after shortages of the FDA-approved meds from Novo Nordisk and Eli Lilly come to an end. Now, yet another large digital health company is jumping on the bandwagon: Noom, which offers weight loss coaching through an app, said it will offer compounded GLP-1s along with the branded drugs it already prescribed.

With the announcement, CEO Geoff Cook called on policymakers to continue to allow compounding of the drugs until Lilly and Novo lower their prices. Lucrative compounded GLP-1s have been a lifeline for direct-to-consumer telehealth companies struggling to make ends meet after the pandemic heyday; many companies have pivoted to include or even focus on the meds.

But the FDA's guidance is clear that lower prices alone aren't a valid reason to allow compounded copies of branded drugs. The big question is, as more digital health companies offer compounded GLP-1s, could they pressure regulators to let them keep the gravy train running.

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What we're reading

AI threatens to cement racial bias in clinical algorithms. Could it also chart a path forward?, STAT
For this South Dakota health system, leaning into telehealth means learning 'webside' manner, STAT
Hearing aid makers slip after Apple rolls out hearing aid features, analysts shrug off threat, Reuters
The regulatory status of health apps that employ gamification, Scientific Reports