In late summer 2022, the FDA announced something ear-resistible (so sorry, couldn’t help myself) that will have far-reaching implications for the multibillion-dollar hearing aid market. After years of bureaucracy and delays, the federal agency made it legal to sell hearing aids for mild to moderate hearing loss over the counter (OTC).

The FDA anticipates the ruling will usher in innovation and competition in the hearing aid tech market, which could become extremely profitable for the whole industry.

The OTC hearing aid industry was already valued at $1.05 billion in 2022, according to market research firm Grand View Research, even though the FDA ruling only went into effect in mid-October. The ruling could also be good business for audiologists, who have largely been in support of the OTC ruling.

Two products—one from California-based company Eargo and another from a collaboration between IT giant HP and Australian startup Nuheara—are the first commercially available OTC hearing aids. Differing in appearance, HP/Nuheara’s product was designed to look more like earbuds while Eargo’s is meant to be invisible.

The prices are also very different. HP/Nuheara’s OTC hearing aid, called the HP Hearing Pro, costs $699, and Eargo’s latest model (Eargo 7) comes in at $2,950.

Healthcare Brew sat down with leaders from both companies at CES 2023 to learn more about their products and what the new OTC ruling means for their businesses. Keep reading here.—MA

Do you work in healthcare or have information about the industry that we should know? Email Maia at [email protected]. For completely confidential conversations, ask Maia for her number on Signal.

It’s Amazon’s world. We just live in it.

The tech behemoth’s latest foray into the healthcare world is RxPass, a $5 monthly subscription for unlimited generic drugs. But analysts don’t think it will make a big splash in the pharmacy industry.

RxPass gives Amazon Prime members access to about 50 generic drugs delivered to their doorstep without insurance. Amazon touted RxPass for “making medications more accessible, affordable, and convenient” in its Jan. 24 announcement.

Analysts at investment banking advisory firm Evercore disagreed, though, and called the move “incremental.”

“Amazon has been attempting to gain a material presence in pharmacy retail for several years now, but its success has been relatively limited,” Mark Mahaney, a research analyst at Evercore, told Healthcare Brew. “We think the challenge here is mostly around changing consumer behavior.”

Nominal effect on the industry: Diving deeper into the generics world makes sense for Amazon, which already offers a Prime prescription savings benefit of about 78% for generics at 60,000 participating pharmacies. Plus, generic drugs make up roughly 86% of all US prescriptions. It’s also much harder for new companies to compete in the brand-name drug space because branded drugs cost substantially more and insurers already offer big discounts on those.

“The pharmacy experience has long needed transformation to better meet the needs of both patients and providers. RxPass is part of Amazon Pharmacy’s larger efforts to meet this need, bringing value, convenience, affordability, and price transparency in a vital part of healthcare that’s long lacked these features at scale,” Amazon Pharmacy Chief Medical Officer Vin Gupta told Healthcare Brew.

But Amazon is certainly not the only company to offer a competitively priced generic drug delivery service. Keep reading here.—MA

Ratios are back in the news—and no, not because celebrities are embarrassing themselves on social media. So-called safe staffing, a policy that sets ratios for the number of patients a nurse or other health provider can care for at one time, is gaining newfound attention in the wake of the Covid-19 pandemic.

A key factor in the recent New York City nurse strike, nurse-patient ratios are expected to remain a top issue as hospitals struggle to fill health worker shortages.

Unfamiliar with the concept or how we got here? Fear not, Healthcare Brew has got you covered.

State(s) of play: More than a dozen states have implemented hospital safe staffing standards—which often vary among facility units and/or license types—since California became the first state to adopt nurse-to-patient ratios in 1999. (They took effect in 2004.)

Most states require hospitals to have a committee of nurses and other staff that determine minimum care requirements for their facility, but some simply mandate disclosure of staffing levels, according to the American Nurses Association (ANA), a professional association that advocates for the committee approach. Other states require both approaches.

Today, California is still the only state to have set nurse-to-patient ratios in state law—although a Massachusetts law also sets ratios just for ICU patient assignments.

There are no federal standards, but advocates, like National Nurses United (NNU), are pushing for them.

Why it matters: Debate over hospital safe staffing has percolated in the US for years, sparking headlines amid high-profile ballot fights (think Massachusetts in 2018). But it’s escalated as more nurses leave the field, due in part to the pandemic. Many nurses who stay argue that they have fewer resources and must care for too many patients at once—even in places with safe staffing policies. Keep reading here.—SY

Do you work in healthcare or have information about the industry that we should know? Email Shannon at [email protected]. For completely confidential conversations, ask Shannon for her number on Signal.

Today’s top healthcare reads.

Stat: Individuals associated with now-unaccredited nursing programs peddled more than 7,600 fake nursing diplomas and certificates—and face up to 20 years in jail if convicted. (ABC News)

Quote: “You have to get used to hearing no.”—Thashana Jacobs, an outreach worker for an organization contracted by Starbucks to aid homeless people seeking shelter in the coffee shops (The Guardian)

Read: Pathologists specializing in pregnancy loss worry they’ll be asked to cooperate with police investigations in the Dobbs era. (Stat News)

Catch up on the top Healthcare Brew stories you may have missed:

• CES 2023 put digital health on full display
• Covid-19 pharma sales: Who came out on top?
• VC investment in healthcare set to cool down after record years