People with hearing loss could soon buy hearing aids without needing to have an exam, prescription or special fitting first.
Driving the news: In a move years in the making, the FDA on Tuesday issued a final rule allowing over-the-counter sales of hearing aids to adults with mild or moderate hearing loss. Kids and those with serious hearing loss will still need a prescription.
- They could become available as soon as October when the rule takes effect.
Who wins with this rule?
- Patients with hearing loss: This change officially creates a new category of hearing aid that's expected to reach a far broader audience who may have previously avoided hearing aids due to cost and stigma. It's also expected to shake up prices and spur innovation across the market.
- Consumer electronics manufacturers: This will allow more companies to move into a space now dominated by specialty companies like ReSound, Sonova and William Demant, wrote Cowen analyst Eric Assaraf.
- Biden and the Dems: We're not trying to be cynical. But along with the health care wins in the Inflation Reduction Act, the timing of this — five years after Congress gave its blessing to the idea and less than 90 days before the midterms — just so happens to work out great for vulnerable Democrats.
Who loses?
- Manufacturers/hearing care: As Republican Sen. Chuck Grassley said, this would "lower prices" for consumers and result in "more competition" — which could hurt the bottom line of incumbents. Early estimates say consumers who purchase hearing aids in this category could save $2,800 per pair.
- Patients with hearing loss: Industry groups, like the Hearing Industries Association, have backed this move with a caveat, arguing consumers who skip seeing a doctor for hearing trouble may not get timely diagnosis and treatment for more serious problems.
Listen in: Axios Today podcast host Niala Boodhoo and Axios' Tina Reed discuss OTC hearing aids.
