ARTICLE
16 October 2024

Earbuds As Hearing Aids

MC
Marks & Clerk

Contributor

Marks & Clerk is one of the UK’s foremost firms of Patent and Trade Mark Attorneys. Our attorneys and solicitors are wired directly into the UK’s leading business and innovation economies. Alongside this we have offices in 9 international locations covering the EU, Canada and Asia, meaning we offer clients the best possible service locally, nationally and internationally.
Apple's AirPods are now FDA-approved as hearing aids for mild to moderate hearing loss, offering an affordable alternative to traditional aids. Regulatory approval delayed market entry, highlighting challenges in medical device innovation.
United Kingdom Food, Drugs, Healthcare, Life Sciences

According to an article in the Guardian, Apple's Airpods (RTM) can be used as hearing aids. And not just as a gimmick, but clinically approved hearing aids with FDA approval! For those with mild to moderate hearing loss, a clinical grade hearing aid system can be acquired for the price of a pair of high-end ear buds, rather than potentially thousand's of pounds on a traditional hearing aid.

The technology is relatively simple. The health app runs a hearing test through the earbuds and generates an audiogram of your hearing defects. This is then used to program the ear buds to act as a hearing aid.

The interesting point is that the technology is anything but revolutionary and the issue has been regulatory approval, preventing Apple from entering the market for several years. Which goes to show that there are many barriers to entry for medical devices.

Marks & Clerk has a dedicated Medtech team that can help Innovators in the Medtech space navigate the various barriers to entry including IP issues.

Apple's new AirPods will make America hear again, but no thanks to the regulator

www.theguardian.com/...

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