The FDA has classified Apple’s new “air-conducting hearing aid feature” for AirPods Pro as an over-the-counter (OTC) hearing aid software, allowing users to utilize their existing AirPods as a hearing aid for mild to moderate hearing loss without requiring a prescription, marking the first time a company has received authorization for such a feature through the De Novo pathway, which is used for novel medical devices with low to moderate risk and no direct precedent on the market; this classification signifies a significant step towards increased accessibility and affordability in hearing aid technology. The De Novo Number (DEN) is 2309, the Device Name is Hearing Aid Feature (HAF), the Classicification code is SCR as described here: Product Classification. At Accessdata, the very interesting FDA Decision Summary is DEN230081.pdf. Key points about the new FDA classification:
- Over-the-counter status:
The most significant aspect is that users can purchase and utilize the hearing aid feature on their AirPods Pro without a prescription from an audiologist, aligning with recent FDA regulations for OTC hearing aids.
- De Novo pathway:
Apple applied for this classification using the De Novo pathway, meaning the FDA reviewed the device as a novel product with no direct comparable on the market, allowing for a streamlined approval process.
Mild to moderate hearing loss:
The HAF is intended for individuals with perceived mild to moderate hearing loss, not severe hearing impairments.
- Software-based:
The “hearing aid feature” is actually a software update applied to existing AirPods Pro, not a new hardware device.
- Market disruption:
This HAF could significantly disrupt the traditional hearing aid market by offering a more accessible and potentially lower-cost option for consumers.
- Consumer protection concerns:
Some may raise concerns about the accuracy of self-fitting hearing aids compared to professionally fitted devices, particularly for individuals with more complex hearing needs.
- Liability issues:
Apple could face potential liability if users experience issues with the HAF, especially regarding the accuracy of sound amplification or potential harm from improper use.
Overall, the FDA’s classification of Apple’s hearing aid feature as an OTC software represents a notable development in the hearing aid market, potentially expanding access to hearing augmentation technology for a wider consumer base but does raise questions about potential limitations and consumer protection considerations.