[hedora]

> In response to public comments and to assure the safety and effectiveness of OTC hearing aids, the final rule incorporates several changes from the proposed rule, including lowering the maximum sound output to reduce the risk to hearing from over-amplification of sound, revising the insertion depth limit in the ear canal, requiring that all OTC hearing aids have a user-adjustable volume control, and simplifying the phrasing throughout the required device labeling to ensure it is easily understood. The final rule also includes performance specifications and device design requirements specific to OTC hearing aids.

The previous version of this rule sounds pretty bad!

Imagine the OTC hearing aids all being instantly permanently deafening with no volume control, and, on top of that, they puncture your eardrum and only produce feedback whine!

[joshe]

Normal earphones don't have these restrictions. No one is making eardrum piercing earphones.

It would have been much better if they had just deregulated them right when congress told them to in 2017. Or even better the FDA could have allowed OTC 30 years ago.

Airpods are not regulated this way and they are much better engineered and more effective then even the best hearing aids.

We have squandered so many years of hearing for fantasy harms. For millions of people.

[wgm]

This is a pretty uninformed take. The tech in AirPods is great, but people using a normal earphone as a hearing aid will be disappointed. The vast majority of people with hearing loss have a degree of loss that varies by sound frequency. If you boost everything 40 dB so the high pitches are back to normal, the low pitches will be extremely uncomfortable. The programming of a hearing aid is in many ways more important than the "engineering" that makes an AirPod Pro a great listening device.

[rblatz]

That’s why apple supports importing an audiogram so you can selectively boost certain ranges of sound.

https://support.apple.com/en-nz/guide/iphone/iphb80ab7516/io...

[hedora]

Yeah. Also, I got a pair for my father in law (who has expensive hearing aids) for the remote listen accessibility feature (which uses the iPhone mic on the table next to the speaker instead of an in ear mic).

He was sorely disappointed. I tried that feature out before returning them, and agree.

[hedora]

Hearing aid manufacturers are currently making things loud enough to cause hearing loss in normal ears. According to the quote I pasted in, the comment period is the reason they are still prescription-only.

Also, the concerns about not having safe ear canal protrusion limits, and not having volume controls are not things I (or the regulators) invented.