Over-the-Counter (OTC) Hearing Aids
This timeline is based on current intel and subject to change.
On October 19, the U.S. Food and Drug Administration proposed rules for OTC hearing aids. This started a 90-day public comment period to ensure all voices are heard and lawmakers get these rules right.
A hearing aid is not a consumer electronics device; they are medical devices and should be regulated as such.
These rules are designed with the purpose to provide greater access to hearing assistance for those with perceived mild-to-moderate hearing loss. However, without proper guardrails in place to protect patient’s long-term hearing health, these products could result in more harm than help.
The public comment period is now closed for further consideration before the final regulations are announced.
We hope the FDA will Listen Carefully and put patient safety first.
These devices are a new category of hearing aids that consumers will be able to buy directly, without visiting a hearing health professional. They are intended to help adults who believe they have mild-to-moderate hearing loss, at budget friendly prices. However, lower prices often result in lower quality of care.
Hearing loss is unique to each individual, which is why it’s important that licensed, trained hearing health professionals continue to play a key role in a patient’s hearing loss journey.
It is critical OTC hearing aids are properly regulated and labeled to protect Americans’ long-term hearing health.
65% [of hearing aid owners] would definitely purchase a hearing aid through a hearing care professional even if an OTC option were available.
States Where AGs Are Taking Action
In the absence of proper regulations, companies are currently marketing unregulated, low-quality amplification devices as hearing aids. This has prompted more than 17 states’ attorneys general (AGs) – both Democrats and Republicans – to warn consumers about these harmful products.
Note: Green states are where AGs are taking action.