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Over-the-Counter (OTC) Hearing Aids

In October 2021, the U.S. Food and Drug Administration (FDA) 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. 


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.

On August 16, 2022, the FDA released its final OTC Hearing Aid Rule

We are currently in the process of reviewing the more than 200-page rule in its entirety and want to provide a brief update in the meantime. 

We are incredibly grateful to all of you who shared with the FDA that without proper guardrails in place to protect patients long-term hearing health, OTC products could result in more harm than help. 

We are encouraged that the FDA listened carefully and put in place an output limit of 111 decibels for OTC hearing products, instead of a 120-decibel output that was in their draft rule. This is a major step forward for patient safety.

Our position at Listen Carefully remains clear:

Hearing loss is unique to each individual, so it’s critical that licensed, trained hearing health professionals continue to play a key role in a patient’s hearing loss journey.    

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

As proper regulations are finalized and implemented, 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.

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