Our mission, at Hear About Hearing (HAH) is to ensure that these new Over-The-Counter (OTC) hearing aids are safe, effective, and a good investment of your money.
The FDA has been mandated by Congress to create and regulate a new category of OTC hearing aids. They have been directed by Congress to treat these OTC hearing aids as medical devices, not consumer electronics, and to create regulations that protect consumers.
In the coming months, we anticipate that FDA will issue a proposed rule for the marketing and sale of OTC hearing aids. After the publication of the proposed rule, there will be a public comment period during which the general public can send their comments on the rules directly to the FDA.
This is an essential opportunity for anyone with an interest in responsible hearing care – including patients, caregivers, and consumer advocates – to send a message to FDA advocating for two important points that will make these devices safe and effective:
- Maximum output for OTC devices is limited to no more than 110dB SPL. This will ensure that the volume of the devices is not inadvertently increased to a dangerous level that induces pain or causes further loss of hearing.
- Maximum gain is limited to 25dB. This will ensure that the devices help the consumer hear clearly and effectively.
FDA regulation is an important step in ensuring more people have access to over-the-counter hearing aids. But the FDA has a responsibility to ensure the safety and effectiveness of these devices. You can help.
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