The U.S. Food and Drug Administration (FDA) will soon issue its final regulations governing the sale of over-the-counter (OTC) hearing aids. This will clear the way for consumers with mild-to-moderate hearing loss to access these devices without consulting a healthcare provider.
Family caregivers care for loved ones with a host of conditions, including chronic diseases, disabilities, and mental health issues – and hearing loss is no exception. Clear communication with family caregivers is essential to make sure that the needs of the patient are being met. Clear conversations can be challenging for those struggling with hearing loss. That’s why the availability of OTC hearing aids would be a welcome development not only for patients but for their family caregivers as well -- as long as those hearing aids are safe and effective.
We strongly encourage the FDA to ensure the safety of OTC hearing aids when issuing its Final Rule.
As it stands, the FDA’s proposed rules would allow for an upper sound output limit of 120 dB – equivalent to the volume of a chain saw – a level that has been deemed highly dangerous by the Centers for Disease Control and Prevention (CDC). This volume level could cause damage in as little as nine seconds. If the current output level is maintained and a gain level is omitted, hearing aids can be amplified to levels that are dangerous for those with mild-to-moderate hearing loss. This proposed output limit would also violate the authorizing statue.
The absence of a gain limit in the proposed rule is also extremely problematic. Gain refers to the amount of amplification applied to sound as it enters the hearing aid. In other words, a gain limit would ensure that hearing aids are not amplified to levels beyond those that are effective for individuals with moderate hearing loss. It would also ensure that hearing aid users do not overamplify the sound entering their ears. Without a gain limit, these devices would amplify sounds far beyond any recognized threshold of what is classified as moderate hearing loss. This is against the law and very dangerous.
As family caregivers, the safety of our loved ones will always be our primary concern. The objective must be to have hearing aids that are effective for those with mild-to-moderate hearing loss – enabling them to enjoy conversations and take part in normal social discourse – but without putting their hearing at even greater risk. At the very least the FDA should set a gain limit to comply with the statute – or, better yet, follow the recommendations of leading hearing aid professionals and lower the output limit to further ensure safety.
This is going to be a critical juncture for people with mild-to-moderate hearing loss and their family caregivers. It’s vital that the FDA get it right. The final rule that sets parameters for these devices should enable users to enjoy all of the benefits of hearing amplification without putting them at unreasonable risk for even greater hearing loss. The FDA must put safety above all else.