Over The Counter Hearing Aid Regulations
Jacksonville Speech & Hearing Center enthusiastically supports the concept of making hearing aids more accessible for those who need them. However, we want to ensure that regulations published by the Food and Drug Administration (FDA) governing the rollout of Over The Counter (OTC) hearing aids maximize patient safety and convenience.
The public comment stage for these regulations is now open and as a part of the hearing care community we must raise our voices regarding some of the regulations, or lack thereof. Together, we can ensure that over-the-counter hearing aids are safe and effective for all patients.
This is your chance to advocate for yourself and others in our community who deal with hearing loss. You will also be helping Jacksonville Speech & Hearing Center advocate for our providers who work hard every day to ensure our patients receive the best possible care.
We ask that you please take 5 minutes, personalize the message below as much as possible and submit. Your voice will play a vital role in shaping the direction of this new form of hearing healthcare.
Go to this site: http://www.hearabouthearing.org/act-now.html
Submit your message. You do this on by clicking the link above. You can use the one that is there or the one that we recommended below:
Subject: Changes Needed to Proposed FDA Regulations
Acting Commissioner Woodcock:
[Insert your personal tie, including your journey with hearing loss, your experience with hearing aids, and the audiology services you have received]
There are portions of the FDA’s proposed rule on OTC hearing aids that are unworkable and possibly even illegal. According to the current law, the regulations for OTC hearing aids are intended for consumers with mild-to-moderate hearing loss. The law says the FDA must provide reasonable assurances of safety and efficacy. The FDA’s proposed threshold of 115/120 dB output – as well as the lack of a proper gain limit – goes well beyond moderate hearing loss and has the potential to do serious additional damage to a patient’s hearing. I write to encourage the FDA to follow the law and adopt output and gain limits that conform to science- and evidence-based recommendations.
Additionally, there are no regulations regarding the locking of these devices. If manufacturers are given the freedom to lock their OTC hearing aids, patients with challenges will not have access to the healthcare professionals who can best assist them. It is the responsibility of the FDA to protect the patient by restricting the ability to lock OTC hearing aids.
More information regarding the proposed regulations can be found at: