Hearing Health and Technology -- Workshop, Project No. P171200 #00115

Submission Number:
Jacqueline Price
Initiative Name:
Hearing Health and Technology -- Workshop, Project No. P171200
OTC hearing aids can be an option for mild losses only when an Audiologist is involved. Hearing aids should be prescribed by an Audiologist who will make sure that the problem is actually an aidable problem and not some other medical issue such as wax impaction, APD, middle ear abnormalities etc. The Audiologist is the gatekeeper to making sure the consumer is choosing a device that is appropriate for that patient based off of needs, hearing loss, and budget. Without the professional involvement one runs the risk of being an unsuccessful hearing aid wearer. How can an Audiologist do their job if we are not the first face the hearing impaired see? There is a reason the profession of Audiology exists. OTC hearing aids misses the point. Hearing Healthcare is about the person, not just a widget. If the goal is to help consumers then only providing a widget without professional support will lead to failure and negligence on the part of the government who allowed the OTC Act to be implemented without professional intervention. We live in a society where if it doesn't seem normal then we don't like it and we will not use it. This mentality is why hearing aids can and have ended up in a drawer defeating the purpose of helping the consumer. By adding in the Audiologist the consumer has a resource, a counselor and a professional working with them to ensure success. Success with needs assessments, evaluations and validation using REM of the appropriate device. Senator Warren and Senator Grassly are only looking at a widget. The FDA needs to step up and mandate the professional component to hearing aid purchasing. Recognize that hearing loss is more complex than a widget and an evaluation from an Audiologist is providing the consumer with an ethical first point, gold standard of care. Once evaluated the consumer then can make a choice. A choice to buy a PSAP or a choice to go with a hearing aid. To make a choice without a diagnostic test to determine the degree and cause of the hearing loss is unethical and negligent. The FDA will be the leader in that unless they can mandate the evaluation as first point of contact and then the consumer can choose what route of rehabilitation that best suits their needs. Buying a hearing aid without an Audiologist involved will create more confusion and more people not be getting the help they need. Healthcare is NOT a one size fit all method. Hearing loss should not be a one size fit all OTC treatment. If the FDA is going to do this, then do it right. Mandate that the Audiologist be the first contact for an evaluation before purchase of the OTC device.