August 9, 2022
An important message about “over the counter hearing aids”
Recent news broadcasts have featured stories about “hearing aids” that can be bought “over the counter”, or without a prescription, an exam or professional fitting. This has naturally generated many questions to those of us in the hearing healthcare field. What are the instruments in question? Are they actual hearing aids? Will they fit all hearing loss cases? Will they work for me?
The Food and Drug Administration (FDA) has regulated the dispensing of hearing aids, as they are dispensed in a health care setting and have been labeled a “device.” A device is a mechanical instrument that, in this case, is intended for use in mitigating or treating medical conditions. Regulations involve qualifications for dispensing professionals, as well as guidelines for sale, fitting and use. These regulations serve to protect the public and ensure quality health care practices and good outcomes.
Instruments known as Personal Sound Amplification Products (PSAPs) are not subject to FDA regulations of “devices” because they do not fit the definition. They are not intended to treat or mitigate disease, but rather are intended to amplify sounds for specific environments for non-impaired listeners. They are neither programmed nor fit by professionals in-person based on valid exams. No expert counseling is needed.
Proposed changes in law would allow OTC hearing aids to be obtained without a valid exam by a licensed professional and to be programmable by the consumer without regard to any evidence-based gain algorithms based on valid testing. The International Hearing Society (IHS) has opposed all sales of hearing aids direct to consumers for the above reasons. Additionally, the risks of unnecessary fittings, hearing damage from excessive sound levels, missed ear disease and lack of appropriate counseling for the consumer have made the proposed sale of OTC instruments a major cause for concern.
OTC hearing instruments via internet or mail would also violate the regulations set forth in your state regarding dispensing professionals, procedures and consumer protections.
The recent claims made by those producing OTC hearing instruments may be sufficient to categorize the products as “devices.” This further presents a problem, as the reclassification would make them subject to the very regulatory guidelines they avoid by presenting them direct to the consumer.
We take our responsibility to you and your ears seriously. We encourage you to ask us about what we do and why we do it. Our continued goal is to keep you on a clear path to good hearing and ear health.
Ron D’Angelo, AuD
And the staff of professionals at Clear Choice Hearing and Balance