There are many options available for improving hearing ability. Some of these options are hearing aids that will be prescribed by a licensed hearing care professional; other options include over-the-counter (OTC) hearing devices. OTC devices may look like a hearing aid and may be marketed like a hearing aid, but the description will refer to an OTC device as an "assistive device" or "personal amplifier." When the price of an OTC instrument can range from only $50 to several hundred dollars each, it's understandable that many people may want to "test drive" OTC devices before trying an appropriately-prescribed hearing aid.
Some OTC devices even fit the FDA definition of a "hearing aid" (FDA, 2007a, S874.3300), yet their distribution often does not meet FDA requirements. The FDA requires a individual buying a hearing aid to be examined by a physician to rule out medical contraindications or the individual must sign a medical waiver if he or she chooses not to obtain medical clearance. Most OTC devices are purchased in a retail store or over the internet; in this situation the consumer never interacts with an audiologist or physician and may never be asked for proof of medical clearance. Researchers Calaway and Punch (2008) found that only one OTC manufacturer, of those investigated, required consumers to sign a medical waiver prior to purchase. The authors concluded that some of these OTC products were being sold outside of FDA regulations.
In this same research study the authors investigated the quality of amplification provided by OTC hearing aids. The authors found that the lowest cost OTC products provided poor amplification, but as the cost of OTC products increased, the quality of the amplification increased. In all cases the OTC devices were not being prescribed by a licensed professional. As an audiologist, this concerns me for several reasons. Anyone considering the purchase of a hearing aid should undergo a diagnostic evaluation to determine type and degree of hearing loss and to evaluate whether medical intervention is warranted. The recommendation for amplification should be provided by a qualified professional based on that evaluation. The hearing care professional can fit the device(s) according to each patient's hearing loss and can work with the patient to ensure success with the device(s).
Finding a qualified professional is the first and most important step in getting hearing help. It's important that hearing-impaired consumers seek out qualified professionals when receiving hearing care. For people with hearing impairment, experience with OTC devices may not be representative of an experience with a well-prescribed hearing aid. By asking friends and family, as well as other medical professionals, such as your primary care physician, it should be an easy task to find a knowledgeable hearing care professional that serve as your guide to better hearing.
Callaway, S.L., and Punch, J.L. (2008). An Electroacoustic Analysis of Over-the-Counter Hearing Aids. American Journal of Audiology, 17,14-24.
U.S. Food and Drug Administration, (2007a). Subpart D - prosthetic devices. Retrieved May 6, 2007, from www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch. 21:22.214.171.124.23.4.