Personal Sound Amplification Products (PSAPs) are electronic devices that allow an individual to listen better in noisy environments, or for those situations when the signal is not strong enough for a listener, regardless of the reason. These products are not the same as hearing aids; the Food and Drug Administration (FDA) has issued a guidance document under the Food, Drug, and Cosmetic Act that outlines and identifies applicable legal requirements for hearing aids and for PSAP’s. As defined by these FDA Guidelines, “PSAPs are intended to amplify environmental sound for non-hearing-impaired consumers. They are not intended to compensate for hearing impairment. Examples of situations in which PSAPs typically are used include hunting (listening for prey), bird watching, listening to lectures with a distant speaker, and listening to soft sounds that would be difficult for normal hearing individuals to hear (e.g., distant conversations, performances). Because PSAPs are not intended to diagnose, treat, cure or mitigate disease and do not alter the structure or function of the body, they are not devices as defined in the Food, Drug and Cosmetic Act Guidelines.” (FDA, 2009)
The FDA defines the PSAP by “use,” from hearing aids in that:
“A hearing aid is a wearable sound-amplifying device that is intended to compensate for impaired hearing. A PSAP is a wearable electronic product that is not intended to compensate for impaired hearing, but rather is intended for non-hearing impaired consumers to amplify sounds in the environment for a number of reasons, such as for recreational activities. While some of the technology and function of hearing aids and PSAPs may be similar, the intended use (emphasis added) of each article determines whether it is a device or an electronic product. The intended use may be established by labeling materials. Promotional materials that make claims or suggest the use of a PSAP for hearing impaired consumers, such as in the description of the types and severity of hearing loss, establish an intended use that causes the product to be a device and therefore subject to the regulatory requirements for a hearing aid device, as described in this guidance.”
The FDA Guidelines further this differentiation by stating that while hearing aids and PSAPs both affect our ability to hear sound, the products have different intended uses, and are therefore subject to different regulatory controls.
The Lines Separating PSAPs and Hearing Aids are Becoming More Blurred
While initial (and many today) PSAPs were very basic sound amplifiers, the market is now seeing improvements in sound quality, cosmetics, functions, sound adaptive features and/or amplification, and noise cancellation. Essentially, many of the features of hearing aids are being incorporated into PSAPs to improve their performance and cosmetic appeal. So, from a functional point of view, the devices are becoming more similar. The primary differentiation relates to the conditions and definitions under which they can be sold. Essentially, the PSAP has to disassociate itself from the hearing aid attributed functions of compensating for reduction in measured hearing sensitivity.
Today there are hundreds of PSAPs in the market place and even a greater number of hearing aids. How does the consumer determine which is being sold? There are a number of things to look for:
- What is the product called? If described (called) a hearing aid, it is a hearing aid. If advertised as a PSAP, it is a PSAP
- Who is selling the product? If by an audiologist or hearing aid dispenser (hearing professional), it is most likely a hearing aid. If over-the-counter, Internet, or mail order, it is most likely a PSAP.
- Was a hearing test conducted? If so, the product being purchased is most likely a hearing aid. If not, or if asked to check listening experiences from a list, it is most likely a PSAP.
- Price. If the product has a cost from approximately $15 to $650 per unit, it is most likely a PSAP. If the cost ranges from approximately $1000 to $3000 per unit, it is most likely a hearing aid.
- Is the product defined to compensate for hearing loss? If so, it is a hearing aid. If the term hearing loss (or similar terminology related to loss of hearing) is avoided, the intent is to present the product as a PSAP.
Adding to the confusion is that the hearing aid and PSAP often look the same. Some PSAPs actually were hearing aids in their “previous” life, having lost their sales appeal, or reinvented to fit the sales requirement of a PSAP. In truth, any hearing aid could become a PSAP, but not all PSAPs would qualify to become quality hearing aids to be sold by the professional hearing community. Additional information about PSAPs can be found on the Hearing Health and Technology Matters Internet Blog Site hearinghealthmatters.org. Just type “PSAP” in the search box to access multiple posts about PSAPs.
Dr. Staab is an internationally recognized expert in the hearing health care discipline. He is President of Dr. Wayne J. Staab and Associates, a marketing, research, educational, publishing, manufacturing, and consulting organization, and also a founding partner/editor of Hearing Health and Technology Matters, an International blog site for hearing. Educated with a Master’s degree in Audiology and Doctoral degree in Hearing Science, he has held both academic and corporate positioned in the hearing industry. Dr. Staab specializes in hearing and hearing aid related issues, authoring numerous books, articles, and book chapters.
Guidance for industry and FDA staff. Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products, Document issued on: February 25, 2009, U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health, Ear, Nose, and Throat Devices Branch, Division of Ophthalmic, Neurological and Ear, Nose, and Throat Devices Office of Device Evaluation