We predict that the Personal Sound Amplifier category will drastically alter the audiology field in 2012. And here's why:
The image below shows the practically invisible RCA Symphonix model RPSA10, which is currently available right now as of the writing of this article, late December 2011, in 2,000 Radio Shack stores across America.
This new device, like many others which will start hitting retail outlets in the coming year, features everything that a mild- to moderate-hearing loss individual would want in a hearing aid, but without the prescription, or the required audiologist visit.
Moreover, the price point of these devices is coming in at around $179 to $300, a mere fraction of the thousands of dollars that hearing aid wearers are currently paying for their hearing augmentation devices.
Using a "one-size-fits-all" approach--like the Symphonix and the Walkers Digital HD, seen here on the left--these new devices are bringing the cost down, while providing a quick and convenient way for individuals to improve their hearing.
You can chalk up the huge price discrepancies to the rapidly decreasing prices for the cutting edge digital technology that's found in these Personal Sound Amplifier devices.
Devices like these aren't necessarily new. The Lee Majors Bionic hearing aid device have been marketed on television for a couple of years.
But a recent regulatory requirements by the U.S. Food and Drug Administration (FDA) to define hearing aids and this new class of hearing augmentation devices, which they are calling Personal Sound Amplifier Products, or PSAPs, has made it easier for consumer electronics manufacturers and marketers to bring this entirely new class of "hearing aids" to those needing mild to moderate hearing augmentation.
Here's an exceprt from "Guidance for Industry and FDA Staff: Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products, Feb. 25, 2009"
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. As such, there is no regulatory classification, product code, or definition for these products. Furthermore, there are no requirements for registration of manufacturers and listing of these products with FDA.
Many of these new PSAPs can be found right now on popular e-commerce sites, including the personal sound amplifiers which is found on Amazon.
Similar devices, such as the Panasonic JZ that we wrote about recently, are available only through select retailers or even require a hearing professional to see you first.
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