Can you explain what Personal Sound Amplifier Products (PSAPs) are, and who they are designed for?
Shawn: The category of Personal Sound Amplifier Products covers quite a broad range of devices. Generally speaking, if the product is several hundred dollars (as opposed to less than fifty dollars) you can expect a hearing device that provides many of the same technical features and similar performance to hearing aids that cost thousands of dollars. PSAPs are a consumer product, not a medical device, and therefore are typically sold through consumer retail channels. The FDA provides the following guidance on the distinction between hearing aids and PSAPs.
"Hearing aids and personal sound amplification products (PSAPS) can both improve our ability to hear sound," says Eric Mann, M.D., Ph.D, deputy director of FDA's Division of Ophthalmic, Neurological, And Ear, Nose, and Throat Devices. "They are both wearable, and some of their technology and function is similar."
Mann notes, however, that the products are different in that only hearing aids are intended to make up for impaired hearing. The distinction is primarily on the marketing claims that can be made. When marketing hearing aids, discussion of degree of hearing loss is appropriate and permitted. When marketing PSAPs, no mention of hearing loss can be made, as PSAPs are not classified as a medical device, and therefore are not considered appropriate to treat a medical condition such as hearing loss.
Hearing-aid users often complain that they cannot really hear well on the phone. Do PSAPs work well on the phone? If yes, what makes the difference?
Shawn: As a general rule, PSAPs will often have the same challenges and successes that hearing aids have. Those that offer Bluetooth technology (like our Sound World Solutions products) allow the user to connect the hearing device directly to the phone, permitting them to take and make calls where the audio is sent from the phone to the hearing device, resulting in a more direct and clear signal. Users can also take advantage of the Bluetooth link to stream audio podcasts or music directly from their phone to the hearing device.
Does the quality of the mobile phone used play a role in the quality of the user experience with a PSAP?
Shawn: Because our products interact with the phone through the Bluetooth link, the quality of the microphones or speakers in the phone does not have a direct impact on the user’s experience with our personal sound amplifiers.
What would you need or expect from the mobile phone manufacturers in order to mainstream PSAPs for people with hearing loss?
Shawn: The biggest challenge in getting more affordable hearing solutions, including PSAPs, into the mainstream is creating awareness in the minds of consumers that high quality, affordable hearing solutions are available. There are tens of millions of people in the U.S. and Europe (and many more in emerging markets) that would benefit from a solution that provides help with their hearing but have chosen not to acquire hearing aids from the traditional channel. Many of these consumers can be helped by the new technology solutions that are available. Mobile device manufacturers are in a unique position to communicate directly with their existing customers about the availability of these new solutions and the benefits provided.
In addition to PSAPs, are there other efforts underway to increase affordable hearing care options?
Shawn: There is currently much debate, particularly in the U.S., on how to make hearing care more affordable and accessible. The Institute of Medicine (IOM) earlier this year convened a committee on Affordable and Accessible Hearing, which sought input from a variety of sources and is expected to make recommendations in the next several months. The President’s Council of Advisors on Science and Technology (PCAST) also took up this issue recently, and is similarly expected to make their recommendations in the next several months. Industry watchers speculate that the recommendations will include changes to the FDA hearing aid regulations, greater consumer access to PSAPs and other hearables for the mild to moderately impaired and possible Medicare coverage of low cost hearing devices.
Learn more about Sound World Solutions: soundworldsolutions.com
Sound World Solutions has also developed the CS Customizer app, which allows users of Sound World Solutions' CS50/CS50+ Bluetooth Series personal sound amplifier, Companion, or Sidekick products to personalize their settings and control the device via Bluetooth link from their smartphone.
See the CS Customizer app on GARI: http://www.gari.info/findapps-detail.cfm?appid=261