Dr. Mead Killion (left), and Dr. Stavros Basseas (center) are presented certificates of appreciation by section chair Ken Platz (right). Chicago AES Section, Sept. 12, 2018.
Eighty percent of Americans who could benefit from hearing aids either do not buy them or do not wear them; nearly 25 million people. 55% of those over 55 years old who went to an audiologist and were diagnosed with hearing loss did not purchase a hearing aid, predominantly because of the high cost. The burden of time to schedule an appointment with an audiologist, obtain an audiogram, get fit for a hearing aid, and subsequent follow up visits for tuning also present barriers to adoption.
In 2009 the FDA announced a non-regulated product category called Personal Sound Amplification Products (PSAPs). Like hearing aids, PSAPs can address hearing loss by providing additional amplification to the user. Unlike hearing aids, PSAPs are available over-the-counter (OTC) without a prescription, and do not require personalized fitting. In 2013 the FDA issued a requirement that PSAP not claim to address hearing loss. In the following years non-hearing health industry representatives (such as Etymotic Research), hearing loss advocacy groups, and academics petitioned the FDA to reverse this view, and it was signed into law in 2016. The reversal enabled low cost OTC products addressing hearing loss to come to market.
The Consumer Technology Association (CTA) developed a set of ANSI performance standards (members.cta.tech/ctaPublicationDetails/?id=47bbe855-3429-e811-bbd4-0003ff5278c6&reload=tim...) to allow PSAPs to meet a minimum standard for efficacy. This standard defines parameters such as bandwidth and maximum output (among other things). PSAPs meeting the CTA standards may include a logo on the product packaging (www.hearingreview.com/2017/06/consumer-technology-association-releases-new-logo-otc-hearin...) indicating compliance, which provides consumers with an indication of device effectiveness.
Well-designed PSAPs (meeting the CTA standards) can improve intelligibility as well as hearing aids. Academic research has shown that high quality PSAPs have better subjective fidelity than some hearing aids. Additionally, there has been no evidence of PSAPs worsening or hastening hearing loss compared to hearing aids.
Sound World Solutions (SWS) was founded in 2007 by Dr. Basseas to help people currently underserved by the existing hearing aid distribution system. The aim is low-margin devices using integrated off-the-shelf Bluetooth and DSP components to keep costs low. Screening and programming of the PSAPs is done via a smartphone app. This removes the need for isolation booths and other test equipment, which further reduces prices and increases accessibility. User response has been very positive so far, and formal research has found little difference in speech intelligibility between traditional hearing aids and SWS devices.
