The Over-the-Counter Hearing Aid Act of 2017 will not fix a broken hearing care system without innovations and new delivery models.

SAN LEANDRO, Calif., June 5, 2017 -- iHEAR Medical supports the Over-the-Counter (OTC) Hearing Aid Act of 2017, which was recently introduced in Congress to improve access and affordability of hearing aids. About 86% of Americans with hearing loss, over 30 million people, go untreated, making hearing impairment the most common form of disability. The consequences of untreated hearing loss include lower income, reduced access to healthcare and education, and higher incidence of depression and social isolation. Recent reports have highlighted how hearing aid use can be a life changing experience for many.

Provisions of the OTC Hearing Aid Act of 2017 are based on recommendations from the President's Council of Advisors on Science and Technology (PCAST) and the National Academies of Science, Engineering, and Medicine (NAS).  "The OTC Hearing Aid Act is consistent with measures iHEAR has been calling for to lower the cost and remove barriers for millions currently denied access to quality hearing care. The bill also creates a new framework for technological innovation and new business models," stated Adnan Shennib, Founder & CEO of iHEAR Medical.

iHEAR is pioneering cloud-based hearing solutions to deliver high quality hearing aids directly to consumers at a fraction of the cost of conventional programmable hearing aids, which cost $2,400 per device on average.  With programmable digital hearing aids offered at $299 per device, iHEAR brings the cost of advanced hearing aids in line with prescription eyeglasses.

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Changing Global Demographics and Socioeconomics

The World Health Organization (WHO) estimates 5% of the world's population, or approximately 360 million people, suffer from a disabling level of hearing loss. While 95% of those with hearing loss can be readily treated with a hearing aid, less than 10% of them use one.  Hearing loss has become increasingly prevalent in the US, and is now the third most common health problem after heart disease and arthritis. With the average cost of hearing aids reaching $5,000 for a pair, only 14% of Americans with hearing loss currently own a hearing aid due to excessive cost and limited access to hearing care.

Disparity in Hearing Healthcare is Widespread

Hearing aids, including premium models, cost no more than $100 to manufacture. However, consumers are expected to pay a ten to twenty-fold markup for a programmable hearing aid.  To capture more of the profits, the leading manufacturers have taken control of hearing aid distribution, acquiring hearing aid centers, retail chains, and audiology networks. With increased ownership and control over the distribution, the industry maintains a high-price, low-volume business model in which the overwhelming majority of those in need are left without a hearing solution.

The skyrocketing cost of quality hearing aids has widened the disparity in hearing health, with the affluent enjoying the benefits of customized hearing aids, while the majority continue to suffer the devastating effects of disabling hearing impairment. The disparity in hearing care particularly hits rural areas and inner cities, where populations have less income and reduced access to qualified hearing care.

Fixing a Broken Hearing Health System Requires more than New Regulations

The OTC Hearing Aid Act intends to remove layers of regulatory barriers preventing consumers from accessing quality hearing health care. The OTC Hearing Aid Act confirms the FDA's authority to supersede state laws that are confusing and in conflict with existing FDA regulations.  However, new regulations will not fix the broken hearing health system without innovations that empower consumers and deliver effective direct-to-consumer hearing solutions.  These innovations include accurate home hearing screening, self-fitting tools, and telemedicine to connect hearing professionals to consumers in communities with limited access to clinical settings.

New models for delivering hearing products and services are also needed to create a new value proposition based on low-price, high quality hearing care. iHEAR Medical intends to leverage its proprietary online platform to introduce innovative direct-to-consumer distribution models including through drug stores and retail chains.  The new OTC regulations in conjunction with innovative technology and alternative distribution models will disrupt the current ineffective paradigm of high-price, low-volume hearing care. This disruption is necessary to serve the millions currently deprived of affordable hearing solutions, as well as the rapidly approaching silver tsunami of baby boomers.

About iHEAR Medical

iHEAR Medical is a venture-backed firm dedicated to addressing the global need for affordable and accessible hearing solutions. iHEAR's products and business models break through persisting barriers preventing people with hearing loss from acquiring and using hearing aids, including high cost, complex dispensing procedures, and the stigma of traditional hearing aids worn visibly behind the ear.  iHEAR is pioneering cloud-based direct-to-consumer hearing solutions with 48 U.S. and international patents issued and pending in its intellectual property portfolio.

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