by Amy Pajula, on August 5, 2023
When President Franklin D. Roosevelt signed the Social Security Bill into law on August 14th, 1935 he stated the 32-page Act was, "a cornerstone in a structure which is being built but is by no means complete". The Great Depression had overwhelmed traditional sources of aid for the jobless, aged, widowed, orphaned, and disabled, and economic security was needed.
The plan provided several provisions for general welfare and a social insurance program for retired workers. In 1954 amendments helped protect workers against income loss from disability by freezing their earnings and therefore ensuring extended periods of disability didn't wipe out their retirement earnings or survivor benefits. Over the years, the program expanded when in 1956, Congress established the Disability Insurance Program and for aged disabled Social Security recipients the Medicare program in 1965. The Medicare and Medicaid amendment resulted in one basic program for health insurance for those aged 65 and older (Medicare) and another health insurance for those with limited income (Medicaid).
Medicare's primary insurance benefit was hospital coverage automatically enrolling eligible beneficiaries in Part A. Part B was optional as a supplemental insurance that covered outpatient and physician services. Medicare Part C was enacted in 1997 as private insurance was evolving into a more managed-care approach.
Congress added prescription drug benefits (Part D) in 2003, and since then, benefits for wellness, prevention, and hospice care have been added. In 2022 Congress enacted the Inflation Reduction Act, which requires Medicare to negotiate prices for a limited number of brand-name drugs.
However, further attempts to expand Medicare to include dental, vision, and hearing care have not been successful. In fact, Medicare EXCLUDES hearing aid coverage. This means a recipient cannot make a case for coverage because there is an automatic exclusion.
In 1965 when Medicare was signed into law, it did not include coverage for hearing aids because hearing loss was seen as a normal part of aging and was not seen as a health problem or a disability.
Today, hearing loss is the third most prevalent health condition in older adults in the United States. Nearly 25% of those aged 65 to 74 and 50% percent of those who are 75 and older have disabling hearing loss.
The myriad of health, personal, and societal issues linked to untreated or undertreated hearing loss have been well documented. Hearing loss is estimated to account for 8% of dementia cases each year, and even a mild hearing loss triples your chance of falling. A large longitudinal study of claims data led by researchers at John Hopkins showed older adults with untreated hearing loss had an average of 46% more in total healthcare costs over ten years versus those without hearing loss. The study found untreated hearing loss to be associated with a greater risk of depression, dementia, heart attacks, and falls. In the Lancet Commission 2020 report on Dementia, Intervention, and Care, hearing loss was cited as the number one modifiable risk factor in mid-life (ages 45-65) that could be identified and treated.
In the meantime, implantable technology has evolved substantially. We now have a class III, FDA-approved, fully implanted (surgically) active middle ear device designed to replicate the ossicular chain using the natural vibration of the ear drum. Implantable hearing treatment improves everyday compliance and increases personal safety and security by allowing for 24-hour hearing in most situations, improving healthcare outcomes for individuals and society.
Class III Medical devices have a high bar when it comes to receiving FDA approval. They require Premarket Approval (PMA), an extensive scientific and regulatory review to evaluate their safety and effectiveness, and a lengthy and expensive clinical trial. When a device or drug receives FDA approval, it means after a thorough review, the FDA has decided the benefits outweigh the risks.
The Center for Medicare Services (CMS) has categorized the FDA-approved Class III active middle ear implant as a "hearing aid," and it is therefore excluded from coverage. In fact, CMS has continuously maneuvered and changed its interpretation of "hearing aid" to avoid covering more innovative hearing devices.
Unfortunately, this limits access for millions and stunts future innovation and advancement of hearing treatment options. For millions of people who have hearing loss, there is a significant unmet need to be able to hear all of the time.
