- Written by Roseann Martoccia, Executive Director, LifePath
- Published: 29 September 2017
“OTC” bill proposed to improve access to affordable hearing aids
Millions of people in Massachusetts and across the country experience hearing loss as they get older, but they can't get the hearing aids they need because of high costs and complicated regulations. The bipartisan Over-the-Counter Hearing Aid Act, which Senator Elizabeth Warren has reintroduced with Senators Chuck Grassley (R-Iowa), Johnny Isakson (R-Ga.), and Maggie Hassan (D-NH), would make hearing aids less expensive and easier to access. A companion bill has been filed by Representative Joe Kennedy III in the House. The bill has received endorsement from organizations such as AARP, the Gerontological Society of America and the Hearing Loss Association of America.
The bill would make certain types of hearing aids available over the counter (OTC) to Americans with mild to moderate hearing impairment. It would also require the FDA to write regulations ensuring that this new category of OTC hearing aids meet the same high standards for safety, manufacturing protections and consumer labeling as all medical devices, which would provide consumers the option of an FDA regulated device at a lower cost.
Approximately 30 million Americans experience age-related hearing loss, including over half of adults between the ages of 70 to 79. However, only a small share of Americans with hearing loss (about 14%) use hearing aids, primarily due to the high cost. Hearing aids are not covered by Medicare or most private insurance plans. Out-of-pocket costs for one hearing aid can average $2,400, which is out of reach for many consumers. People with low or moderate incomes are less likely to have access to hearing aids compared to individuals with higher incomes.
Some of the key provisions of the Over the Counter Hearing Aid Act of 2017 include:
- Certain types of hearing aids designed to assist adults with perceived mild to moderate hearing impairment would be available over the counter.
- The requirement that consumers obtain a medical evaluation or sign a waiver of that examination in order to obtain an OTC hearing aid would be removed.
- The FDA would be required to issue regulations related to safety and labeling requirements for this new category of OTC hearing aids.
- The existing safety, labeling and manufacturing protections would be maintained and applied to OTC devices in order to ensure that OTC hearing aids would be held to the same high standards as other medical devices.
- The FDA would be required to update the existing draft guidance on Personal Sound Amplification Products (PSAPs), consumer electronics products that may use similar technology to hearing aids but are intended for use by individuals with normal hearing.