High Costs, Lack of Medicare Coverage Contribute to Underuse of Hearing Aids
To address the problem of underutilization of hearing aids among hearing impaired individuals in the United States, the FDA has announced that it will be hosting a public workshop to outline the agency’s perspective on the current good manufacturing practices (GMPs) for hearing aids and to gather stakeholder input about improving its regulatory practices.
Between 25% and 40% of the American population aged 65 years and older suffer from age-related hearing loss (ARHL), making it the third most prevalent chronic condition in older Americans. According to the National Institute on Deafness and Other Communication Disorders (NIDCD), only 30% of adults aged 70 years and older and 16% of adults aged 20 to 69 years who could benefit from wearing hearing aids have ever worn them.
This underutilization is most likely due to the high cost of hearing aids, especially high-quality digital hearing aids. Recently, a report from the President’s Council of Advisors in Science and Technology recommended that modifications to the FDA’s regulation of hearing aids could “enhance the pace of innovation” and lead to a “decrease in cost and improvement in capability, convenience and use of assistive hearing devices.” William Maisel, MD, MPH, acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, explained, “Additional insight from all stakeholders will help us to better understand how we can overcome the barriers to access and spur the development of devices that compensate for impaired hearing.”
The workshop, “Streamlining Good Manufacturing Practices (GMPs) for Hearing Aids,” will be held on April 21, 2016, at the FDA’s headquarters in Silver Spring, Maryland.
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