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# FDA Mulling Different Regulatory Approaches for Hearing Aids
- URL: https://www.fdaweb.com/fda-mulling-different-regulatory-approaches-for-hearing-aids/
- Published: 2016-01-06T12:00:00.000Z
- Updated: 2026-09-15T02:25:41.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5134354

> Are there alternative FDA regulatory approaches that could accelerate hearing aid device innovation? Current hearing aids on the market are notorious under-performers, so innovation in the technology is what the agency wants to explore at a 4/21 [public workshop](http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm480239.htm?ref=fdaweb.com) on “Streamlining Good Manufacturing Practices (GMPs) for Hearing Aids.” During the meeting, FDA plans to outline its perspective on current GMPs that are required under the Quality Systems Regulation (QSR), while also receiving stakeholder and public input about alternative models that could speed newer devices to market while keeping quality design and manufacturing built into the process.  
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> According to the National Institute on Deafness and Other Communication Disorders, 37.5 million adults aged 18 and older in the U.S. report some form of hearing loss. However, only 30% of adults aged 70 and older and 16% of adults aged 20 to 69 who could benefit have ever used a hearing aid, no doubt due to the societal reputation for ineffectiveness the devices have earned.  
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> The agency notes that most hearing aids are regulated as Class I (low-risk) medical devices and are generally exempt from premarket review and clearance by the agency before marketing. FDA’s workshop addresses recommendations in a [report](https://www.whitehouse.gov/sites/default/files/microsites/ostp/PCAST/pcast%5Fhearing%5Ftech%5Fletterreport%5Ffinal.pdf?ref=fdaweb.com) from the President’s Council of Advisors in Science and Technology (PCAST) that recently recommended possible modifications to the agency’s regulation of the devices that could “enhance the pace of innovation” and lead to a “decrease in cost and improvement in capability, convenience and use of assistive hearing devices.”  
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> Additionally, FDA is reopening its comment period on a [draft guidance](http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm373461.htm?ref=fdaweb.com) that clarifies the difference in regulatory requirements between hearing aids and PSAPs—wearable electronic products for use by non-hearing impaired individuals to amplify sounds in certain environments. The draft states that hearing aids are medical devices subject to GMPs and other QSR requirements, but PSAPs are considered to be electronic products, as opposed to medical devices, and the guidance states that manufacturers should not use product labeling or promotional materials to suggest that hearing impaired consumers should use them. In reopening the guidance comments, the agency says it is “seeking feedback on the availability, accessibility and use of hearing aids and PSAPs for consumers with hearing impairment, particularly as it relates to issues and recommendations identified in the PCAST report.”