Now Hear This: FDA Receives Guidance on OTC Hearing Aids

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ASHA, others join forces to offer recommendations

Four professional hearing care organizations—including the American Speech and Hearing Association—ASHA—are working together to offer advice to the FDA in terms of optimizing OTC hearing aids.

Appropriate labeling, adequate consumer provisions, and other points are emphasized in last month’s letter from ASHA, the Academy of Doctors of Audiology (ADA), the American Academy of Audiology (AAA) and the International Hearing Society (IHS).

The paper includes five key recommendations to the FDA:

  • Establish product requirements appropriate for OTC hearing devices targeting mild‐to‐moderate hearing impairment.
  • Define concise, outside‐of‐the‐box labeling appropriate for OTC devices, with strong recommendations to consult with a hearing health care professional.
  • Define comprehensive, inside‐the‐box labeling appropriate for OTC medical devices.
  • Define the new OTC category so that it is easily understood by consumers and aligns with risk-class requirements for safety and effectiveness.
  • Ensure adequate provisions for consumer protection, in coordination with the Federal Trade Commission (FTC).
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Rob Senior
Rob Senior

Rob has 15 years of experience writing and editing for healthcare. He previously worked for ADVANCE from 2002 to 2012.

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