FDA Announcement Signals Deregulation of Hearing Aids, Eliminates Medical Evaluation Requirement The FDA issued new guidance that immediately removes a requirement for people 18 and older to receive a medical evaluation or sign a waiver before purchasing most hearing aids, and also opened the doors for the creation of a new over-the-counter category of hearing aids. Eric Mann, clinical deputy director ... News in Brief
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News in Brief  |   February 01, 2017
FDA Announcement Signals Deregulation of Hearing Aids, Eliminates Medical Evaluation Requirement
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Hearing Aids, Cochlear Implants & Assistive Technology / Regulatory, Legislative & Advocacy / News in Brief
News in Brief   |   February 01, 2017
FDA Announcement Signals Deregulation of Hearing Aids, Eliminates Medical Evaluation Requirement
The ASHA Leader, February 2017, Vol. 22, 12. doi:10.1044/leader.NIB5.22022017.12
The ASHA Leader, February 2017, Vol. 22, 12. doi:10.1044/leader.NIB5.22022017.12
The FDA issued new guidance that immediately removes a requirement for people 18 and older to receive a medical evaluation or sign a waiver before purchasing most hearing aids, and also opened the doors for the creation of a new over-the-counter category of hearing aids.
Eric Mann, clinical deputy director of the Division of Ophthalmic and Ear, Nose, and Throat Devices at the Food and Drug Administration (FDA), announced the new guidance at a Nov. 7 meeting on hearing health care in adults at the National Academies of Sciences (NAS) in Washington, D.C.
The regulatory agency stated its “commitment to consider creating a category of over-the-counter (OTC) hearing aids” that would not require the consultation of a licensed dispenser, a move the FDA says would increase the affordability and accessibility of hearing aids for consumers. The FDA will consider recommendations from previous reports by the NAS and from the President’s Council on Science and Technology, which support OTC hearing aids and regulatory changes.
“Hearing loss is a chronic health condition that affects many body and brain systems and whose treatment requires consideration of the whole person,” said Jaynee Handlesman, ASHA 2016 president, in a press release following the FDA announcement. “While ASHA strongly supports greater access to technology, a common misconception is that a hearing aid alone is enough to overcome a hearing disability. Treatment for hearing loss is more complex and requires a comprehensive assessment of a patient’s needs as well as professional counseling and aural rehabilitation provided by audiologists to ensure successful adaptation to hearing technology.”
ASHA has presented publicly to the FDA and has provided formal comments that oppose the OTC regulatory changes.
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February 2017
Volume 22, Issue 2