OTC Hearing Aid Legislation Passes, FDA Expected to Develop Regulations Congress has passed legislation that requires the Food and Drug Administration (FDA) to develop regulations related to over-the-counter (OTC) hearing aids. At press time, President Trump was expected to sign the bill into law. (Check The ASHA Leader Blog for updates.) The new OTC provision is part of H.R. 2430, ... News in Brief
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News in Brief  |   September 01, 2017
OTC Hearing Aid Legislation Passes, FDA Expected to Develop Regulations
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Hearing Aids, Cochlear Implants & Assistive Technology / Regulatory, Legislative & Advocacy / News in Brief
News in Brief   |   September 01, 2017
OTC Hearing Aid Legislation Passes, FDA Expected to Develop Regulations
The ASHA Leader, September 2017, Vol. 22, 8. doi:10.1044/leader.NIB1.22092017.8
The ASHA Leader, September 2017, Vol. 22, 8. doi:10.1044/leader.NIB1.22092017.8
Congress has passed legislation that requires the Food and Drug Administration (FDA) to develop regulations related to over-the-counter (OTC) hearing aids. At press time, President Trump was expected to sign the bill into law. (Check The ASHA Leader Blog for updates.)
The new OTC provision is part of H.R. 2430, the Food and Drug Administration Reauthorization Act of 2017. The Senate version mirrors the OTC hearing aid provisions in the House bill and was considered “must-pass” legislation to avoid FDA shutdown for lack of funding. The bills require the FDA to develop regulations for the purchase of OTC hearing aids by adults with mild to moderate hearing loss.
While acknowledging that people with mild hearing loss may benefit from OTC devices, ASHA is particularly concerned about effects of OTC hearing aids on those with moderate hearing loss, and has advocated that those with moderate hearing loss seek the services of a licensed, certified audiologist. And although the legislation requires warning labels regarding use of OTC hearing aids by children, ASHA remains concerned about an absence of meaningful safeguards to ensure that these devices are not purchased or used by children.
ASHA also maintains that hearing loss is a medical condition, and that patients who side-step audiologist involvement in the evaluation, fitting and adjustment of hearing aids may grow frustrated managing the aids and either adjust them incorrectly or stop wearing them. Patients could possibly further damage their hearing via over-amplification.
ASHA has engaged both Congress and the FDA with these concerns. A recent Access Audiology article and ASHA webinar by audiologist Harvey Abrams address how audiologists can respond to emerging challenges and trends in audiology practice. A full analysis of the OTC legislation and its impact will appear in future issues of the Leader.
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September 2017
Volume 22, Issue 9