Maine Medicine Weekly Update
October 31, 2021

In This Issue
One Step Closer to COVID Vaccines for Kids; FDA Authorizes Vaccine for Children Ages 5-11
Identifying Child Maltreatment
Identify to Protect: Recognizing the Signs of Child Maltreatment
More COVID Guidance & News
US FDA & CDC Officially Expand Eligibility Recommendations For COVID-19 Booster Shots
Moderna COVID-19 Vaccine Booster Dose Webinar & Ordering Reminders
Further Clarification to The Moderna Guidance That Was Previously Sent to Providers
Upcoming Training Sessions for Pfizer COVID-19 Vaccines
New Standing Orders for Moderna, Janssen, & Pfizer with Booster Language Dose Information
Immunocompromised Americans who had a 3rd COVID-19 shot can now get a 4th
COVID-19 Monoclonal Antibody Therapies in Maine
US CDC Adds Certain Mental Health Conditions to List of High-Risk Individuals Eligible for Booster Shots
US Surgeon General Vivek Murthy on Vaccinating Kids, Mix and Match Boosters, Other Top Concerns
US Supreme Court Lets Maine Health Care Vaccine Mandate Stand
JAMA, NEJM Studies, Reports & Helpful Information
Top JAMA, JAMA Network, and New England Journal of Medicine Articles
Maine Track Teaching Opportunities
Teaching Opportunities in Tufts Medical School 'Maine Track'
FDA Rules Notices
FDA Moves to Allow Over-The-Counter Hearing Aids
Fraud Alert
Scammers Target Medical Conferences
Whaaaaatt ... ???
Surgeons in Egypt Remove Phone That Man Swallowed & Waited Six Months For It To ‘Pass Naturally’
Registration is Open! November 5th Governor's Office Opioid Response Seminar Series
Upcoming Specialty Society Meetings
Join us for an introduction to hospice services in our webinar on November 2nd: Let’s Talk Hospice!
AAP EQIPP Course: Immunizations - Strategies for Success (for RURAL Health Providers)
SUPPORT For ME Training and Technical Assistance Initiative Webinars on November 3 & December 1
Maine Independent Clinical Information Service: MICIS presentations & Academic Detailing
Physician (BC/BE in Family Medicine) - Mt. Abram Regional Health Center, (Kingfield, Maine)
Physician (BC/BE in Family Medicine) - Bingham Area Health Center

Search Back Issues




Follow Us:
FDA Rules Notices

FDA Moves to Allow Over-The-Counter Hearing Aids

The Food and Drug Administration (FDA) is moving toward making hearing aids available without a prescription to those with mild or moderate hearing loss.

The goal is to boost accessibility and lower costs for the devices Hearing aids can cost thousands of dollars ($5,000 on average) and aren't usually covered by traditional Medicare or private insurance, and advocates argue that making them available over the counter can drastically lower the price.

The FDA’s proposed regulation implements the Over-the-Counter Hearing Aid Act, which was signed into law in 2017. The FDA is expecting opposition from hearing aid manufacturers and audiologist groups.

FDA statement announcing the rule

  • Approximately 15% of American adults (37.5 million) age 18 and over report some trouble hearing.
  • Only about one-fifth of people who could benefit from a hearing aid use one.
  • Hearing aids would be sold over the counter in more traditional brick-and-mortar retail stores or online (rather than doctors’ offices or specialty retail outlets).
  • The new over-the-counter category would apply to certain air-conduction hearing aids intended for adults aged 18 and older who have perceived mild to moderate hearing loss.
  • Hearing aids for severe hearing loss or for users younger than age 18 would be prescription devices.
  • The FDA also issued an updated draft guidance, Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products (PSAPs).

Interested parties can submit either electronic or written comments on the proposed rule by January 18, 2022. Submit written comments (including recommendations) on the collection of information under the Paperwork Reduction Act of 1995 by November 19, 2021.

< Previous Article | Next Article >

[ return to top ]

To ensure delivery of Maine Medicine Weekly Update,
please add 'info@mainemed.com' to your email address book or Safe Sender List.
If you are still having problems receiving our communications,
see our white-listing page for more details: http://www.commpartners.com/website/white-listing.htm

Unsubscribe here

For more information or to contact us directly, please visit www.mainemed.com | ©