News and Events

BREAKING NEWS: US Senate Passes OTC Hearing Aid Legislation

WASHINGTON, DC — The US Senate passed the FDA Reauthorization Act today. The legislation, as reported previously, contains a provision that directs the FDA to develop a category of over-the-counter (OTC) hearing aids for adults with mild to moderate hearing loss. A House version of the bill was passed last month.

The OTC provision of the legislation would allow for hearing aids to be used “by adults to compensate for mild to moderate hearing impairment” to be sold over the counter. The bill also requests the FDA to issue regulations containing safety and labeling requirements for the new OTC category of hearing aids, as well as update its draft guidance on Personal Sound Amplification Products (PSAPs).

 

What’s Next for OTC Hearing Aids?

Following passage of the Over-the-Counter Hearing Aid Act by both the House and Senate, the bill will head to the president to be signed into law.

Once the bill is signed into law, the FDA will begin drafting rules and regulations for the new OTC category of hearing aids. The FDA has three years to complete the rules and regulations surrounding OTC devices, but advocates and organizations like HLAA are hopeful the process is completed much sooner.

Letter to Senator Elizabeth Warren

Senator Elizabeth Warren
317 Hart Senate Office Building
Washington, D.C.  20510
(202) 224-4543

Dear Senator Warren and Committee Members:

As a member of the Massachusetts Academy of Audiologists (MAA) I am writing to ask you reconsider your position on S.670, and its companion bill, H.R. 1652, the Over the Counter Hearing Aid Act of 2017.
Hearing loss is a complex problem that requires a multi-faceted and comprehensive solution.  Care provided by licensed Audiologists allows for:

  • Accurate diagnosis of degree and type of hearing loss. This diagnostic information is critical to determine the appropriate solution for the hearing loss.  Conditions such as conductive hearing loss, asymmetric sensorineural hearing loss, poor word recognition abilities, and severe-profound sensorineural hearing loss require medical intervention.  Accurate diagnostic assessment also allows for consideration of hearing technologies other than hearing aids, including cochlear implants and bone anchored hearing devices, which are more effective in treating the hearing losses in these groups of patients.
  • Accurate selection of hearing technology. There are many hearing technology options available and choosing the appropriate device is accomplished through dialog and expert guidance by a trained, licensed hearing professional.
  • Verification of device fitting. The fitting of hearing technology must be verified to ensure best outcomes and that no additional damage to the hearing mechanism may occur.  Audiologists have tools available to allow for verification of the hearing aid fitting and can modify the fitting based on these objective data.
  • Continued follow-up and support. Adaptation to a hearing device takes time as the brain learns to use the increased access to hearing that the technologies provide.  The Audiologist guides the patient through this process and is able to support optimized fitting and instruction during this period.

In a recent pilot study published in the Hearing Review (Tedeschi and Kihm, 2016), individuals supported by a hearing care professional through the testing, counseling, fitting and aftercare of the hearing solution had significantly better outcomes in daily use of device, addressed expectations, satisfaction, and willingness to recommend hearing devices.  Experienced Audiologists very frequently see patients who seek over-the-counter hearing devices for support and end up wasting additional funds, time and frustration on a poor solution and delay obtaining access to the appropriate support through hearing professionals.

Insurance coverage could also encourage greater patient use of amplification.  The state health insurance plan in Massachusetts (GIC) has up to a $1700 benefit.  In addition, Federal Blue Cross and Blue Shield has a $2500 hearing aid benefit.  Mandating that insurance companies provide coverage would greatly help with the outreach component and increase the penetration rate in the United States, instead of developing inferior products and decreasing patient satisfaction. 

A recent survey of our own membership revealed that 85% of the audiologists queried responded that they are not in favor of over-the-counter devices.  Massachusetts audiologists disagree with you, Senator Warren, and believe that an over-the-counter hearing aid option is not the solution to the access challenge.

The Massachusetts Academy of Audiology invites you to engage in a meaningful dialog surrounding the issue of access to hearing healthcare.  We look forward to your response to our request to work to find solutions that are not just accessed “a lot more cheaply” but support patient safety and efficacy of treatment.

Sincerely,

Adrienne Ulrich, Au.D. - Executive Director
Eva M. Bero, Au.D. - President

The Massachusetts Academy of Audiology
PO BOX 320649
Boston, MA  02132
www.audiology-mass.org

MAA Western MA Networking Event

New MAA and Liberty Mutual Discount…for Members Only!

MAA is pleased to announce that we have partnered with Liberty Mutual to offer our members a discount on their home and auto insurance!

A Message from Liberty Mutual:

As a member of the Massachusetts Academy of Audiology, you could save hundreds on your car and home insurance with Liberty Mutual*, while receiving advice and excellent service from licensed insurance counselors.  You will also have access to safety resources to help keep you and your family safe. (more…)