Florida Audiologists Asked to Comment to FDA on PSAP Verses Hearing Aid Regulations April 21st

Legislative Update
Submitted by Barry Freeman, Ph.D., VP of Professional Affairs

The Food and Drug Administration (FDA) has reopened its comment period regarding the Agency’s 2013 draft PSAP Guidance document, and the Agency has also requested comment on the availability, accessibility, and use of hearing aids and PSAPs for consumers with hearing loss. FDA is also seeking input on the October Report by the President’s Council of Advisors on Science and Technology (PCAST) which recommended that FDA create a “basic” category of hearing aids for over-the-counter (OTC) sale.

As part of this effort, FDA is conducting a workshop on April 21 on “Streamlining Regulations for Good Manufacturing Practices (GMPs) for Hearing Aids” which will examine various topics of hearing aid affordability and accessibility. HIA will fully participate in the Workshop and ongoing review processes which FDA has outlined, and will stress the importance of focusing on best outcomes for people with hearing loss as well as careful analysis of deregulated hearing aid markets worldwide as outlined.

FCC wants to increase Hearing Aid Compatibility (HAC) requirements for cellular handsets. The new rule, endorsed by telecommunications and consumer associations including HLAA, would require providers to increase their percentage of HAC handsets to 66% in two years; 85% in five years; and to move towards 100% HAC compliance in eight years, pending further study of feasibility and technological developments. The FCC rule, when finalized, would also establish that nearly all handsets that are used to make calls when held up to the ear meet HAC standards.

Senators Rob Portman (R-OH) and Kristin Gillibrand (D-NY) introduced S. 2424, the Early Hearing Detection and Intervention Act of 2015 (EHDI) on December 18 to reauthorize and update the program which promotes hearing screenings and follow-up for children who are born deaf or hard-of-hearing. The program was enacted in 2000 when only about 40% of newborns in the U.S. were screened at birth. Now, 97% of infants are screened thanks in part to the provision of EHDI grants. Professional Audiology organizations worked with Congressional hearing champions to pass EHDI in the House of Representatives in September 2015, and will support efforts to pass S. 2424.

• – A Pharma startup, Decibel Therapeutics is working on drug candidates to improve the effectiveness of cochlear implants and other hearing loss therapeutics.
• – Consumer Electronics Association (CEA) has dropped ‘Electronics’ from its name and is now the Consumer Technology Association (CTA). CEA/CTA endorses the marketing of PSAPs to treat hearing loss.
• – FDA approves an at-home hearing test. Click here for more information.

New Jersey reintroduces hearing aid tax credit bill, A 1108, that would provide $1,000 per hearing aid for people who make less than $150,000 per year.