audiology otc hearing aid bill support

ADA Supports OTC Hearing Aid Bill; AAA Applauds FDA Decision to Eliminate Waiver

In a move that perhaps caught some in the audiology community by surprise, the Academy of Doctors of Audiology (ADA) announced its support of S.9, the Over-the-Counter Hearing Aid Act of 2016. In a statement released by ADA, it said that the organization “commends Senators Warren and Grassley for their foresight in introducing and advancing…

Read More
fda hearing aid medical waiver eliminated

FDA Eliminates Hearing Aid Medical Clearance Regulation – Effective Immediately

WASHINGTON, D.C. — Today during the National Academies of Science, Engineering and Medicine Dissemination Meeting, Hearing Health Care for Adults: Priorities for Improving Access and Affordability, Eric Mann, Chief, Ear, Nose and Throat Devices Branch of the U.S. Food & Drug Administration (FDA) announced that it does not intend to enforce the requirement for adults…

Read More
hearing aid bill senate

BREAKING NEWS: US Senators Warren and Grassley to Introduce “Over-the-Counter Hearing Aid Act of 2016”

WASHINGTON, DC — Prominent US Senators, Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa), announced today that they will introduce the Over-the-Counter Hearing Aid Act of 2016 when the US Senate returns to session. Citing recommendations from the recent PCAST and NAS reports on hearing aid accessibility and affordability, the bipartisan legislation would make certain types of hearing aids available…

Read More
tinnitus drug pharma hearing loss

FDA Fast Tracks Tinnitus Drug; Meniere’s Drug Completes Year-Long Safety Trial

ZUG, SWITZERLAND — Biopharmaceutical company Auris Medical Holdings announced late last month that the US Food and Drug Administration (FDA) granted Fast Track designation to its investigational drug, KeyzilenTM (AM-101).  Keyzilen is esketamine gel for intratympanic injection, intended for acute peripheral tinnitus following cochlear injury or otitis media in adults.  The Fast Track designation by the FDA of an…

Read More
fda hearing aid meeting

FDA Will Convene April Hearing Aid Meeting

SILVER SPRINGS, MARYLAND — In a January 6th press release the US Food and Drug Administration (FDA) announced it will host a public workshop, “Streamlining Good Manufacturing Practices (GMPs) for Hearing Aids,” on April 21, 2016, at the FDA’s headquarters in Silver Spring, Maryland. The workshop will outline the agency’s perspective on the current GMPs…

Read More
https://www.whitehouse.gov/administration/eop/ostp/pcast

PCAST Issues Eye-Opening Report, HIA Strongly Opposes

On Friday, October 23rd the President’s Council of Advisors on Science and Technology (PCAST) released a report entitled, Aging America & Hearing Loss: Imperative of Improved Hearing Technologies. After several public meeting held over the past year, which were reported  previously by HHTM, PCAST members voted and approved the report. It will be published in the…

Read More

New MED-EL cochlear implant can be used with MRI, FDA finds

    DURHAM, NC–One drawback of wearing a cochlear implant (CI) is that it creates complications for CI wearers who need to undergo an MRI  (magnetic resonance imaging).  Doing an MRI scan of the head with the CI in place can prevent an accurate scan from being produced.  Worse yet, scanning any part of the body with…

Read More