PROPOSAL.
>> AND HEARING AIDS MAY SOON BE
AVAILABLE OVER-THE-COUNTER.
THE F.D.A. ISSUED A PROPOSAL TO
ALLOW HEARING AIDS TO BE SOLD
DIRECTLY TO CONSUMERS WITHOUT A
MEDICAL EXAM OR FITTING BY AN
AUDIOLOGIST.
AFTER CONGRESS PASSED
LEGISLATION IN 2017 REQUIRING
THE F.D.A. TO CREATE AN
OVER-THE-COUNTER CATEGORY.
THE AGENT SILL SAYS SOME 37
MILLION AMERICAN ADULTS HAVE
DIFFICULTY HEARING BUT ONLY ONE
IN FIVE PEOPLE WHO NEED HEARING
AIDS ACTUALLY HAVE THEM.
ONE BARRIER IS THE COST.
SOME SAY THIS LEGISLATION COULD
LOWER THAT FINANCIAL BURDEN.
JOINING US TO TALK ABOUT THE
PROPOSAL AND WHAT IT COULD MEAN
FOR PEOPLE WITH MILD TO MODERATE
HEARING LOSS ARE BARBARA KELLY
DIRECTOR OF THE HEARING LOSS
ASSOCIATION OF AMERICA A
CONSUMER GROUP WHICH HAS A
CHAPTER IN CHICAGO.
AND MIKE SHARP AN AUDIOLOGIST
AND THE VICE-PRESIDENT OF AD
LOGICAL AFFAIRS AT THE ILLINOIS
SPEECH LANGUAGE HEARING
ASSOCIATION.
THANK YOU FOR JOINING US.
FIRST, MIKE, IF YOU WOULD, PAIN
THE PROPOSAL AND WHAT IT COULD
MEAN FOR PEOPLE WITH HEARING
LOSS?
>> SO THE PROPOSAL IS CURRENTLY
FROM THE F.D.A. IN A 90-DAY
COMMENT PERIOD FOR ORGANIZATIONS
AND CONSUMERS TO COMMENT ON.
WE DON'T HAVE A DEADLINE AS FAR
AS WHEN THAT WILL BE OUT FOR
CONSUMERS BUT IT SHOULD CREATE A
CATEGORY OF HEARING DEVICES THAT
WILL BE AVAILABLE
OVER-THE-COUNTER FOR PATIENTS TO
ACCESS.
WHAT IS NICE ABOUT THAT, IS FOR
THE RIGHT CONSUMER THEY COULD BE
A VERY GOOD OPTION FOR SOMEONE
WHO MAYBE HAS PRICING ISSUES OR
HAS SOME SORT OF MAYBE DOESN'T
WANT TO ENTER THE HEARING AID
MARKET SO THERE'S LOTS OF
OPTIONS FOR PATIENTS.
AND HOPEFULLY WHAT IT WILL
CREATE.
>> AND BARBARA KELLY WHAT IS
YOUR REACTION TO THE PROPOSAL
FROM THE F.D.A. AFTER THE 2017
LEGISLATION THAT PUSHED FOR
OVER-THE-COUNTER HEARING AIDS.
>> WE HAVE BEEN WAITING FOR THE
PROPOSED RULE AND WE ARE EXCITED
ABOUT IT.
THESE ARE JUST FOR ADULTS WITH
MILD TO MODERATE HEARING LOSS
WHEN SOMEONE FINDS OUT THEY HAVE
A HEARING LOSS THEY WAIT 5-10
YEARS BEFORE THEY DO ANYTHING
ABOUT IT AND THAT IS TOO LONG TO
GO WITHOUT THE HUMAN CONNECTIONS
AND THERE'S CO-MORBIDITIES
ASSOCIATED WITH HEARING LOSS.
IF IT GETS THE PERSON TO TAKE
THE FIRST STEP SOONER WHEN
HEARING HEALTH IS APPEARS TO BE
MORE MAINSTREAM THAT SAY GOOD
THING.
>> AND BARBARA YOU MENTIONED
CO-MORBIDITIES WHAT ARE THOSE?
>> UNTREATED HEARING LOSS IS
ASSOCIATED WITH FALLS AND THAT
IS THE NUMBER ONE THING THAT
TAKES OLDER PEOPLE TO THE
EMERGENCY ROOM.
ISOLATION.
BECAUSE YOU'RE CUTOFF FROM HUMAN
CONNECTIONS AND IT'S TOO HARD TO
GO OUT IN GROUPS AND NOT BE ABLE
TO HEAR OR FAMILY GATHERINGS.
SO PEOPLE TEND TO ISOLATE WHICH
COULD LEAD TO ANXIETY AND
DEPRESSION, AND THERE'S RESEARCH
BEING DONE ON THE COGNITIVE LINK
BETWEEN UNTREATED HEARING LOSS
AND COGNITIVE DECLINE.
HEARING HEALTH IS VERY MUCH A
PART OF OVERALL HEALTH AS IS
EVERYTHING ELSE.
OUR BLOOD PRESSURE, CHOLESTEROL
LEVELS, EVERYTHING.
>> AND MIKE SHARP WHO ARE WE
TALKING ABOUT HERE?
THERE IS A MISCONCEPTION THAT
IT'S JUST OLDER ADULTS IMPACTED
BUT IT'S MORE PREVALENT?
>> MUCH MORE PREVALENT.
THERE IS A LOT MORE YOUNGER
ADULTS WHO MAY HAVE LONG-TERM
NOISE EXPOSURE BECAUSE OF THEIR
JOB OR SOME PEOPLE FOR GENETIC
FACTORS ARE MORE SUSCEPTIBLE TO
HEARING LOSS.
WE SEE PATIENTS ALL THE TIME
THAT ARE IN THEIR 40s AND
50s THAT MAY HAVE MILD HEARING
LOSS.
MAYBE THEY ARE NOT READY TO WANT
A TRADITIONAL HEARING AID AT
THAT POINT.
A COUPLE THINGS TO BE CAREFUL OF
THERE ARE HEARING LOSS CAUSED BY
MEDICAL CONDITIONS.
SO AN EVALUATION IS ALWAYS THE
MOST BENEFICIAL BUT IT'S ALWAYS
NOT THE MOST REALISTIC.
AND AN OVER-THE-COUNTER HEARING
TEST COULD BE BENEFICIAL FOR
PEOPLE MAYBE THEY DON'T FEEL
LIKE THEY HAVE THE PROBLEM THAT
WARRANTS A TRADITIONAL HEARING
AID.
>> HOW EXPENSIVE CAN HEARING
AIDS GET?
AND HOW MIGHT OVER-THE-COUNTER
AIDS MITIGATE THAT.
>> HERE HEARING AIDS RUNS THE
GAMUT THEIR TOP OF LINE WITH
ARTIFICIAL INTELLIGENCE THAT
MONITOR YOUR BLOOD PRESSURE AND
WHEN YOU FALL AND THEY CAN
RUNDOWN TO $2,000 A PAIR.
INSTEAD OF TALKING THOUSANDS, WE
WOULD BE TALKING HUNDREDS.
BUT THE IMPORTANT THING TO NOTE
IS WHEN YOU GET A HEARING AID
WITH AN AUDIOLOGIST OR
SPECIALIST YOU ARE PAYING FOR
THOSE SERVICES.
AND FOR SOME PEOPLE THAT IS VERY
IMPORTANT.
THE AFTER CARE, THE FOLLOW-UP.
THE FITTING THE ORAL
REHABILITATION.
WITH OVER-THE-COUNTER PRODUCTS
THESE ARE GOING TO BE TOTALLY
SELF FITTING WITHOUT THE HELP OF
A PROFESSIONAL.
SO WE'RE TALKING HUNDREDS AS
OPPOSED TO THOUSANDS.
AND SOME PEOPLE JUST NEED A
LITTLE HEARING ENHANCEMENT IN
THEIR 50s MIGHT BE IN THE
WORKPLACE, AGING INTO THEIR
HEARING LOSS OR HAD A LIFETIME
OF EXPOSURE MIGHT NEED HELP IN
THE CONFERENCE ROOM AT A TABLE
AROUND WITH THE MEETING.
SO THAT IS WHY THE OVER THE
COUNTER MARKET OPENS UP A LOT OF
POSSIBILITIES FOR PEOPLE.
>> AND MIKE, THERE ARE ALSO
DEVICES CALLED PERSONAL SOUND
AMPLICATION PRODUCTS THAT THE
ARE AVAILABLE ON THE MARKET.
WALK US THROUGH THE DIFFERENCE
BETWEEN THOSE AND WHAT COULD BE
THIS NEW CATEGORY OF HEARING
AIDS?
>> AMPLIFIERS ARE NOT REGULATED.
THEY ARE THE WILD, WILD WEST.
MOST OF THEM TEND TO BE
AMPLIFIERS THAT CAN TURN
EVERYTHING LOUDER AND SOFTER.
THE DOWNSIDE IS MOST HEARING
LOSS IS MORE COMPLEX.
MOST HEARING LOSS HAPPENS
BECAUSE OF AGING PEOPLE WILL
HAVE GOOD LOW PITCH HEARING AND
MORE HEARING LOSS IN THE HIGH
PITCH RANGE AND ISSUES WHERE I
CANNOT HEAR I HAVE TROUBLE
UNDERSTANDING WHAT YOU ARE
SAYING.
THE PROBLEM IS PERSONAL SOUND
AMPLIFIERS ONCE YOU TURN IT UP
LOUD ENOUGH YOU MAY BE OVER
AMPLIFYING AREAS OF THE HEARING
LOSS OR LACK THEREOF.
AN OTC WOULD BE EVEN THOUGH
THERE IS NO HEARING TEST FROM AN
AUDIOLOGIST OR SPECIALIST, YOU
WOULD BE TAKING A SORT OF
HEARING TEST USUALLY AN APP ON
THE PHONE.
WE DON'T HAVE ALL OF THE ANSWERS
YET.
>> AND IS SOUNDS LIKE WE'RE OUT
OF TIME IT SOUNDS LIKE THE OTC
HEARING AIDS WOULD BE MORE
SPECIFIC DEVICES COMPARED TO THE