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Aging America & Hearing Loss:

Imperative of Improved Hearing

Technologies

October 2015

President’s Council of Advisors on Science and Technology

PCAST Hearing Study Scope

•Part of broader PCAST examination of aging

and technology

•PCAST recognized timely opportunity to support

older adults with mild to moderate hearing loss

•Children, adults with severe hearing loss, and

those with red flag conditions were outside the

scope of this study

President’s Council of Advisors on Science and Technology 2

PCAST Aging and Technology Study

Full Working Group

Christine Cassel,** National Quality Forum Ed Penhoet,** Alta Partners

President’s Council of Advisors on Science and Technology

**Denotes PCAST member

Rosina Bierbaum,** University of Michigan

Jo Ivey Boufford, New York Academy of Medicine

Sara Czaja, University of Miami

David Dring, Selfhelp

S. James Gates, Jr,** University of Maryland, College Park

Susan Graham,** University of California, Berkeley

Thomas Kamber, Older Adults Technology Services

Jason Karlawish, University of Pennsylvania

Art Kramer, University of Illinois

David Lindeman, CITRIS

Chad Mirkin,** Northwestern University

Craig Mundie,** Mundie & Associates

Beth Mynatt, Georgia Tech

William Press,** University of Texas at Austin

Maxine Savitz,** Honeywell (retired)

Charlotte Yeh, AARP

Working Group Members

Marjory Blumenthal, Executive Director, PCAST

Ashley Predith, Assistant Executive Director, PCAST Diane Pankevich, AAAS Fellow, PCAST

Jennifer Michael, Program Support Specialist, PCAST

Staff

Co-chairs

3

Science Writer

Robert Saunders, National Quality Forum

Urgent Need to Improve Hearing

President’s Council of Advisors on Science and Technology 4

Hearing Loss: Major Problem for

Older Adults

•Major health and social problem

–30 million have difficulty hearing now

–Hearing loss associated with social isolation, dementia, falls,

depression, and other conditions.

•Growing importance with aging population

–Nearly half of people over age 60 have hearing loss

–Number of older Americans will rise from 46 to 82 million

between 2014 and 2040

•Few adults with hearing loss use hearing aids

–Only ~15-30% of older adults with hearing loss use hearing aids

President’s Council of Advisors on Science and Technology 5

Cost Major Barrier to Use of Hearing

Technologies

•High cost (~$2400 per hearing aid)

•Most people pay out of pocket

–Medicare and many insurers do not cover it

•Innovation has not reduced cost

President’s Council of Advisors on Science and Technology

Other Barriers to Wider Use of

Hearing Technologies

•Difficult for consumers to shop for best value

–Challenges include bundling, complex state

regulations, and restrictions on online shopping

•Social stigma and limited consumer awareness

•Lack of engagement by health providers

President’s Council of Advisors on Science and Technology

PCAST Study Scope and

Conclusions

President’s Council of Advisors on Science and Technology 8

Problem Ripe for Change

•New technology advancing rapidly now

•PCAST believes a few key Federal actions now

could give momentum to needed changes

President’s Council of Advisors on Science and Technology 9

PCAST Conclusions

•Untreated hearing loss of tens of millions of

Americans is a greater challenge than small risk

of unusual medical conditions

•Now an opportunity to increase access to better,

cheaper technology for mild to moderate hearing

loss, like reading glasses

President’s Council of Advisors on Science and Technology

PCAST Study Recommendations

President’s Council of Advisors on Science and Technology 11

PCAST Goals for Recommendations

•Reduce cost to consumers

•Increase the number of people who use hearing

technology

•Stimulate innovation and technology

development

President’s Council of Advisors on Science and Technology

PCAST Recommendations

Open the Market

Recommendation 1. FDA should designate as a distinct category “basic” hearing

aids—non-surgical, air-conduction hearing aids intended to address normal, bilateral,

gradual onset, mild-to-moderate age-related hearing loss—and adopt distinct rules for

such devices.

i. FDA should approve this class of hearing aids for over-the-counter (OTC) sale,

without the requirement for consultation with a credentialed dispenser. FDA

should also approve for OTC sale, both in stores and on-line, tests appropriate to

the self-fitting and adjustment of these OTC devices by the end user. Such hearing

treatments and tests meet the FDA requirements for OTC products, which are that

consumers should be able to self-diagnose, self-treat, and self-monitor the

condition.

ii.FDA should exempt this class of hearing aids from QSR regulation in its present

form and substitute compliance with standards for product quality and

recordkeeping appropriate for the consumer-electronics industry, developed by an

appropriate third-party organization and approved by FDA. Similar actions should

be taken with respect to diagnostic hearing tests used to dispense and fit Class I

hearing aids.

President’s Council of Advisors on Science and Technology

PCAST Recommendations

Open the Market

Recommendation 2. FDA should withdraw its draft guidance of November 7, 2013 on

Personal Sound Amplification Devices (PSAPs).

•PSAPs should be broadly defined as devices for discretionary consumer use that

are intended to augment, improve, or extend the sense of hearing in individuals.

•PSAP manufacturers should continue to be able to make truthful claims about

their use in normal settings.

•FDA should not require language in PSAP labeling or advertising that excludes their

use by individuals with age-related hearing loss no worse than mild-to-moderate.

President’s Council of Advisors on Science and Technology

PCAST Recommendations:

Consumer Choice

Recommendation 3. Analogously to its “Eyeglass Rule,” FTC should require

audiologists and hearing-aid dispensers who perform standard diagnostic hearing tests

and hearing aid fittings to provide the customer with a copy of their audiogram and

the programmable audio profile for a hearing aid at no additional cost and in a form

that can be used by other dispensers and by hearing-aid vendors.

•Also analogously, the availability of a hearing test and fitting must not be

conditioned on any agreement to purchase goods or additional services from the

provider of the test.

President’s Council of Advisors on Science and Technology

PCAST Recommendations:

Consumer Choice

Recommendation 4. Similarly in effect to its “Contact Lens Rule,” FTC should define a

process by which patients may authorize hearing aid vendors (in-state or out-of-state)

to obtain a copy of their hearing test results and programmable audio profile from any

audiologist or hearing-aid dispenser who performs such a test, and it should require

that the testers furnish such results at no additional cost.

•While FTC has the authority to issue new regulations of this sort, action can be

accelerated and strengthened by legislative direction. We urge the Administration

to work with Congress to initiate bipartisan legislation that would instruct FTC to

issue a rule for hearing aids and PSAPs similar to the eyeglass and contact lens

rules.

President’s Council of Advisors on Science and Technology

Summary

•Large costs and risks from untreated hearing

loss

•Major barrier from hearing aid costs and limited

ability to shop for best value

•PCAST analysis finds a few key changes in

Federal regulations could accelerate needed

changes

President’s Council of Advisors on Science and Technology