The END of Dispensing Hearing Aid Professionals?
On April 27, 2009, President Obama announced the President's Council of Advisors on Science and Technology (PCAST). PCAST is an advisory group of the nation’s leading scientists and engineers who directly advise the President and the Executive Office of the President. PCAST makes policy recommendations in the many areas where understanding of science, technology, and innovation is key to strengthening our economy and forming policy that works for the American people.
October 2015 PCAST released a report and their recommendations for Accessible and Affordable Hearing Health Care for Adults.
If their recommendations come to fruition, ALL dispensing Audiologists and Hearing Aid Specialists will cease to exist.
Please read their recommendations and pass it on to as many dispensing professionals as possible. To wait and see what will happen is a kiss of death to our professions.
PCAST makes the following recommendations:Open up the market for innovative hearing technologies
Recommendation 1. FDA should designate as a distinct category (“basic” hearing aids) non-surgical, air conduction hearing aids intended to address bilateral, gradual onset, mild-to-moderate age-related hearing loss and adopt distinct rules for such devices.
(a) 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.
(b) 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.
Recommendation 2. FDA should withdraw its draft guidance of November 7, 2013 on Personal Sound Amplification Products (PSAPs).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.
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.
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.
In summary, PCAST finds that the costs and risks of inaction with respect to untreated hearing loss in the aging U.S. population are large. PCAST finds that the unnecessarily high price of hearing aids for individuals and the conspicuously slow pace of innovation by their manufacturers compared with other consumer electronics are consequences of a concentrated and increasingly vertically integrated incumbent industry, operating in the context of longstanding Federal and State regulations that appear to discourage potential new entrants. PCAST recommends specific actions by FDA and FTC that would have the effect of opening up the market for innovative hearing technologies and increasing opportunities for consumer choice.
Solution:Option #1) We can all sit around and wait to see what happens and hope it just goes away. Option #2) ALL dispensing hearing aid professionals including Audiologists and Hearing Aid Specialists to join together and fight this as ONE group ( Better choice!)
Your opinions are welcome!