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 near future.
Hearing Loss is a Major Health Problem
The overarching concern expressed by PCAST, according to the teleconference on October 23 was “an urgent need to improve hearing for older adults.” This finding is based on data presented to PCAST indicating hearing loss in older adults in a major health and social problem, growing in importance with the aging population, and, further, few adults with hearing loss are using hearing aids.
The PCAST report outlines several barriers related to the relatively low uptake of hearing aids today, including
- high cost
- lack of insurance coverage
- social stigma
- complex consumer regulations & restrictions
- lack of engagement by health providers.
Recommendations for a Market Ripe for Change
A key consideration of the PCAST committee was that new technology is advancing rapidly, making the current marketplaces for hearing care service delivery ripe for change. PCAST provided three goals for their recommendations:
- Reduce costs for consumers
- Increase the number of people who use hearing technology
- Stimulate innovation and technology development
To achieve these goals, PCAST recommended the following, taken directly from their document issued on 10-23:
- Open the Market. 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.
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.
- Open the Market by allowing the FDA to withdraw its draft guidance of November 7, 2013 on Personal Sound Amplification Products (PSAPs)a. 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.b. PSAP manufacturers should continue to be able to make truthful claims about their use in normal settings.c. 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.
- Enable more Consumer Choice. 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.
a. 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.
- Enable more Consumer Choice. 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.
a. 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 believes that a few key changes (recommendations 1-4 above) in Federal regulations could accelerate needed changes in uptake of hearing care by more adults.
Later that day, the Hearing Instrument Association (HIA) issued a strongly words statement opposing the PCAST recommendation for many reasons outlined in their recent report.
