Report on Aging America & Hearing Loss: Imperative of Improved Technologies
Report issued by the President’s Council of Advisors on Science and Technology (PCAST)
The PCAST report (issued October 27, 2015) focuses on the nearly 30 million adults over the age of 60 who have age-related, progressive, mild-to-moderate hearing loss. Only a small percentage of people with hearing loss (according to the report about 15-30 percent) seek treatment. There are several factors contributing to this low number, but the PCAST report points out that two of the driving factors are that the market is characterized by high cost and low innovation, and that the current distribution channels create a barrier to access.
As a result of these findings the Council has made four recommendations in their report to the president:
- · FDA [Food and Drug Administration] should approve a distinct class of hearing aids for over-the-counter (OTC) sale, without the current requirement for consultation with a “credentialed dispenser” such as an audiologist, ear, nose and throat specialist, or licensed hearing aid specialist.
- · FDA should withdraw its draft guidance on Personal Sound Amplification Products (PSAPs). A PSAP is a wearable consumer electronic device intended for non-hearing impaired people to amplify sounds in certain environments. If effected, the 2013 guidance would forbid PSAP manufacturers from making truthful claims about the functionality of the product in certain situations because those claims could label the device a “hearing aid.”
- FTC [Federal Trade Commission] should require hearing-aid dispensers who perform standard hearing tests and hearing aid fittings to provide the customer with a copy of their results at no additional cost and in a format that can be used by other dispensers and vendors.
- · FTC should define a process to authorize hearing aid vendors to obtain a copy of a customer’s hearing test results and programmable audio profile from any audiologist who performs such a test, and do so at no additional cost to the customer.