The Essential Library of Key Publications on the CRE OTC Hearing Aids Strategy


CRE Initial Filing

OMB Submission

OTC Reg PSAP Guidance

WHO Technical

CRE OTC White Paper.Dec-15 (f)

WHO estimates reveal that :

  • More than 430 million people (5% of the global population) live with disabling hearing loss resulting from a range of causes. This number is projected to increase substantially in the next decades unless action is taken to mitigate the risk factors for hearing loss.
    • 1.1 billion young people worldwide could be at risk of hearing loss as a result of unsafe listening practices.
    • Among teenagers and young adults aged 12–35 years in middle and high-income countries:
    – nearly 40% are exposed to potentially damaging sound levels in  recreational venues such as nightclubs, discotheques, and bars.
    – nearly 50% face the risk of hearing loss due to listening at high volumes or for prolonged time periods over their personal
    audio systems.

The FTC’s Invaluable Enforcement Program to Aid Compliance with FDA Hearing Aid Regulations

The Federal Trade Commission has been most vigilant in assuming a prominent role in promoting the health of our citizenry by taking the needed steps to ensure PSAPs are used as intended, as so described by the U.S. Food and Drug Administration. The FDA states that hearing aids and PSAPs differ “in that only hearing aids are intended to make up for impaired hearing…”. Choosing a PSAP as a substitute for a hearing aid can lead to more damage to your hearing.” To this end, in recent litigation, the FTC settled a suit against a party who overstated the merits of a sound amplifier and stated that it was suspending a judgment of $47 million given the defendants agreement to “an order that will require them to have human clinical testing to support future representations.”