CHALLENGE:
Hearing aids, including Over-the-Counter (OTC) hearing aids, improve quality of life for millions of people around the world—boosting communication and cognitive function, while reducing stress and anxiety associated with hearing loss. For decades, hearing aids in the U.S. were only available through licensed professionals by prescription, limiting accessibility. As technology advanced, there was an opportunity to bring forward a new wave of affordable hearing devices that could be available direct to consumer. However, there was a need to ensure that these devices met the necessary bars for safety and efficacy.
SOLUTION:
The Consumer Technology Association (CTA) worked with manufacturers and hearing experts to create a quality standard for hearing devices: ANSI/CTA-2051, Wearable Sound Amplifier Performance Criteria. In 2022, the Food and Drug Administration approved OTC heading aids for adults with mild to moderate hearing loss, and adopted elements of the CTA standard to underpin the regulation.
IMPACT:
The creation of OTC hearing aids marked a new chapter in hearing health driven by the CTA’s standard–an example of how standards help amplify innovation and effectively support safety. For the first time, consumers could purchase hearing aids without a prescription, while still being assured that safety and quality parameters were met. With the application of ANSI/CTA-2051, consumers are empowered to make informed purchasing decisions, while manufacturers are incentivized to elevate device quality.
Sources:
Guidelines:
Case studies will be added to the Standards Boost Business webpage at ANSI’s discretion.
