The State of OTC Hearing Aids, One Year Later
October 17, 2023
- Kerri Haresign, CTA Sr. Director, Technology and Standards
On October 17, 2022, the lives of millions of adults with mild to moderate hearing loss in the U.S. changed. That’s the day they were able to buy over-the-counter (OTC) hearing aids for the first time. One year later, brands have come to market with hearing solutions that are accessible, innovative and life-changing for countless Americans.
CTA Standards
Hearing health has become part of common and broader conversations, with more younger people taking advantage of this technology. Moreover, studies show that hearing loss is one of the most significant risk factors for developing dementia. Consumers now will have the tools and resources to monitor their hearing health.
How CTA Helped Get Us Here
CTA was a driving force in the development of the OTC hearing aid for more than a decade. It was the culmination of work by member companies that developed the relevant, innovative technologies, and that participated in critical advocacy efforts with regulators and lawmakers. Our powerful collaborations also resulted in industry best practices ensuring that technology meets the necessary performance requirements. Here’s some background.
In 2014, CTA President and CEO Gary Shapiro joined with CTA leaders and members to discuss how innovative solutions could revolutionize the hearing aid market. They crafted a proposal for advancing approval of OTC hearing aids that also addressed needed regulatory reform. CTA mobilized to lobby lawmakers and, ultimately in August 2017, the U.S. Senate voted to pass the OTC Hearing Aid Provision.
Simultaneously, CTA’s American National Standards Institute (ANSI) - CTA’s accredited standards-development program - began work on, and published in January 2017, ANSI/CTA-2051, Personal Sound Amplification Performance Criteria. This industry-consensus standard would ultimately become a backbone for the FDA rule published in August 2022 authorizing OTC hearing aids.
What to See for Hearing Innovation at CES 2024
In January, at the world’s most powerful tech event, a wide range of digital health technologies – including those for hearing loss - will once again be on display. For example, Nuheara will be on the show floor to demonstrate its latest technology and sleek earbuds. CTA profiled Nuheara earlier this year, and featured its accomplishments via podcast in an episode of CES Tech Talk.
Additionally, Dr. Frank Lin of Johns Hopkins discussed developments since the 2022 roll out and expand on how OTC hearing aids have cut costs, as well as social isolation, for the many people experiencing hearing loss during “OTC Hearing Aids - An Update.” at CES 2024. Attendees also heard insights regarding the challenges and opportunities as the hearing aid landscape shifts to mass-market selling.
The Work Continues
CTA’s Health Fitness and Wellness standards committee has continued to develop standardization to drive innovation in the hearing health space. Earlier this year, CTA published this standard: Four Frequency Pure Tone Average Testing Methodology and Reporting Metrics for Consumer Facing Hearing Solutions (ANSI/CTA-2118). It identifies the elements of a standard testing methodology for consumer-facing hearing metrics. It also establishes common terminology to describe hearing wellness throughout a consumer's lifetime.
Understanding our hearing health is critical to living a long and productive life. This standard helps provide technology companies with the guidelines needed to innovate, and develop products that support consumers. The objective is to ensure that consumers can leverage the right technology, such as OTC hearing aids, to track and understand their hearing health.
