OTC Hearing Aids One Year Later – Mission Accomplished?

The White House blog of August 2022 announcing the FDA’s release of the Over-the-Counter (OTC) hearing aid rule, which would take effect that October, highlighted the rationale for its creation: “Drive down costs, increase access, and open up a market space for creative innovation.” Andrew Bellavia (AuraFuturity) writes about the first year of the Over-the-Counter (OTC) hearing aid rule. It seems that just 2% of those with hearing difficulties purchased an OTC hearing aid in this time.

Knowles Corporation is showcasing its latest solutions optimized for over-the-counter (OTC) hearing aids at the CES 2023 show in Las Vegas. The new product releases unveiled ahead of the show offer performance and design flexibility to accelerate the production of hearing health products. Three full-range balanced armature receivers and two updated MEMS microphones will fulfill the rigorous demands of hearing aid design and acoustic performance.

Five years after the original OTC hearing aid act was signed into law on August 18, 2017, the US Food and Drug Administration (FDA) issued a final rule establishing Over-the-Counter (OTC) hearing aids. The FDA also issued the final Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products, clarifying the differences between hearing aids, which are medical devices, personal sound amplification products, and the new category of OTC hearing aids, which can be purchased directly from stores or online.

The U.S. Food and Drug Administration (FDA) allowed marketing of a new device, the Bose Hearing Aid, intended to amplify sounds for individuals 18 years or older with perceived mild to moderate hearing impairment (hearing loss). This is the first hearing aid authorized for marketing by the FDA that enables users to fit, program and control the hearing aid on their own, without assistance from a health care provider.