The US Hearing Aid Boom: Decoding the FDA's OTC Rule and 2025 Market Strategy

Medical Device Global Market Access · Dec 8, 2025 · 2m

This episode explores the transformation of the U.S. hearing aid market following the FDA's landmark 2022 rule that established an over-the-counter (OTC) category. We analyze the impact on accessibility, device innovation, and affordability, while also examining the continued importance of the prescription hearing aid channel. The discussion covers early market analyses from 2024 and the outlook for 2025, highlighting the factors that make hearing aids a key medical device category. - What was the FDA's landmark hearing aid rule in 2022? - How did the creation of an OTC category change market…