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Following the news that the Food and Drug Administration (FDA) is drafting proposed regulations for a new type of hearing aid for people that struggle with background noise or find hearing in social situations challenging, GlobalData notes that growth and innovation within consumer medical devices will likely catalyse increasing volumes of over-the-counter (OTC) product launches, including hearing aids. However, the leading data and analytics company also highlights the case of Bose, which pulled out of the OTC hearing aid market last year after underestimating its ability to draw new patients, to show the difficulties of entering this market.

GlobalData’s Medical Intelligence Center reveals that there are currently over 50 companies globally marketing more than 430 hearing aids, with most sales based in the US and Europe. These companies are catering to the hundreds of millions of people worldwide that are affected by hearing loss. It is apparent that there is huge potential for a MedTech company to tap into the market.

Brian Hicks, Senior Analyst at GlobalData, comments: “If they are done right, OTC hearing aids are expected to be more affordable and accessible options. However, Bose’s experiences remind us of the challenges of this market.”

Bose received a 510(k) clearance from the US FDA for the first-of-its-kind, OTC hearing aids back in May 2021. The audio equipment manufacturer faced mixed public opinions on expanding its market reach into this notoriously under-penetrated market. Despite the carefully limited initial launch of its SoundControl Hearing Aids, and setting a far more affordable price point against its competitors, the challenges of capturing adequate market share proved to be unsustainable for Bose, resulting in its quiet exit of the market.

Bose historically focused on consumer products within the audio industry such as headphones and speakers—often leading the industry with new technologies, most notably active noise cancellation. More recently, it developed the opposing technological application of sound amplification technology as it saw a market opportunity for treating millions of adults with mild to moderate hearing loss.

Hicks adds: “Despite the enormous potential, the hearing aids market has historically faced significant reluctance among its potential users. This is especially true among older patients, which make up most cases, where their self-reliance and desire to maintain their prior lifestyle become obstacles to product adoption.

“Even in cases where their biases don’t dictate their choices, the sheer unaffordability of hearing aids prices out many. Bose overestimated its ability to draw new patients and cement itself as the sole player within the OTC hearing aids market.”

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