In May last year, Bose received 510(k) clearance from the US Food and Drug Administration (FDA) for the first over-the-counter (OTC) hearing aids. Since then, the audio equipment maker has faced mixed public opinion about expanding its reach into the notoriously underpenetrated hearing aid market. Despite the carefully limited initial launch of its SoundControl hearing aids and pricing it much more affordably compared to competitors, the challenges of capturing adequate market share proved unsustainable for Bose, resulting in its low-key exit. market at the beginning of the month. .
Bose has historically focused on consumer products within the audio industry like headphones and speakers, often leading the industry with new technologies including active noise cancellation. More recently, the company developed the opposite technological application of sound amplification technology, as it saw a market opportunity to treat millions of adults with mild to moderate hearing loss.
GlobalData’s analysis reveals the huge number of prevalent hearing loss cases worldwide, which exceeds hundreds of millions. Even considering just the United States, the potential becomes clear for a MedTech company, or even a non-traditional company like Bose, to tap into their market to grow sales of hearing aids that don’t require surgeries like the do cochlear or middle ear implants. Despite the huge addressable market, the hearing aid market has always faced significant reluctance among its potential users. This is especially true in elderly patients who make up the majority of cases, where their autonomy and desire to maintain their previous lifestyle become barriers to product uptake. Even for patients whose biases do not dictate their choices, the unaffordable price of hearing aids excludes many.
Most medical devices, especially when available over-the-counter, do not meet with much reluctance given the health and wellness benefits that patients can enjoy. Given the relatively unique position of the hearing aid market in the MedTech market, Bose had most likely overestimated its ability to attract new patients to establish itself as the sole player in the over-the-counter hearing aid market. It also serves as a reminder of the many challenges companies face when expanding into new markets, especially when trying to monopolize them initially.
According to GlobalData, there are currently over 50 companies worldwide marketing over 430 hearing aids, with most sales based in the United States and Europe. Although no other company has purchased over-the-counter hearing aids since Bose’s departure, the broader growth and innovation of consumer medical devices will likely catalyze increasing volumes of over-the-counter product launches, including including hearing aids.