https://www.fiercebiotech.com/medtech/bose-abandons-hearing-aid-plans-hands-direct-consumer-tech-lexie-hearing

Bose abandons hearing aid plans, hands off direct-to-consumer tech to Lexie Hearing

By Conor HaleAug 1, 2022 12:08pm

Bose SoundControl hearing aid
Though it received its initial green light from the FDA in late 2018, the launch of Bose’s SoundControl hearing aids eventually delayed until May 2021. Bose shut down its healthcare-focused division entirely this past March, amid layoffs reported by The Boston Globe. (Bose)

After being held up as a harbinger for consumer electronics companies dipping their toes into healthcare, the speaker maker Bose has found the water too cold. 

Bose shut down its healthcare-focused division entirely this past March, through workforce cuts that included about 245 people, according to reporting from The Boston Globe. Last week, the company confirmed in an announcement that it would no longer manufacture or sell its direct-to-consumer hearing aids at all.

Instead, Bose has found a new home for its technology, which was designed to allow wearers to program and control their hearing aids themselves without needing to visit the doctor. The company announced that it has partnered with Lexie Hearing to outfit the latter’s product lines: Lexie’s B1 hearing aids will now be branded as “Powered by Bose” software\ and carry an $899 price tag. 

That’s a little more than the original $850 price of Bose’s now-abandoned SoundControl hearing aids, but still far less than typical prescription devices that can range in the thousands of dollars.

The Massachusetts-based Bose has been laying off staff at a rate of about 1,000 people annually since 2019 and closed dozens of retail stores, according to the Globe—which cited strong competition in headphones and other products from tech giants such as Apple, plus missed sales goals for new products such as its hearing aids.

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Though it received its initial green light from the FDA in late 2018—less than a month after Apple unveiled its first agency-cleared, heart-tracking ECG smartwatch and made a separate splash in the medtech industry—the launch of Bose’s SoundControl hearing aids was eventually delayed until May 2021. 

Despite a full clearance, Bose’s device was not technically classified as an “over-the-counter” hearing aid by the FDA—or one that could be purchased just anywhere. That requires the agency to set up a new regulatory category for the device, a project that has been in the works since 2017 and most recently led to a proposed rule put forth by the FDA in October 2021.

“[Lexie’s] understanding of the complex, regulated hearing aid market, and ability to reach more of the millions of people who suffer from hearing loss today was also critical to our decision,” Nick Smith, Bose’s senior vice president of strategy and business development, said in a press release.

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Bose finally launches its direct-to-consumer SoundControl hearing aid

The agency’s new regulation would amend existing rules governing the sale of certain air-conduction hearing aids—sound amplifiers that are typically worn behind the ear or within the ear canal, without the need for an implant—while also addressing state-level controls that may require hearing aids to be purchased in-person from a licensed dispenser. Hearing aids and implants for severe hearing loss or for users under 18 would still require a prescription.

Last year during its initial rollout, Bose had aimed to sell its hearing aids straight to consumers where the laws allowed, starting in Massachusetts, Montana, North Carolina, South Carolina and Texas before making plans to expand.

Meanwhile, the Wall Street Journal reported last October that Apple could be exploring the addition of hearing aid-like functionality into their AirPod earbuds. The tech giant is also studying their potential as a health device to measure a person’s temperature and posture. Last year, Apple also launched a “conversation boost” feature that uses its microphones to amplify people talking in front of the wearer.

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