New entrants may shake up hearing-aid market after FDA clears path for OTC sales – MedTech Dive

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With the Food and Drug Administration clearing the path for over-the-counter sales of hearing aids, a mix of new entrants including startups, big tech companies and retailers such as Best Buy is expected to shake up the sector and eventually drive down costs for consumers, according to industry members and experts.

Patients could see over-the-counter hearing aids hit shelves as soon as October after the FDA on Tuesday published a final rule creating a category of devices that don’t require a prescription for adults with mild to moderate hearing loss. 

A goal of the legislation is to reduce prices by allowing consumer electronic companies to get into a space dominated by a handful of hearing-aid manufacturers, including ReSound, Sonova, and William Demant, analysts with Cowen wrote in a research note on Tuesday. 

Some companies have already begun offering over-the-counter hearing aids after Congress passed legislation in 2017 requiring the FDA to create the category of devices. Bose, known for its audio equipment, got FDA clearance in 2018 for the first over-the-counter hearing aid. But earlier this year, the company stopped making hearing aids, cutting its health division. It struck a partnership with South Africa-based Lexie Hearing to sell a direct-to-consumer hearing aid “powered by Bose.” 

Lexie is taking the technology developed by Bose and adding remote support, rewards and a team of audiologists to help people adjust their hearing aids as needed. It also has its own direct-to-consumer device. Once the final rule goes into effect on Oct. 16, the company plans to start selling products in the over-the-counter category of hearing aids, said Lexie COO Seline Van der Wat. 

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Source: https://www.medtechdive.com/news/companies-start-selling-over-the-counter-hearing-aid/629883/