(Reuters) - The U.S. approval of audio products maker Bose Corp’s new hearing aid, which can be used without a doctor’s assistance, could pressure traditional makers of the devices struggling to keep up with demands from more tech-savvy users.

The approval here sent shares of hearing-aid makers sliding, including those of market leaders William Demant and Sonova Holding AG.

The Bose Hearing Aid is a user-fitted hearing aid that can be adjusted through a smartphone app, enabling patients to fit the hearing aid settings themselves.

“With the approval of the Bose hearing aid, it appears at least one consumer electronics manufacturer is looking to target this market,” Bernstein analyst Lisa Clive wrote in a note.

“It will be interesting to see if this is the first of a number of new entrants. For instance, we know Samsung has looked at hearing aids in the past.”

The FDA is in the process of drafting regulations regarding new over-the-counter category of hearing aids that are expected to be implemented in 2020.

About 37.5 million adults report having some trouble hearing without a hearing aid, the FDA said. Hearing loss can be caused by aging, exposure to loud noises, certain medical conditions and other factors.

While users may fit, program and control the Bose Hearing Aid on their own, the device must comply with applicable federal and state laws regarding the sale of hearing aids, the FDA said.

Credit Suisse analyst Christopher Gretler said Bose’s ambitions in hearing devices have been evident ever since it started to sell the Bose Hearphones, a conversation-enhancing headphone that is specially designed to help hear in louder environments.

Shares of William Demant, GN Store Nord and Sonova fell nearly 10 percent and were at the bottom of the pan-European STOXX 600.