FDA Approves an OTC Hearing Aid

For the past year or so since the Over-the-Counter Hearing Aid Act of 2017 was passed, I and other hearing-loss advocates have patiently explained time and again that right now there are no OTC hearing aids. That’s because the FDA approval process includes a three-year comment period before it publishes its final regulations. And until that time, only hearing “devices” can be sold over the counter.

Or at least that was what we thought. Last Friday (October 5), the FDA took almost everyone by surprise when it announced that it had approved a Bose hearing aid that consumers will fit and program themselves.

The Bose Hearing Aid, the FDA announcement said, is intended for adults over 18 with perceived mild to moderate hearing loss. “This is the first hearing aid authorized for marketing by the FDA that enables users to fit, program and control the hearing aid on their own, without assistance from a health care provider,” the announcement said. The wireless device processes sound through an earphone in the ear canal, and the user programs the aid on a smart phone.

The FDA does require compliance with sales regulations, “including state laws that might require hearing aids to be purchased from or dispensed by a licensed hearing aid dispenser.”  I’m not sure how many states have that regulation. Would welcome enlightenment.

The Bose Hearing Aid is not yet available, nor has the price been set, but Bose has landed a huge coup. As Abram Bailey at Hearing Tracker noted, “Bose has effectively been granted a very unique position by the FDA.”

The Bose Hearing Aid will be a new product, according to Sandy Weiss at Bose, rather than an adaptation of Bose’s Hearphone, which is a PSAP. As for when they will be available, Ms Weiss said in an email, there is as yet no new product announcement or distribution plan. She added that while details about future pricing are confidential, Bose does “expect to offer more affordable solutions than traditional hearing aid solutions currently on the market.”

So what made the FDA decide to approve this particular hearing aid? After reviewing data from clinical studies of 125 patients the FDA found the results persuasive enough that it approved the Bose Hearing Aid under its De Novo premarket review pathway. The De Novo pathway allows expedited approval of “low- to moderate-risk devices that are novel and for which there is no prior legally marketed device”. (Click here to see a list of other devices approved under the De Novo pathway so far in 2018.) Not only were the results of self-fitting comparable with those of a hearing professional, the FDA noted, but participants in the trial generally preferred their own settings over those selected by a hearing aid professional.

The announcement was made after the close of the European stock markets on Friday but by 10 AM Eastern time on Monday, the shares of the Danish companies GN Store Nord and William Demant Holding had each fallen by 13 percent, with Switzerland’s Sonova dropping 10 percent The American markets saw a similar drop. Obviously Bose, a privately held company, is seen as a threat to conventional hearing aid sales.