Bose didn’t wait for the starting gun to go off in the race to market low-cost, high-tech over-the-counter hearing aids. Instead, after clearing a little-known FDA fast-track approval process, Bose is set to launch “the first hearing aid…that enables users to fit, program and control the hearing aid on their own, with or without assistance from a health care provider.”
The success of the Bose product ultimately will depend on price, product features, and availability—all still currently unknown. But even the simple presence of a self-fitting direct-to-consumer hearing aid from Bose will be a game-changer for the industry.
Bose has not yet introduced or announced the new product, but a news release from the FDA describes it in some detail:
The Bose Hearing Aid is a user-fitted wireless air conduction hearing aid….Patients can adjust the hearing aid through a mobile application on their phone. This technology enables users to fit the hearing aid settings themselves, in real-time and in real-world environments without the assistance of a health care professional.
Unlike most hearing aids, which are fitted and sold by audiologists or other hearing professionals, the new Bose hearing aids may be sold directly to the consumer without a medical intermediary. Hearing aids normally must be approved by the FDA as Class 1 medical devices. Among other things, FDA-approved hearing aids can only be sold after a medical professional has examined the patient and recommended hearing aids, or after the patient has signed a waiver to acknowledge the risks in bypassing a medical examination.
Jumping through those hoops has depressed demand from potential buyers and discouraged sellers from marketing low-cost direct-to-consumer hearing aids. That hasn’t stopped several suppliers of lower cost hearing aids from selling directly to consumers who sign medical waivers. For nearly a decade, MD Hearing Aid and iHear Medical have both successfully sold FDA-approved hearing aids direct over the internet at prices far lower than consumers pay audiologists. But until now, global consumer brands such as Apple, Samsung and Bose—which all have active hearing aid R&D programs—have kept their powder dry.
When Congress enacted the OTC Hearing Aid Act in 2017, it set a timetable for establishment of a new class of over-the-counter hearing aids that will no longer require prior physician approval. But it won’t be until the summer of 2020 that the final product specifications and distribution rules are set. In the meantime, manufacturers have been lining up product and distribution plans for what is expected to be an exciting new era of hearing-aid industry competition beginning in 2020 or 2021.
But the FDA’s Bose announcement now has radically changed the equation. The Bose Hearing Aid was reviewed under the FDA’s fast-track De Novo premarket review—“a regulatory pathway for some low- to moderate-risk devices that are novel and for which there is no prior legally marketed device.” That pathway will lead Bose directly to the consumer market as soon as its new hearing aids are ready—sidestepping the longer process of waiting for FDA product approvals under the OTC Hearing Aid Act.
If Bose launches its hearing aids soon—especially with wireless features consumers have come to expect from high-end headphones, and at prices somewhere south of $1,000 for a pair—it will send shockwaves through the hearing aid industry. Why? Because the average cost of hearing aids from one of the six manufacturers who control more than 80 percent of the global hearing aid market currently range anywhere from $2,500 to $6,500 a pair, depending on the features included.
Unlike other consumer tech markets where costs have come down consistently for decades, hearing aids have maintained stubbornly high price points. When big consumer electronics players like Bose (and Apple? and Samsung?) start entering the market, with their advanced R&D capabilities, global distribution, and mass-production economies of scale, it will be a new game entirely.