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For a well-established product like the hearing aid, the market is a dynamic one with incredible growth opportunities.
“There’s only about a 20% penetration in the space,” reported Dave Olson, CEO of Elevated Technologies/Elevated Hearing. “A lot of people can’t afford hearing aids or think wearing them would be unappealing. But there are a lot of forces at work to make them more appealing and affordable.”
The market for these devices is growing about 8%, according to market research firm ResearchAndMarkets, whose estimates predict the global market will reach $9 billion by 2023.
Olson spoke recently during the MD&M Minneapolis 2018 panel discussion, “Next-Gen Hearing Aid Technology and Design Trends.” He was joined by Aaron Jones, senior director, product management & practice development for Unitron US; and Paul Mazanec, CTO & VP of research & development for Esteem Hearing Implant. The panelists discussed technological evolution and changes yet to come and even offered a few lessons for designers of any type of medical device.
The panelists pointed to a number of factors driving change and growth, transforming the niche that began more than 100 years ago. Today’s hearing instruments offer patients the latest in capability, durability, and battery power. Hearing aids are also interacting with—and being controlled by—smartphones. The panelists said there isn’t a limit to how sophisticated that interaction could be. For instance, many hearing aids already stream audio without an intermediary device, said Olson. "Soon the hearing test itself could be conducted by the same streaming function and fine-programming further adjusted by the consumer or remote clinician… all because hearing aids can connect to smart phones," he told MD+DI. Separately, "yet every bit as exciting," said Olson, advances in active implantable medical devices to treat hearing loss are offering patients seamless and invisible treatment along with convenience and comfort.
Growth in the consumer tech market has influenced the hearing aid market. It used to take about 7 years for consumers to admit they needed some sort of hearing assistance, Jones said, but that timeframe seems to be dropping a little now. Consumers may be more open to using technology, and given the advancements, hearing aids may feel more like a consumer device these days.
Hearing devices have become more durable for long life spans. In terms of materials and design, the panelists discussed several changes over the years. Jones of Unitron pointed to plasma treatment and nano-coatings that increase device durability. Mazanec said on the implant side, there’s a need for low-cost, long-lasting biocompatible materials to support implant lifetimes of multiple decades.
Mazanec added that there’s interest in low-power consumption devices to reduce the size of the battery. "For both traditional and implanted devices, the battery limits the physical size of the device," he said. "Along those same lines, there is also work toward increasing energy density in batteries and even using rechargeable devices." Added Jones: “We recharge our phones every day, so the perceived burden of charging hearing aid batteries seems less than it used to be. We are transitioning from zinc-air batteries to rechargeable ones as technologies advance. Today many hearing aids use silver-zinc or lithium ion rechargeable batteries.”
To address affordability, Mazanec said that “there is some movement in terms of coverage or reimbursement for implantable devices for people who do not receive benefit from externally worn hearing aids.” And Jones said managed care organizations and third-party referral networks are negotiating reduced hearing aid pricing for hearing care consumers.
Moving toward some sort of over-the-counter device may also address affordability. Congress directed FDA to create a category of over-the-counter (OTC) hearing aids and associated rules; FDA has until 2020 to publish these proposed regulations. In the meantime, FDA has authorized a hearing aid (sold by licensed hearing aid dispensers) that allows patients to fit, program, and control the devices without the assistance from a hearing care provider.
But such self-serve devices aren’t without their challenges—professional input can be valuable. “Expectation management for patients is provided by audiologists,” said Mazanec. “And they counsel and coach patients.”
Aftercare is also needed. “Ears generate wax, and with the wear and tear of everyday use, hearing aids require maintenance,” said Jones.
“And there will always be a benefit to a curated, professional fit,” said Olson.
However, performance is improving for “open-fit” devices, Olson added. And “open-fitting technology allows hearing aids to use ear tips of various sizes instead of custom fitting, which was previously used to control feedback. For severe hearing loss, custom fitting is still best, but for more common mild to moderate hearing losses, open fitting is a game changer.” Such improvements have moved the industry away from mass customization to an extent, which does involve more-complex manufacturing and logistics, despite early adoption of 3D scanning or 3D printing technologies.
During the panel discussion, an audience member inquired about cybersecurity risks with connected devices. “The security around the smartphone/human interaction is generally considered the weakest security link,” said Olson. However, “Bluetooth interactions with accessories are quite robust and not generally thought to have significant security concerns. The Bluetooth standards people seem to have it buttoned up.”