Rarely has such a hugely untapped but ready-made market opened at one time in the consumer technology industry. Nearly 40 million Americans suffer from some sort of moderate or mild hearing loss, but few could afford audiologist-prescribed hearing aid solutions. With the FDA’s recent announcement of a new category of over-the-counter (OTC) hearing aids creates a huge new opportunity for lower-cost solutions for Bluetooth in-ear bud makers and technology retailers to sell hearing aids directly to consumers.
“The launch of this new category will open up and drive innovation for hearing health, we’re excited to see what is to come,” says Kerri Haresign, CTA’s technology & standards director. “We look to bring the industry together to set up the best practices so others can grow and innovate beyond that.”
For the consumer, the main benefit of these new FDA regulations, which went into effect on October 17, will be lower-priced hear aids, the savings coming from both natural market competition and the elimination of an expensive audiologist. “A hearing-aid market disruption is underway,” agrees John R. Luna, CEO of Nuheara, makers of the IQbuds2 Max hearing-boosting earbud and who is partnering with HP to bring a lower-cost OTC hearing aid to market, and chair of CTA’s OTC Hearing Aid standards committee. “Consumer electronics retailers realize their loyal customer base that they have been serving for the last 20-30 years or more are beginning to need “health and wellness” products, including OTC hearing aids. More and more retailers will offer OTC hearing aids, and this will become the norm in the future.”
Recognizing the opportunity, Best Buy and Walmart/Sam’s Club each have already started selling OTC hearing aids in their online stores, and both big boxers have announced plans for opening in-store OTC hearing centers in the bulk of their stores.
So what do Bluetooth earbud vendors and retailers need to know to build and sell OTC hearing aids?
OTC Hearing Aid Product Classifications
The FDA has identified two types of OTC hearing aids: “exempt” aids that are not actually FDA cleared but only registered by the manufacturer with the FDA, and “self-fitting” aids that are 510(k) premarket cleared by the FDA to be safe and effective. Exempt aids lack frequency- and user-specific testing and settings unique to the wearer, and instead include subjective tuning or presets that allow the wearer to subjectively choose a setting that best meets their listening preferences. “Self-fitting” aids are more sophisticated, including frequency-specific customization and hearing testing for each ear to match the OTC hearing aids to the consumers’ actual hearing profile or loss.
“This 510(k) requirement is more demanding than launching a traditional hearing aid which needs to be fit by a licensed professional,” notes Philippe Jørgensen, VP of lifestyle hearing for GN, which owns Jabra and which just unveiled its first OTC hearing aid, the Jabra Enhance Plus ($799.99).
These two OTC hearing aid product classifications differ from existing Personal Sound Amplification Products (PSAPs), which simply raise volumes across the board and aren’t designed to address a user’s specific hearing loss. Hearing aids for children and for adults with more specific or severe hearing loss remain regulated prescriptive devices available only from audiologists and other medical professionals.
From these “exempt” and “self-fitting” parameters, manufacturers have several distinct form factors to choose from. The first is the traditional “invisible” or discrete styles that include completely in-canal beans or cones such as Sony’s new CRE-C10 ($999.99) or so-called “behind-the-ear” styles such as the Lexie B2 ($999.99), both styles designed to hide the stigma of a wearer’s hearing loss and to be worn continually. These traditional hearing aid styles usually are powered by long-lasting replaceable rather than rechargeable batteries.
Consumers, however, are now used to wearing in-ear Bluetooth buds and recharging them every few hours, so consumer earbud brands such as Jabra and its new Enhance Plus ($799.99), Sony with its CRE-E10 ($1299.99), and others are focusing more on this more modern, familiar in-ear bud style and recharging characteristics.
The Bluetooth Advantage
By adding hearing aid capabilities to the familiar in-ear Bluetooth bud form factor, users also will be able to hear adjusted music and phone calls as well. But coming soon will be new Bluetooth LE Audio capabilities designed specifically for hearing aids.
Chief among these new Bluetooth Audio hearing aid functions is Auracast, a wireless broadcast standard that will allow public venues such as concert halls, theaters, airports, houses of worship, museums, and the like to directly beam audio in multiple languages defined by the user to Auracast-compatible OTC hearing aids, rather than the user renting a T-coil system or relying on their hearing aids to pick up often garbled PA audio. Auracast “will allow for a completely new sound experience in public areas,” Jørgensen opines. “Similar to traffic information on the radio, users will be able to accept broadcasting content in the venues they find themselves in.”
OTC hearing aids fully compatible with Auracast will likely start appearing at CES. “The timeline for these [Bluetooth LE Audio] adoptions is hard to predict,” admits Jørgensen, “but is already ongoing, and will certainly have made significant progress in the next 3-5 years to come.”
OTC Hearing Aid Development Challenges
Not every in-ear bud maker will want to get into the OTC hearing aid business. For one thing, companies will have to deal with the FDA’s approval bureaucracy, which “require a company to comply with all hearing aid standards and in some cases prove safety and efficacy via a 510(k) premarket clearance submission,” Luna explains. Then there’s the IP piece, “patents and predicate devices that may prove an infringement issue that turns into a legal battle,” Luna adds.
As a result of these regulatory and IP hurdles, many earbud makers have partnered with established hearing aid companies – GN owns Jabra, for instance, Nuheara and HP, Sony with WS Audiology (WSA), and Bose with Lexie Hearing.
“Hearing science and hearing aid expertise on the team is preferred to not only understand the level of performance of the device and software but to also understand the human ear, ear canal and all the associated nuances they present in design and functionality,” Luna explains. “Then, having that hearing aid retail or hearing aid industry knowledge is important to understand the consumer and what they need and how to best develop a product that meets them in their lives. The combination of all these things is the hard part for every company.”
These OTC hearing aid development challenges, however, are unlikely to long forestall ambitious earbud makers anxious to profit from a new and potentially lucrative and obviously societally beneficial new technology category.
“Manufacturers – including those of traditional hearing aids – have been part of the process for years and already have hit the market,” observes CTA’s Haresign. “We anticipate that a main factor affecting timing is whether this is a brand-new device or validating one that was already on the market to meet the OTC guidelines. We expect to see established brands and new entrants into the field soon.”