By David H. Kirkwood
SAN FRANCISCO/SAN LEANDRO—Hardly a week passes without at least one announcement of some new device being developed to help people with hearing loss. Whether these products are categorized as hearing aids, personal sound amplification products (PSAPs), or assistive hearing technology, they nearly all have a few things in common:
(1) Although they are designed to serve much the same function as hearing aids manufactured and marketed (in the U.S.) in accordance with Food and Drug Administration (FDA) regulations, the manufacturers of these new products do not seek FDA approval. (Whether or not they should be required to is a matter of debate.)
(2) Unlike FDA-regulated hearing aids, which are normally dispensed by state-licensed audiologists and hearing aid specialists, these new devices are sold directly to consumers.
(3) These non-regulated products are generally much less expensive and easier to buy than conventional hearing aids.
SOME LEADING LIGHTS ARE INVOLVED
Although low-cost amplification products have been sold to hard-of-hearing consumers by mail order and over the counter for decades, recent advances in technology have led to an explosion of such devices. And, unlike the $39 or $99 devices that were marketed on 3 am TV advertorials and in the back pages of magazines, some of the latest hearing assistive products come with impressive pedigrees.
One of these is Soundhawk, developed by the San Francisco-based Soundhawk Corp. The company announced earlier this month that it has raised $5.7 million in venture capital. No doubt the fact that Soundhawk’s founder and chairman is Rodney
Perkins, MD, has helped attract investors.
Perkins, an otologist at Stanford University School of Medicine, is best known in the hearing aid industry as founder and former chairman of ReSound Corporation. ReSound, launched in 1984 and sold in 1999 to its current owner, GN Store Nord of Denmark, is the most successful new hearing aid company of the past 30 years and one of the world’s “big six” hearing aid manufacturers.
Perkins, a serial entrepreneur, also established the California Ear Institute at Stanford and is the founder and chairman of several other health care companies.
Soundhawk, which has been under development for several years, is expected to be available in the first half of 2014. In a recent press release, Perkins said that the new product “is the culmination of a lifetime of hard work in the hearing sciences to bring a life-changing device to the mass market. Soundhawk has the potential to fundamentally improve the lives of hundreds of millions of people.”
The company describes its product (not modestly) as “a small, elegantly designed wearable device [that] will work with a simple but powerful smartphone app to instantly personalize Soundhawk to your unique hearing profile and environment.” It claims that the device “will combine a unique blend of intuitive consumer technology and patented hearing science to enhance one of our most important senses–hearing.”
Meanwhile, iHear® Medical, of San Leandro, CA, another company headed by a prominent entrepreneur, has announced that it will introduce “the world’s first web-enabled hearing aid,” which will “change the way consumers cope with hearing loss.”
iHear’s president and founder is Adnan Shennib, a pacemaker engineer who worked under Rodney Perkins when he joined ReSound in 1988 as director of new technologies. After leaving ReSound, Shennib invented and developed the Lyric hearing device at InSound Medical, which he founded in 1998. Sonova, parent company of Phonak, purchased InSound for $169 million in January 2010.
iHear asserts that its technology will offer “advanced hearing solutions at a fraction of the cost of available hearing aids,” and in smaller sizes “for invisible wear. It also promises to give consumers online tools so they can “administer the entire fitting process, from hearing testing to individualized calibration of the hearing device—all from the convenience of home.”
To help make its product more affordable, iHear Medical says that it plans to offer payment options, including annual subscriptions and down payments as little as about $30.
Part of his vision, says Shennib, is to provide free hearing aids to people with low income through iHear Medical’s Hearing for All™ initiative. At the China Medtech Partnering Conference held in November 2013 in Suzhou, China, he announced that the program is being developed in collaboration with hearing advocacy groups and charitable foundations. He stated, “By offering the gift of hearing to those who cannot afford hearing aids, we are adding another dimension and purpose to our mission.” Further details about Hearing for All are scheduled to be revealed in January.l
iHear Medical is a venture-backed firm incubated by the Center for Medical Device Innovations, Inc. (CMDI), which focuses on developing platform technologies that create paradigm shifts in healthcare delivery. The company has raised several million dollars in financing.