Three years ago, Rong Zhu Gan predicted her totally implantable hearing system (TIHS) would be fabricated, FDA approved, developed into a product and brought to market in 2012. With two years left, she's already achieved the first two objectives, bringing her closer to her goal of giving the gift of sound to more people experiencing hearing loss.
"Conventional hearing technology has advanced tremendously," said Gan, professor of biomedical and mechanical engineering and endowed Charles E. Foster Chair in Mechanical/Biomedical Engineering at the University of Oklahoma. "However, conventional technology suffers from drawbacks such as unsatisfactory sound quality, limited frequency range, undesired distortion, blocking of the external ear canal, acoustic feedback with high amplification and social stigma. This is why I've set my sights on working toward a product that would eliminate the stigma and awareness of a hearing device."
Hearing loss affects up to 10 percent of the population in the United States. The prevalence increases with age, and more than one-third of people older than 65 years have a significant hearing loss. Only approximately 20 percent of people with hearing loss seek assistance from hearing aids. Of these, as many as 20 percent do not wear their hearing aids and another 17 percent are dissatisfied with them, according to Jack A. Shohet, M.D., Otolaryngologist, Shohet Ear Associates Medical Group, Inc., in an article on eMedicine.medscape.com
Gan established a biomedical research home at the OU College of Engineering in 1999. Since then, she has received more than $2.97 million in funding for auditory research - specifically, the measurement of sound/vibration transmission through the ear. She uses new technology and modeling to better understand and utilize auditory frequencies and developed an implantable hearing device, completely invisible from the outer ear.
Mark Wood, M.D., otologic and neuro-otologic surgeon at the Otologic Medical Clinic and the Hough Ear Institute in Oklahoma City, collaborates with Gan and other biomedical researchers on a weekly basis to discuss research questions related to hearing loss.
"Implantable middle ear devices are medically desirable for people with certain ear deformities or skin conditions that preclude the use of conventional aids," Dr. Wood said. "Some types of hearing loss may be better served by implantable devices because they provide qualities of sounds that are not achievable with conventional aids."
Tony Howard, a patient of the Otologic Medical Clinic, who after wearing bilateral hearing aids for 12 years now has bilateral cochlear implants, said, "The drawbacks of hearing aids are in the aesthetics. People don't like the way hearing aids look in their ears. With my cochlear implants, I was able to do things again, normal things, like talk on the phone, hear music, play the guitar, participate in meetings, and so on. I believe the more hearing is restored to 'normal' hearing through amplification or implants, the less embarrassed those with a hearing impairment will feel around the mainstream population."
Dr. Wood said, "A totally implantable system removes the stigma of hearing loss and the usual upkeep from a person's daily life. But it's costly. More investigations will have to be done to determine if these systems are better than conventional aids for each individual case."
Gan's technology could potentially replace hearing aids, cochlear implants and other implantable hearing devices; therefore, she is developing a product that has better functionality, minimizes the risk to patients' hearing and is comparable to conventional digital hearing aids in cost/benefit ratio. She said the TIHS is a more compatible fully implantable or totally implantable hearing device with less complexity, lower cost and minimal surgical implantation.
"This technology is primed and ready to go. We need a company to take the TIHS technology into the market. The ideal company would have existing products or distribution channels that reach the 38 million Americans who have moderate-to-severe hearing loss," Gan said.
Howard said, "We live in a world of language; being able to speak and listen are critical to quality living. There was a day when people who are deaf or hard of hearing had no other options, but not today. I've seen so many expensive hearing aids gathering dust in dressers or desk drawers. The implantable hearing device would eliminate vain excuses for not treating the issue and result in better hearing - every day."
Gan is applying for grant funding from the National Institutes of Health to move forward on researching the mechanics of the inner ear, through the development of a finite element model of the human ear that would help detect and treat common middle-ear infections and disorders. Her team's project has been approved by the U.S. patent office and their research, moving forward, is focusing on the clinical applications of this model.
The University of Oklahoma biomedical engineering program spans research and education activities in biomedical sciences and bioengineering on the Norman, Okla., and Oklahoma City campuses. Its goal is to provide interdisciplinary training of the highest quality to the next generation of biomedical engineers and scientists; serve as a catalyst for innovative interdisciplinary research at the interfaces of biology, engineering and medicine; and be the platform through which new discoveries in biomedical sciences and engineering are translated into clinical technologies and therapies for the prevention, detection, diagnosis and treatment of disease.
The Hough Ear Institute is a nonprofit research, educational and humanitarian service institute. As a Center of Excellence of INTEGRIS Baptist Medical Center, the IBMC Cochlear Implant Clinic and Hearing Enrichment Language Program are an integral part of the institute. HEI also interacts with Otologic Medical Clinic Inc. and Audio Recovery Inc. All of these entities are located within the Hough Ear Institute campus. In addition, research collaborations exist between the University of Oklahoma, Oklahoma Medical Research Foundation and Oklahoma State University.